With help from BA.5, new COVID hospitalizations quadrupled since April

A thrown-away surgical mask lays on the ground.

Enlarge / A thrown-away surgical mask lays on the ground. (credit: Getty | David Gannon)

As the wave of omicron coronavirus subvariant BA.5 continues to flood the US, daily COVID-19 hospitalizations are four times higher than four months ago, according to the latest data from the Centers for Disease Control and Prevention.

The data reflects the high ongoing transmission of coronavirus subvariants adept at evading fading immune responses in a population that is largely unboosted.

In early April, as the US fell into a brief pandemic lull in the wake of the towering BA.1 omicron wave, the seven-day rolling average for new hospitalizations sunk to around 1,420 per day nationwide. Now, after waves of subvariants BA. 2, BA.2.12.1, and the current BA.5, hospitalizations have floated back up. The current seven-day rolling average is nearing 6,300. Overall, more than 37,000 people in the US are currently hospitalized with COVID-19.

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US monkeypox cases hit 1,470; CDC says more coming, and we’re short on vaccines

A vial of the Monkeypox vaccine is displayed by a medical professional at a vaccination site at the Northwell Health offices at Cherry Grove on Fire Island, New York, on July 13, 2022.

Enlarge / A vial of the Monkeypox vaccine is displayed by a medical professional at a vaccination site at the Northwell Health offices at Cherry Grove on Fire Island, New York, on July 13, 2022. (credit: Getty | James Carbone)

US monkeypox cases hit 1,470 this week, and federal officials reported Friday that they expect the tally to continue rising amid expanded testing, continued community transmission, and a current shortage of vaccines. The federal update comes as officials face growing criticism over their handling of the outbreak, and experts fear it may already be too late to contain the virus.

Overall, the multinational monkeypox outbreak has tallied nearly 13,000 cases, with the largest counts in Spain (2,835), Germany (1,859), and the UK (1,856). The US now ranks fourth worldwide. But, it could potentially move up in the ranks quickly.

“We anticipate an increase in cases in the coming weeks,” Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said in a press briefing Friday. Walensky laid out three reasons why they are expecting an upcoming rise.

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Feds may expand 2nd boosters to all adults as anxiety surges over BA.5 wave

Feds may expand 2nd boosters to all adults as anxiety surges over BA.5 wave

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The swift rise of omicron subvariant BA.5—with its increased immune-evading abilities and demonstrable growth advantage—has federal officials on edge. In a flurry of activity late Monday and early Tuesday, officials doubled down on pandemic measures, renewed calls for vigilance, and are considering expanding eligibility of second boosters to all adults.

In a press briefing Tuesday morning, White House COVID-19 Response Coordinator Ashish Jha outlined a battle plan against BA.5, which, as of today, is estimated to account for 65 percent of cases in the US. Jha highlighted efforts and tools to prevent another towering wave of infection as seen with the original omicron in January. The plan includes a stronger push to get Americans vaccinated and boosted, plus renewed encouragement to test, treat, mask, and improve indoor ventilation.

US COVID-19 cases are currently plateaued at a high level of around 117,000 new cases per day—but that’s likely a significant underestimate given that many Americans are testing at home and not reporting their cases. Hospitalizations and intensive care admissions, meanwhile, are rising, with 17 percent and 21 percent increases over the past two weeks, respectively, according to tracking by The New York Times. Generally, the daily average of hospitalizations has more than doubled since the end of May, with the current average nearing 38,000.

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Moderna to make two different omicron boosters: one for US, another for UK, EU

A vial containing Moderna COVID-19 booster vaccine at a vaccination center.

Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center. (credit: Getty | SOPA Images)

The type of COVID-19 booster dose you get later this year could depend on where you live.

Vaccine maker Moderna is working up two omicron-targeting boosters for different countries. If the company’s plans pan out, it will mark the first time that COVID-19 vaccines would target different versions of the pandemic coronavirus in different places. Until now, all vaccines, including boosters, have targeted the ancestral strain of SARS-CoV-2, first identified in Wuhan, China.

Both of Moderna’s next-gen booster candidates are bivalent vaccines, which target both the ancestral virus and some version of omicron. One booster option targets BA.1—the version of omicron that first burst out of South Africa last November, causing a towering wave of infection in the US in January 2022. That BA.1-based next-gen booster could be available in the EU, UK,  Australia, and elsewhere later this month or early August. Moderna’s other booster option targets BA.4/5 and is intended for use in the US. However, it likely won’t be ready until early to mid-fall.

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FDA calls for fall boosters against BA.4/5 as subvariants take over US

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC.

Enlarge / Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC. (credit: Getty | Pool)

On Thursday, the US Food and Drug Administration advised vaccine makers to reformulate COVID-19 booster shots for this fall. The boosters would target both the original strain of the pandemic coronavirus plus two new omicron subvariants—BA.4 and BA.5—which became the dominant versions of the virus circulating in the United States this week.

The FDA’s announcement comes two days after its independent expert advisors voted overwhelmingly in favor of updating boosters to include an omicron component. The vote—19 in favor, two against—was simply in favor of including an omicron component generally. But, in their afternoon-long discussion, experts offered opinions that led to the FDA’s more specific guidance.

Specifically, much of the committee expressed support for combination shots—aka bivalent boosters—that would target both the original virus and a version of omicron. There was also broad support for targeting the omicron subvariants BA.4 and BA.5 specifically, rather than earlier subvariants, such as the first, BA.1, which is no longer in circulation.

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Moderna’s omicron-combo booster outcompetes current booster

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

A combination COVID-19 booster dose that targets the ancestral strain of SARS-CoV-2 and the initial omicron variant, BA.1, appears to outperform the current booster against both of those versions of the virus, Moderna reported Wednesday.

Specifically, Moderna says the combination booster increased neutralizing antibodies against omicron 8-fold, while the original booster only increased antibody levels around 4.4-fold.

The vaccine maker is angling to have this bivalent shot—dubbed mRNA-1273.214—be the go-to booster for seasonal shots this fall. The company will be submitting its data to the Food and Drug Administration in the coming weeks and says it hopes to have the bivalent booster available by late summer, if not early fall.

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FDA advisors overwhelmingly endorse Novavax COVID-19 vaccine

Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022.

Enlarge / Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022. (credit: Getty | Bloomberg )

A committee of independent, expert advisors for the Food and Drug Administration voted overwhelmingly to authorize the two-dose Novavax COVID-19 vaccine Tuesday, with 21 of 22 committee members voting in favor of the vaccine and one member abstaining.

The endorsement is only for a two-dose primary series in adults, not for boosters. The FDA is not obligated to follow the advice of its committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—but the agency typically heeds its advice. If the FDA authorizes the vaccine, the Centers for Disease Control and Prevention will need to sign off on use before it becomes available.

The decision regarding the Novavax vaccine, which is already authorized in dozens of other countries, is not a straightforward one in the US. The vaccine has some advantages over currently approved vaccines but has several strikes against it.

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BA.4, BA.5 gain ground in US, pose higher risk of breakthrough infections

A person holds a positive SARS-CoV-2 rapid test on February 17, 2022 in Berlin, Germany.

Enlarge / A person holds a positive SARS-CoV-2 rapid test on February 17, 2022 in Berlin, Germany. (credit: Getty | Thomas Trutschel)

Omicron subvariant BA.2.12.1 has overtaken BA.2 as the dominant version of the pandemic coronavirus in the US, now accounting for an estimated 59 percent of cases nationwide. But BA.2.12.1’s reign may end as quickly as it began, with yet another batch of omicron subvariants gaining ground—BA.4 and BA.5—and threatening to cause more breakthrough infections.

BA.2.12.1 has a transmission advantage over BA.2, which itself has an edge over the initial omicron subvariant, BA.1, that caused a towering surge of US cases in mid-January. BA.2 peaked in mid-April, accounting for 76 percent of US cases at its height. But then came BA.2.12.1, which is named for being the 12th lineage stemming from BA.2 and the first branch of that BA.2.12 lineage.

When BA.2 peaked in mid-April, BA.2.12.1 accounted for about 18 percent of cases. It reached about 43 percent prevalence by mid-May and has since overtaken BA.2, which currently accounts for only about 35 percent of cases. BA.2.12.1 is dominant in every region of the country, except for the Northwest, according to the Centers for Disease Control and Prevention.

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Everything CDC wants you to know about monkeypox and the current risk level

A negative stain electron micrograph of a monkeypox virus virion in human vesicular fluid.

Enlarge / A negative stain electron micrograph of a monkeypox virus virion in human vesicular fluid. (credit: Getty | BSIP)

The US Centers for Disease Control and Prevention today provided an update on the monkeypox situation in the US, which is connected to a growing multinational outbreak. It also used the time to address open questions and calm some unfounded fears.

To date, there are five confirmed and probable cases in the US. The one confirmed case of monkeypox in the US was identified last week in a Massachusetts man who had recently traveled to Canada. The four probable cases include one in New York City, one in Florida, and two in Utah.

Those four cases are probable because they all tested positive for an orthopoxvirus, the family of viruses that includes monkeypox and smallpox. They are considered presumptive monkeypox cases and are being treated as such while the CDC carries out secondary testing to confirm monkeypox.

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Switch to Moderna booster after Pfizer shots better against omicron in 60+

The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines.

Enlarge / The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo)

People ages 60 and older who were initially vaccinated with two Pfizer-BioNTech COVID-19 vaccine doses were better protected from the omicron coronavirus variant after being boosted with a Moderna vaccine rather than another dose of the Pfizer-BioNTech vaccine.

Those results are according to interim data from a small but randomized controlled clinical trial in Singapore and published this week in the journal Clinical Infectious Diseases.

The study—involving 98 healthy adults—can’t determine if the Moderna booster is simply superior to a Pfizer-BioNTech booster for older adults or if a mix-and-match booster strategy is inherently better. It also focused solely on antibody levels, which may or may not translate to significant differences in infection rates and other clinical differences. It also only followed people for 28 days after a booster, so it’s unclear if the Moderna booster’s edge will hold up over time.

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FDA puts the brakes on J&J vaccine after 9th clotting death reported

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

The US Food and Drug Administration limited the use of the Johnson & Johnson (Janssen) COVID-19 vaccine late Thursday, citing the risk of a very rare but severe clotting disorder called thrombosis with thrombocytopenia syndrome (TTS).

From now on, the J&J vaccine is only to be used in people ages 18 and up who are unable or unwilling to receive an alternative COVID-19 vaccine. That includes people who have had a life-threatening allergic reaction (anaphylaxis) to an mRNA COVID-19 vaccine, people who have personal concerns about mRNA COVID-19 vaccines and would otherwise not get vaccinated, and people who don’t have access to mRNA COVID-19 vaccines.

The limitation comes as the FDA and the Centers for Disease Control and Prevention have been closely monitoring people who received J&J COVID-19 vaccinations for TTS. To date, the agencies have identified and confirmed 60 cases of TTS linked to the vaccine, including nine deaths. That represents a rate of 3.23 TTS cases per million doses of J&J vaccine administered, and a rate of 0.48 TTS deaths per million doses of vaccine administered, the FDA said Thursday.

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Moderna requests FDA authorization for COVID vaccine for kids under 6

Moderna requests FDA authorization for COVID vaccine for kids under 6

Enlarge (credit: Getty | Bloomberg)

In a move highly anticipated by parents the country over, Moderna announced Thursday that it has requested FDA authorization for its two-dose COVID-19 vaccines for children 6 months to 2 years, and 2 years to under 6 years.

If the Food and Drug Administration issues an emergency use authorization (EUA) for the vaccines, they will be the first such vaccines available to the age groups in the now nearly two-and-a-half-year-long pandemic. Parents of young, vaccine-ineligible children have been anxiously awaiting the availability of such vaccines, particularly as much of the country tries to move on from the pandemic even as the number of cases of the extremely contagious omicron subvariants continue to tick upward.

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” Moderna CEO Stéphane Bancel said in a statement Thursday morning. “We believe mRNA-1273 [the COVID-19 vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

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Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

Enlarge (credit: Getty | Congressional Quarterly)

The Food and Drug Administration is considering holding off on reviewing Moderna’s COVID-19 vaccine for children under age 5 until it has data from Pfizer and BioNTech on their vaccine for young children. The plan would push back the earliest possible authorization for a vaccine in the age group from May to June—yet another blow to parents who are anxious to protect their young children as the rest of the country ditches pandemic precautions, despite recent upticks in cases.

The FDA’s plan to delay the review was first reported by Politico Thursday morning, with sources telling the outlet that FDA officials worry about green-lighting Moderna’s vaccine, only to find out just a few weeks later that Pfizer’s offers superior protection.

In an interview with CNN’s Kasie Hunt later in the day Thursday, top infectious disease expert Anthony Fauci confirmed that the regulator is considering waiting until summer, likely June, to authorize vaccines for kids under 5. Fauci said the delay was intended to avoid confusion about the vaccines, but he emphasized that he was not involved in the regulators’ decisions and couldn’t explain their thinking further.

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Combo COVID booster is the way to go this fall, Moderna data suggests

A tray of prepared syringes for booster vaccinations with Moderna's vaccine.

Enlarge / A tray of prepared syringes for booster vaccinations with Moderna’s vaccine. (credit: Getty | Picture alliance)

A COVID-19 booster targeting two versions of the coronavirus in one shot offered stronger and broader protection than the current booster, which targets only one version, according to clinical trial results released this week by vaccine maker Moderna.

The results are preliminary and have not been peer reviewed or published in a scientific journal. But Moderna touted the findings as evidence that bivalent or multivalent vaccines—those that target two or more versions of the virus in a single shot—are the way forward for COVID-19 boosters.

Moderna and other vaccine makers are on a mission to develop boosters that could restore the once extraordinarily high levels of protection that mRNA-based COVID-19 vaccines initially provided, while also protecting against future variants. The first-generation mRNA vaccines were all designed to target the ancestral version of SARS-CoV-2 isolated in Wuhan, China—and they did so quite effectively, showing efficacy against symptomatic disease in the ballpark of 95 percent. But the virus has evolved into variants that can evade vaccine-derived protections. The latest variant, omicron, significantly reduced vaccine effectiveness against symptomatic disease, though protection against severe disease remains strong. Booster doses of the current vaccine design buoy protection but don’t restore the high levels seen previously. And the virus continues to evolve.

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NIH begins trial of COVID boosters to fight future variants

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Mild or not, more SARS-CoV-2 variants are inevitable. To avoid any blips in our pandemic endgame, researchers at the National Institutes of Health on Thursday announced the start of a complex Phase II clinical trial to find the best COVID-19 booster regimen to protect against variants that emerge in the wake of omicron.

“We are looking beyond the omicron variant to determine the best strategy to protect against future variants,” Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said in a statement. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

Evidence so far suggests that the current vaccines—which are based on an early version of SARS-CoV-2 isolated in Wuhan, China—can muster protection against most of the variants that have swept across the globe so far. However, current vaccines have struggled against omicron, an ultratransmissible variant that is the most divergent variant yet. As such, researchers are wary that an omicron-specific vaccine alone will not generate broad protection against any future variant that may be more closely related to past variants—such as beta, a variant first detected in South Africa in 2020 suspected of being more severe than past variants, and delta, a highly transmissible variant that swept through the US before the emergence of omicron.

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Moderna reports good COVID vaccine results for kids

Avery, 6, and Aidan, 11, got their second Moderna COVID-19 vaccine doses at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021, as part of the KidCOVE study evaluating the safety and efficacy of the Moderna vaccine in young children.

Enlarge / Avery, 6, and Aidan, 11, got their second Moderna COVID-19 vaccine doses at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021, as part of the KidCOVE study evaluating the safety and efficacy of the Moderna vaccine in young children. (credit: Getty | MediaNews Group)

Wednesday brought some potentially positive news for the parents and caregivers of young children who have endured an agonizing wait for an effective COVID-19 vaccine. Moderna announced Wednesday that its two-dose vaccine for children ages 6 months to under 6 years appeared safe and produced strong antibody levels that correlate with effectiveness in adults. The company plans to ask the Food and Drug Administration to authorize the vaccine in the coming weeks.

The trial, a randomized, observer-blind, placebo-controlled study called KidCOVE, involved 6,700 children under 6 years old (4,200 children six months to 2 years and 2,500 children 2 years to under 6 years). Vaccinated children received two 25-microgram doses of vaccine—a quarter of the adult dose—which were given 28 days apart. Neutralizing antibody levels in the vaccinated children met or exceeded those seen in adults ages 18 to 25, for which vaccine is already approved.

Omicron hit

Though the primary objective of the trial was to reach those antibody levels seen in adults—a process called an immunobridging study—the trial also looked at efficacy against infection and severe disease amid the wave of omicron coronavirus variant infections. Phase III trial data indicated that the vaccine was about 44 percent effective at preventing an omicron infection in children ages 6 months to 2 years and 37.5 percent effective against an omicron infection in children ages 2 years to under 6 years.

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Murky case for fourth doses now with FDA as protection wanes, BA.2 looms

The US Food and Drug Administration in Silver Spring, Maryland.

Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. (credit: Getty | Xinhua News Agency)

Vaccine-makers Moderna and Pfizer have now both submitted requests for the US Food and Drug Administration to authorize fourth doses—second boosters—of their COVID-19 vaccines.

Pfizer, along with vaccine partner BioNTech, announced Tuesday that they had asked the FDA to authorize fourth doses for adults age 65 and above. The move followed days of Pfizer CEO Albert Bourla saying in press interviews that a fourth shot is “necessary” for everyone.

Late Thursday, Moderna announced that it, too, had asked the FDA to authorize fourth doses—for all adults. Moderna addressed the broader request in its announcement, saying it’s intended to “provide flexibility” for the FDA and the Centers for Disease Control and Prevention to decide for themselves who should get a fourth dose—whether it’s specific age groups and/or groups with higher risks of disease.

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COVID cases are again on the rise globally as testing, health measures decline

World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus (L) and WHO Technical Lead Maria Van Kerkhove attend a daily press briefing on COVID-19 at the WHO headquarters on March 2, 2020, in Geneva.

Enlarge / World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus (L) and WHO Technical Lead Maria Van Kerkhove attend a daily press briefing on COVID-19 at the WHO headquarters on March 2, 2020, in Geneva. (credit: Getty | Fabrice Coffrini)

After weeks of decline, the global tally of COVID-19 cases is now ticking back up. This uptick is raising concerns that we could see yet another surge amid relaxed health measures and the rise of the omicron subvariant BA.2, the most highly transmissible version of the virus identified to date.

According to the latest COVID-19 situation report by the World Health Organization, the global tally of new weekly cases increased 8 percent for the week ending on March 13, totaling over 11 million cases. Cases are increasing in the Western Pacific, European, and African regions. Korea, Vietnam, Germany, France, and the Netherlands reported the highest numbers of new cases.

“These increases are occurring despite reductions in testing in some countries, which means the cases we are seeing are just the tip of the iceberg,” director-general of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, said in a press briefing Wednesday.

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Florida health official put on 2-month leave after urging staff to get vaccine

Florida Gov. Ron DeSantis speaks during a press conference before newly appointed state Surgeon General Dr. Joseph Ladapo at Neo City Academy in Kissimmee, Florida.

Enlarge / Florida Gov. Ron DeSantis speaks during a press conference before newly appointed state Surgeon General Dr. Joseph Ladapo at Neo City Academy in Kissimmee, Florida. (credit: Getty | SOPA images)

Florida is allowing its top public health official in Orlando to return to work after a two-month suspension related to an email he sent to his staff noting their abysmal COVID-19 vaccination rate and urging them to get vaccinated.

Dr. Raul Pino, the health administrator for Florida’s Orange County, sent the email to public health employees on January 4 as the state was seeing a surge of COVID-19 cases amid the omicron wave of the pandemic. The email noted that less than half of the 568 employees at the county’s public health office were fully vaccinated against COVID-19. Only 77 of them had gotten a booster shot, Pino added. He called the staff’s vaccination rate “pathetic” and wrote that it was “irresponsible” not to be vaccinated at that point.

“I have a hard time understanding how we can be in public health and not practice it,” he wrote, according to Click Orlando.

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Here’s how kids’ COVID vaccines are holding up in the real world amid omicron

A nurse gives a 16-year-old a COVID-19 vaccine.

Enlarge / A nurse gives a 16-year-old a COVID-19 vaccine. (credit: Getty | Sopa images)

New data on the real-world effectiveness of COVID-19 vaccines in children and teens largely mirrors what we’ve seen in adults so far: vaccine effectiveness is strong against the delta coronavirus variant but takes a significant hit when up against omicron. Time also erodes protection. But overall, the shots—particularly boosters—offer valuable protection against severe outcomes.

The data, published by the Centers for Disease Control and Prevention this week, drew on medical records from 10 states and only focused on vaccinations with the Pfizer-BioNTech vaccine. Researchers examined records of nearly 40,000 visits of non-immunocompromised children and teens to emergency departments and urgent care centers (ED and UC), as well as about 1,700 hospitalizations, all of which occurred between April 9, 2021, and January 29, 2022.

Expected waning

Across the delta and omicron eras, vaccine effectiveness of two doses against ED/UC visits was 83 percent in children 12 to 15, and 76 percent in teens 16 to 17. But those estimates only go up to five months after the two doses, and we know vaccine effectiveness wanes over time. After the five-month mark, those effectiveness estimates fell to 38 percent and 46 percent for ages 12 to 15 and 16 to 17, respectively.

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Vaccine makers announce slowdowns for omicron-specific booster

Rows of small glass vials.

Enlarge / Vials of undiluted Pfizer COVID-19 vaccine. (credit: Getty | BRENDAN SMIALOWSKI )

Vaccine makers are pushing back when omicron-specific COVID-19 vaccines could be ready for use. The shots were initially expected in March.

Delays in the vaccines’ development come as cases of omicron have been dropping rapidly, and several animal studies have suggested the variant-specific formulations will not offer an advantage over the current vaccines.

BioNTech CEO Uğur Şahin on Wednesday said that his company’s omicron-specific vaccine had been delayed by several weeks due to unexpectedly slow data gathering, according to Reuters. BioNTech and its COVID-19 vaccine partner, Pfizer, had announced last month that they had begun a clinical trial with the omicron-specific shot.

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FDA, Pfizer abandon 2-shot COVID vaccine in kids under 5, citing new data

A small person looks at the band-aid being applied to their arm.

Enlarge / A child getting a vaccination on February 19, 2021, in Bonn, Germany. (credit: Getty | Ute Grabowsky)

The Food and Drug Administration, Pfizer, and BioNTech announced on Friday that they are abandoning plans to pursue the authorization of a two-dose regimen of COVID-19 vaccines for children ages six months to four years. Instead, they will again put the possibility of an authorization on hold as they await data on the efficacy of a third dose for the youngest children. That data is now expected in early April.

In a press release this afternoon, Pfizer and its partner BioNTech reported that COVID-19 cases among children enrolled in the initial two-dose trial “continue to accumulate according to the study protocol, and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent omicron surge.”

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the press release continued.

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Omicron-specific vaccine boosters are now in humans as trials begin

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

The first doses of omicron-specific COVID-19 vaccines went into the arms of clinical trial participants this week. This takes place just as the towering wave of cases from the ultratransmissible coronavirus variant appears to be cresting in the US and experts are unsure of what to expect next.

Leading mRNA-based vaccine makers Moderna and partners Pfizer and BioNTech each announced this week that they had dosed their first trial participants. The tweaked vaccine doses update existing formulations to match the mutations found in omicron’s spike protein rather than the spike protein present in an earlier version of SARS-CoV-2.

The companies all emphasized that three doses of existing vaccines—two doses in the primary series, followed by a booster dose—are holding up against omicron. The doses provide strong protection from severe disease, hospitalization, and death, say the companies. Last week, the Centers for Disease Control and Prevention published data suggesting that three doses are 82 percent effective at preventing visits to urgent care clinics and emergency departments for COVID-19. Three doses, the CDC added, are also 90 percent effective at preventing hospitalization.

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People with this certain gene version less likely to develop severe COVID-19

omicron


The new results show that people with a specific version of a gene are less likely to develop severe COVID-19. Earlier research had identified a specific group of genes, called the OAS1/2/3 gene cluster, as being involved in the risk for severe COVID-19. 

One version of a gene in that cluster –passed down from Neanderthals, appeared to protect against serious disease, reducing  risk by about 23%. Previous research was mostly done on people of European ancestory. Researchers are now seeing the same association of this genetic variant with less severe COVID-19 in people of African ancestory, according to a report published in Nature Genetics.

 “The fact that people of African descent had the same protection allowed us to identify the only variant in  DNA that actually protects against COVID19 infection. co-author dr. Jennifer Huffman  said in a statement.

 OAS genes are involved in a cascade of effects that help cells fight viruses, the researchers said. Understanding these genes and their impact on COVID19 risks could aid in the development of future drugs, they added.

Fewer Delta breakthroughs with Moderna vs Pfizer/BioNTech

When the delta variant  coronavirus was widespread in the United States, recipients of two doses of Moderna’s mRNA vaccine (MRNA.O) were less likely to have breakthrough infection  and  were slightly less likely to be hospitalized  than recipients of two doses of  mRNA vaccine from Pfizer and BioNTech, found a large study. 

The researchers analyzed the medical records of more than 637,000 vaccine recipients who had not previously been infected with the virus and had not received a booster shot.

 As reported in JAMA on Thursday, advanced infections increased steadily each month from July through November 2021, with higher rates in the Pfizer/BioNTech group. 

In November, there were 2.8 cases per thousand people vaccinated with the Pfizer/BioNTech injections compared to 1.6 cases per thousand recipients of the Moderna vaccines.

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Scientists scrutinise characteristics of new Omicron sub-variant

 

Image Credit:CIPhotos via Getty Images


Studies are underway to find out the precise characteristics of the latest Covid-19 variant ‘BA.2’. It already accounts for the majority of most recent cases in a number of countries, including India, Denmark and Sweden. But, for French Health Minister Olivier Véran, this sub-variant’s arrival in France is not “a game changer”.

BA.2, nicknamed “Omicron’s little brother”, made its first appearance in France a few weeks ago. Mentioned for the first time by Véran during a press conference on January 20, this new Covid-19 derivative is being scrutinised by scientists.

  • Where does BA.2 come from?  

BA.2 was first identified in India and South Africa in late December 2021. It is a sub-variant, believed to have emerged from a mutation of Omicron (officially known as BA.1). Omicron itself was born from a mutation of Delta. Other sub-lineages have already been referenced, such as BA.3 or BB.2, but they have attracted less attention from epidemiologists because of the dramatic increase in cases of people who have contracted BA.2.

BA.2 has more than 20 mutations, about half of them in the spike protein. This is the famous protein that interacts with human cells and is the key to the virus entering the body.

  • Is this sub-variant as dangerous as Omicron?  

The World Health Organization (WHO), which had classified Omicron as a “variant of concern”, does not at this stage distinguish between it and its BA.2 sub-lineage. For his part, Véran said that “as far as we know at the moment, it corresponds more or less to the characteristics we know about Omicron”. It is not “a game changer” at this stage, added Véran in an attempt to reassure.

BA.2 is being closely studied by the scientific community, but there is as yet no precise data on its resistance to vaccines or the severity of the cases of Covid-19 it causes. Scientists are beginning to speak out on the subject, while remaining cautious.

Virologist Tom Peacock of Imperial College London tweeted that “very early observations from India and Denmark suggest there is no dramatic difference in severity compared to BA.1. This data should become more solid (one way or another) in the coming weeks.”

Peacock added that “there is likely to be minimal differences in vaccine effectiveness against BA.1 and BA.2. Personally, I’m not sure BA.2 is going to have a substantial impact on the current Omicron wave of the pandemic.

“Several countries are near, or even past the peak of BA.1 waves. I would be very surprised if BA.2 caused a second wave at this point. Even with slightly higher transmissibility this absolutely is not a Delta-Omicron change and instead is likely to be slower and more subtle,” he predicted.

For epidemiologist Antoine Flahault, director of the University of Geneva’s Institute of Global Health, infection monitoring should make it possible to test the resistance of BA.2, in particular if people infected with the classic Omicron are again contaminated with the sub-variant. However, it is necessary to have the means to detect contamination with BA.2 in the population, which seems delicate at this stage and which does not seem to be self-evident.

  • Why is BA.2 so difficult to trace?  

BA.2 poses certain challenges to scientists, as it is not easy to track. A variation in PCR test protocols and the fact that the type of kit varies from one laboratory to another makes it difficult to reliably identify BA.2, according to Florence Débarre, a biologist at the Institute of Ecology and Environmental Sciences in Paris, interviewed by Libération. “In the UK, the way the tests are carried out does not allow us to distinguish between BA.2 and Delta,” explains Débarre.

There is a more accurate but less commonly used tool for tracking variants: genetic sequencing of the virus. This allows the exact presence of this sub-variant to be identified. But in France, for example, only some of the laboratory tests are randomly subjected to this more in-depth and expensive form of analysis. Sequencing also has the drawback of being slow, which means it is not suitable for monitoring a rapidly spreading variant.

  • Where is BA.2 most dominant? 

The sub-variant has been detected in at least 43 countries on all continents. It is believed to have become the most common variant in a number of countries, including India, Denmark and Sweden. In Denmark, the number of daily cases of Covid-19 has started to rise again, just when the Danes thought they had already reached the peak.

The UK Health Security Agency (UKHSA) identified more than 400 cases in Britain in the first 10 days of January.

“The Danish authorities have no explanation for this phenomenon, but it is being closely monitored,” said France’s public health agency, which is following the latest developments in Denmark. This “suggests that BA.2 is even more transmissible”, agreed Débarre. In Europe, BA.2 has also been sequenced in the UK, Germany, Belgium, Italy and France, while North America, Asia and Australia have recorded cases, too.

  • Is BA.2 evolving as fast in France?

To date, the sub-variant has been detected “at very low levels” in France, says France’s public health agency. “We have an international situation where the Omicron variant is circulating a lot, so it is normal that we observe sub-variants over time,” the agency said on January 21.

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Unvaccinated 5X more likely to get omicron than those boosted, CDC reports

A tray of prepared syringes for booster vaccinations with Moderna's vaccine.

Enlarge / A tray of prepared syringes for booster vaccinations with Moderna’s vaccine. (credit: Getty | Picture alliance)

Amid the stratospheric rise of the omicron variant, real-world data on the effectiveness of COVID-19 booster doses is now rolling in—and it is only looking up for boosters.

The Centers for Disease Control and Prevention reported three studies Friday, two published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) and another, appearing in JAMA, by CDC scientists.

One of the MMWR studies looked at the vaccination status of nearly 10 million COVID-19 cases from 25 state and local health departments. CDC scientists and health officials compared weekly rates of COVID-19 infections between unvaccinated people, fully vaccinated people, and fully vaccinated people who were also boosted. In the month of December, as cases of the ultra-transmissible omicron variant skyrocketed, unvaccinated people were nearly three times more likely to report a case of COVID-19 than people fully vaccinated. Compared with fully vaccinated and boosted people, the unvaccinated were five times more likely to report a case.

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AUSTRIA ADDS A LOTTERY TO COVID VACCINE MANDATE

A doctor vaccinates a person with a dose of the Pfizer-BioNTech COVID-19 vaccine in Vienna, Austria April 26, 2021. REUTERS/Lisi Niesner

Austria’s conservative government said  Thursday it was launching a national lottery to encourage holdouts to get vaccinated against the coronavirus, hours before parliament passed legislation that would introduce a national vaccination mandate. 

About 72% of the Austrian population is fully vaccinated against COVID-19, one of the lowest rates in Western Europe. “What’s up for grabs in the Vaccine Fleet?” Vouchers!”

 This is what Federal Chancellor Karl Nehammer said at a press conference  of the social democratic opposition leader Pamela Rendi Wagner, with whom the measure was being negotiated.

Nehammer said he wanted there to be a financial reward for getting vaccinated, adding: “We have learned from the past and we have seen that a vaccination lottery is the best possible way to set up such a system.”

Members of the public, whether already vaccinated or not, would be entitled to one ticket for each shot they have had – three in total for those who have had their booster shot.

Every 10th ticket would win a 500 euro ($568) gift voucher, Nehammer said, adding it would cost up to 1 billion euros. He later added on Twitter that the vouchers could be used in “retail, tourism, hospitality, services, culture and sport”.

Vice Chancellor Werner Kogler said the aim was to support Austrian businesses and avoid online retailers as much as possible.

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CHEAP VERSION OF MERCK COVID PILL TO BE MADE FOR POORER NATIONS

An experimental COVID-19 treatment pill, called molnupiravir and being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters May 17, 2021. Merck & Co Inc/Handout via REUTERS
A UN-backed agency has struck a deal with nearly 30 generic drugmakers to make low-cost versions of Merck’s COVID-19 pill molnupiravir for poorer countries, expanding access to a drug seen as a weapon to fight the pandemic. 

The antiviral drug, which  received emergency use approval in the US in December, reduces hospitalizations and deaths  by about 30% in high-risk patients, according to clinical trials. 
The agreement, negotiated by the U.N.-backed Medicines Patent Pool (MPP) with Merck, allows 27 generic drugmakers from India, China and other countries in Africa, Asia and the Middle East to manufacture ingredients and the finished drug. 

The MPP said on Thursday the agreement would see the pill  distributed to 105 least developed countries.

The developers of molnupiravir, which together with Merck are the US company Ridgeback Biotherapeutics and Emory University, will not receive royalties from the sale of cheap versions made by generic drug companies as long as COVID-19 is classified as a public health emergency by the World Health Organization (WHO) .

 “This is a critical step in ensuring global access to a much-needed COVID-19 treatment, and we are confident that with manufacturers  working closely with regulatory authorities, pre-treatments will be rapidly available,” said MPP CEO Charles Gore .

Bangladesh’s Beximco Pharmaceuticals, India’s Natco Pharma, South Africa’s Aspen Pharmacare and China’s Fosun Pharma are among the generic drug companies that will manufacture the final product.

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WHO says no evidence healthy children, adolescents need COVID-19 boosters

Photo Credit: Fabrice Coffrini | Reuters

At present, there is no evidence  that healthy children and adolescents need booster doses of the COVID-19 vaccine,  World Health Organization chief scientist Soumya Swaminathan said on Tuesday. 

Speaking at a news briefing, she said that while there seems to be some waning of vaccine immunity over time against the fast-spreading Omicron variant of the coronavirus, more research is needed to determine who needs a booster shot.

“There is currently no evidence  that healthy children or heavy adolescents need boosters. No evidence at all,” he said. 

Israel began offering boosters to children as young as 12, and the U.S. Food and Drug Administration earlier this month authorized the use of a third dose of the Pfizer and BioNTech COVID-19 vaccine for children aged 12 and 15. 

Last week, Germany became the latest country to recommend that all children between the ages of 12 and 17 receive a COVID-19 booster shot. Hungary did it too.

Swaminathan said the WHO’s top group of experts would meet later this week to consider the specific question of how countries should consider giving boosters to their populations.

“The aim is to protect the most vulnerable, to protect those at highest risk of severe disease and dying. Those are our elderly populations, immuno-compromised people with underlying conditions, but also healthcare workers,” she said.

 

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Pfizer CEO: Virus will be here for years but this may be last wave with restrictions

Pfizer CEO
Pfizer CEO Albert Bourla speaks during a ceremony in Thessaloniki, Greece, on October 12, 2021. (AP Photo/Giannis Papanikos, File)

Pfizer CEO Albert Bourla said on Monday that while the “most likely scenario” is that the coronavirus will circulate for many years, he believes the current wave of infections will be the last to require restrictions.

Bourla gave an interview to the French medium BFM. TV to commemorate the announcement of an investment package by the pharmaceutical company in France. Bourla also touted the vaccines’ effectiveness and safety, saying  he believed people would still need booster shots. “It’s important that people get Pfizer’s three-dose regimen. coronavirus vaccine and will likely  require yearly booster shots, although the immunocompromised may need them every four months,” Bourla said.

“Children need to be vaccinated  to protect them. Its effectiveness in children is very, very, very good. Bourla also said  the company’s anti-COVID pill, Paxlovid, is “changing everything” as a new way to fight serious illnesses. Pfizer said in December that its Paxlovid pill had reduced hospitalizations and deaths by nearly 90 percent in vulnerable people.

In the interview, Bourla said the company was working on a plan that would invest 520 million euros ($593.7 million)  in France over the next five years, including a partnership with French company Novasep to develop an anti-inflammatory treatment -COVID pills.

France, like many other countries, is facing a record number of infections caused by the highly contagious Omicron variant. France’s parliament passed legislation on Sunday barring unvaccinated people from all restaurants, sports stadiums and other venues, the centerpiece of the government’s effort to protect hospitals. in the middle of the wave.

The government of French President Emmanuel Macron is hoping the step will be enough to limit the number of patients filling up strained hospitals nationwide without resorting to a new lockdown.

More than 76% of French ICU beds are occupied by virus patients, most of them unvaccinated, and some 200 people with the virus are dying every day. Like many countries, France is in the grip of the Omicron variant, recording more than 2,800 positive cases per 100,000 people over the past week.

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A healthcare worker administers…

A healthcare worker administers the coronavirus disease (COVID-19) vaccine to a pregnant woman, amidst the spread of the SARS-CoV-2 variant Omicron, in Johannesburg, South Africa, December 9, 2021. REUTERS/ Sumaya Hisham
A healthcare worker administers the coronavirus disease (COVID-19) vaccine to a pregnant woman, amidst the spread of the SARS-CoV-2 variant Omicron, in Johannesburg, South Africa, December 9, 2021. REUTERS/ Sumaya Hisham

Unvaccinated people infected with the Omicron variant of coronavirus may be less prone to severe illness and requiring hospital care or dying than was the case with previous variants, a South African study showed on Friday.

The study, by the National Institute of Communicable Diseases (NICD) in the Western Cape region, which has not yet been peer-reviewed, concluded.compared about 11,600 patients from the first three COVID-19 waves with about 5,100 from the Omicron-driven wave that began in November.

Omicron globally has tended to cause less severe disease, and proportionally fewer hospital admissions and deaths, than previous variants.

Scientists are trying to determine the extent to which this is because of higher immunity rates engendered by vaccination or past illness, or Omicron is intrinsically less nasty.

The study concluded that about a quarter of the reduced risk of severe disease with Omicron was attributable to characteristics of the virus itself.

“In the Omicron-driven wave, severe COVID-19 outcomes were reduced mostly due to protection conferred by prior infection and/or vaccination, but intrinsically reduced virulence may account for an approximately 25% reduced risk of severe hospitalisation or death compared to Delta,” the study said.

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AstraZeneca says third dose helps against Omicron

AstraZeneca vaccine
A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic/Illustration

AstraZeneca said on Thursday that preliminary data from a trial showed that its COVID-19 shot, Vaxzevria, generated an increase in antibodies against the Omicron and other variants when given as a third booster dose.

The increased response, also against the Delta variant, was seen in a blood analysis of people who were previously vaccinated with either Vaxzevria or an mRNA vaccine, the drugmaker said, adding that it would submit this data to regulators worldwide given the urgent need for boosters.

AstraZeneca has developed the vaccine with researchers from the University of Oxford, and lab studies conducted by the university last month already found a three-dose course of Vaxzevria boosted antibody levels in the blood against the rapidly spreading Omicron variant.

The brief statement on Thursday, which did not include specific data, was the first by AstraZeneca on the protective potential of Vaxzevria as a booster shot following a two shot-course of either an mRNA based vaccine or Vaxzevria. Vaccines base on mRNA technology are made by BioNTech-Pfizer and Moderna.

The company said the findings “add to the growing body of evidence supporting Vaxzevria as a third dose booster irrespective of the primary vaccination schedules tested”.

The data on Vaxzevria’s potential as a booster came from a comparative analysis in a trial testing a redesigned vaccine which uses the vector technology behind Vaxzevria but targeting the now-superseded Beta variant. AstraZeneca is trying to show the Beta-specific vaccine has potential also against other variants and more trial data is expected during the first half of the year.

Separately, Oxford University and AstraZeneca last month started work on a vaccine specifically targeting Omicron though Astra – as well as other vaccine makers in similar development projects – have said it was not yet clear whether such an upgrade was needed.

A major British trial in December found that AstraZeneca’s shot increased antibodies when given as a booster after initial vaccination with its own shot or Pfizer’s, but that was before the explosive spread of the Omicron variant.

However, the study at the time concluded that mRNA vaccines made by Pfizer and Moderna gave a biggest boost to antibodies when given as a third dose.

AstraZeneca and its contract manufacturing partners have supplied over 2.5 billion doses globally of its vaccine, even though it is not approved in the United States, while BioNTech-Pfizer have shipped about 2.6 billion doses.

Source: ARY News

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Omicron May Infect Half of Europeans Within Weeks, WHO Says

Image Credit:CIPhotos via Getty Images


 More than half of Europe’s population could become infected with omicron within weeks at current transmission speeds, a World Health Organization official said.

The fast-spreading variant represents a “west-to-east tsunami sweeping  the region,” Hans Kluge, WHO regional director  for Europe, said in a briefing Tuesday. 

He cited  the Institute for  Metrics and Health Assessment forecast that most Europeans could take it within the next six to eight weeks.

The latest Covid  surge has  resulted in fewer symptomatic cases and lower death rates than in previous waves, fueling optimism that the pandemic may subside. 

However, the WHO has repeatedly warned against underestimating the Omicron strain as mild. Kluge said hospital admission rates are increasing. In Europe, it puts pressure on health systems. 

On the flip side, another WHO official said it was too early to consider  COVID-19 is entering an endemic phase, an issue the Spanish government has proposed to discuss. An endemic phase would see “stable spread of the virus at a predictable level”, but what we are currently seeing for 2022 is nowhere near that, “said Catherine Smallwood,  WHO Europe Chief Emergency Officer.” We still have great uncertainty. 

We still have a virus that evolves pretty quickly and brings new challenges, “he said.” We are certainly not at the point where we can call it endemic.

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MODERNA CEO SAYS PEOPLE MAY NEED ANOTHER BOOSTER IN FALL OF 2022

Moderna vaccine
A pharmacist holds a vial of the Moderna coronavirus disease (COVID-19) vaccine in West Haven, Connecticut, U.S., February 17, 2021. REUTERS/Mike Segar

The effectiveness of COVID-19 boosters  is likely to wane in the coming months, and people may need another shot in the fall of 2022, Moderna Inc CEO Stéphane Bancel told a  conference on Thursday on health conference organized by Goldman Sachs. 

Bancel said the company is working on a  vaccine candidate for the Omicron variant of the coronavirus, but it is unlikely to be available in the next two months.

“I still believe we’re going to need boosters in the fall of ’22 and forward,” Bancel said.


His comments on needing a fourth shot come on the back of Israeli Prime Minister Naftali Bennett citing a study on Tuesday that a fourth dose of COVID-19 vaccine boosts antibodies five-fold a week after the shot is administered.


Moderna, which benefits by repeat inoculations, during its third quarter earnings results said commercial booster market sales could be up to $2 billion in the United States in 2022

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French parliament approves Macron’s vaccine pass

 

People wearing protective face masks walk in the Tuileries Gardens in Paris amid the coronavirus disease (COVID-19) outbreak in France,
People wearing protective face masks walk in the Tuileries Gardens in Paris amid the coronavirus disease (COVID-19) outbreak in France, January 5, 2022. REUTERS/Gonzalo Fuentes

The French parliament on Thursday approved President Emmanuel Macron’s plans for a vaccination card to  curb the spread of the Omicron variant after Macron sparked a tumultuous debate whipped up by Macron’s comments that he wanted to “piss off” the unvaccinated.

Macron told Le Parisien  earlier this week. that he wanted to make life so difficult for those who opposed the COVID-19 vaccine  by leading them away from public places that they would end up being jabbed.
Macron’s coarse language barely three months before a presidential election was widely seen as a politically calculated, tapping into a intensifying public frustration against the unvaccinated.

More than 90% of over-12s have received at least two doses, government data shows. Health Minister Olivier Veran said a record number of people since Oct. 1 received a first shot on Wednesday after Macron’s comments were published.


Lawmakers in the lower house passed draft legislation including the vaccine pass shortly after 5 a.m. after an all-night session by a margin of 214 to 93. Many of those who voted against the bill were from the far-right or left-wingers.


The legislation will go to the Senate before a final vote in the National Assembly.

People in France have for several months had to show either proof of vaccination or a negative COVID-19 test to enter venues such as cinemas and cafes and use trains. But with Delta and Omicron variant infections surging, the government decided to drop the test option in the new bill.

The vaccine pass rules will apply to over-16s and not over-12 as the government had initially sought.
European countries have grappled with the possibility of mandating citizens to force them to vaccinate. Italy on Wednesday made the COVID-19 vaccination mandatory for people aged 50 and over,  teachers and public health workers are already required to get vaccinated. , Prime Minister Jean Castex said.
Countries that had switched to compulsory vaccination, such as Italy and Austria, had lower vaccination rates than France.

Castex also said France would be ready to move on to a fourth COVID vaccine shot when the time was right.
On Wednesday, France set a record of more than 332,000 new ones. COVID-19 cases in the past 24 hours and an additional 246 COVID-19 deaths in hospitals, as the country.

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Pfizer, BioNTech to jointly develop shingles vaccine

Pfizer headquarters in New York. Getty Images
Pfizer headquarters in New York.




Pfizer and Germany’s BioNTech announced on Wednesday that they would develop a potential mRNA-based vaccine for the prevention of viral  shingles, working together for the third time after the success of their COVID-19 vaccine.

 Pfizer partnered with BioNTech in 2018 for an influenza vaccine and again in 2020 to develop the COVID-19 vaccine which has been used around the world and  brought in billions of dollars in corporate sales.

The companies plan to begin clinical trials of the shingles vaccine, which will combine antigen technology recognized by scientists at Pfizer  with BioNTech’s mRNA platform technology, in the second half of 2022. 

Shingles, also known known as herpes zoster, usually develops in older people who had chickenpox or varicella-zoster virus when they were younger. 

Its hallmark is a painful rash that goes away within a month in most cases. In some cases, however, this leads to nerve pain which can persist for much longer collaboration, BioNTech will receive $225 million in upfront payment and be eligible  for future regulatory and commercial payments of up to $200 million. BioNTech will pay Pfizer $25 million for the company’s proprietary antigen technology.

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Judge blocks Navy vaccine rule: “No COVID-19 exception to the First Amendment”

Nurse wearing a mask and Navy uniform prepares a vaccine.

Enlarge / A Navy nurse prepares a syringe. (credit: Getty Images | petesphotography)

US Navy Seals who objected to COVID vaccination on religious grounds yesterday won a preliminary injunction that prohibits the Navy from enforcing its vaccine mandate.

“Thirty-five Navy Special Warfare service members allege that the military’s mandatory vaccination policy violates their religious freedoms under the First Amendment and Religious Freedom Restoration Act,” Judge Reed O’Connor wrote in the ruling out of US District Court for the Northern District of Texas. “The Navy provides a religious accommodation process, but by all accounts, it is theater. The Navy has not granted a religious exemption to any vaccine in recent memory. It merely rubber stamps each denial.”

O’Connor, who was nominated by President Bush in 2007, found that the Navy service members are likely to win the case on the merits. He granted the injunction prohibiting the Navy from enforcing its mandate against the plaintiffs and “from taking any adverse action against Plaintiffs on the basis of Plaintiffs’ requests for religious accommodation.”

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Experts warn Omicron ‘blizzard’ to disrupt U.S. for next month

Omicron

Health experts warned Americans on Thursday  that a rising tide of COVID19 cases, led by the Omicron variant, threatened major disruptions in their lives, from schools to shopping, and urged them to prepare now for a challenging month.

The United States had a record seven-day average of new cases, with more than 290,000 new infections reported daily, a Reuters tally showed.

According to the record, at least 18 states and Puerto Rico have set pandemic records for new cases. Maryland, Ohio and Washington, DC also saw record hospital admissions as  U.COVID hospital admissions rose 27%.

The increase is due to an increase in vacation travel as New Years celebrations are yet to come and  schools grapple with students returning to classrooms after the winter break.

“We will see the number of cases in this country rise so dramatically that it will be difficult for us to keep everyday life going,” said Dr. Michael Osterholm, an infectious disease expert from the University of Minnesota, told MSNBC.


“Next month is going to be a viral blizzard,” he said. “It is putting pressure on society as a whole. Dr. Anthony Fauci, the nation’s leading infectious disease official, said Wednesday that cases are likely to increase by the end.

” He and other U.S. health officials  said early data shows Omicron appears less severe, but they have continued to push for vaccines, masks, and physical distance.

Services, schools and retailers among others in the coming weeks. “We have to be very careful not to underestimate Omicron too much,” said Dr. Peter Hoetz, an infectious disease expert at Baylor College of Medicine, told CNN.

It is also worrying that healthcare workers are being marginalized with their own COVID cases  as well as less effective therapies, said Hoetz.

“We are at a pretty serious time. As early as early 2020, 825,663 people  in the United States have died of COVID, the data showed, with the latest wave of hospital admissions for the unvaccinated being driven.

” President Joe Biden announced new news this month. plans to tackle the Omicron-powered wave, including federal reinforcements to hospitals and more testing, but some experts say it’s too little and too late.


So far, however, the economy appears to be stable, even if some economists are cautioned. While air traffic was largely disrupted and stores closed and events canceled in some troubled areas, other measures  such as the Christmas sales were maintained.

The labor market is also  holding up: the new applications for state unemployment benefits fell last week to the lowest level in the pandemic era, the Ministry of Labor announced on Thursday. small businesses, he said he expected the first week of January to be slower than Omicron’s forecast.

“The rest of January will likely depend on state and community health policies and epidemiological data,” Greenberg told Reuters. Keys, especially for working parents, with systems in Washington and New York promising to stay open with further testing.

Education Minister Miguel Cardona admitted the problem was staffing  but urged schools to take measures to keep the children in classrooms. Unlike last year’s closings, “we now have better tools. They should stay open, ”he told MSNBC, adding that federal funding continues to be available to increase staffing levels and testing.

In the meantime, some universities have postponed their next semesters or have gone online. “We have light at the end of the tunnel,” said Osterholm. “But now you have to duck.

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Scientists Identify antibodies that can kill the Omicron variant of the Coronavirus

Image Credit:CIPhotos via Getty Images By Denise Chow

A global team of scientists has discovered antibodies that can kill the variant responsible for the rise of Omicron around the world. In addition, the scientists claim that these antibodies can neutralize other variants of Covid19 as well.


New treatments may be explored

According to one of the study researchers, David Veesler of the Howard Hughes Medical Institute and the University of Washington School of Medicine, the antibodies work by targeting areas of the virus spike protein that are unchanged by mutations. Protein, scientists can develop vaccines and antibody treatments that  work not only against the Omicron variant, but also against any mutation that may occur in the future.

The Omicron variant of the coronavirus has 37 mutations in its spike protein, which is considered an unusually high number for a virus. For this reason, countries like the US and UK are urging citizens to get a booster dose (a third vaccination) to increase the body’s antibody response in the event of infection. Studies have shown that the variant, while  less fatal, is more transmissible and able to evade the protection offered by vaccines designed with previous variants in mind.

Why the virus keeps mutating

If the virus continues to mutate (which it won’t if the vaccine inequality is not addressed), one day a more deadly and  transmissible variant could emerge that could spark another  wave of infections like the one seen during the Delta wave in India.

The team behind the antibody identification  believe that Omicron mutations could be due to a weakened immune system in a person infected with the variant. It is also possible that the virus jumped from humans to animals and then back to humans.

The researchers also found that the Moderna, Pfizer / BioNTech, and AstraZeneca (Covishield) vaccines offered some  protection against Omicron, unlike Sputnik V, Sinopharm, and Johnson and Johnson, which did not show the ability of Omicron to penetrate cells prevent. 

#vaccine

Omicron is rising rapidly in the US—3% of cases nationally, 13% in NY and NJ

A woman on a stretcher is pulled from an ambulance.

Enlarge / Medical workers carry a patient to a hospital in New York, the United States, Dec. 13, 2021. (credit: Getty | Xinhua News Agency )

Health officials sounded the alarm Tuesday over the fast spread of the omicron coronavirus, which has now been detected in 77 countries worldwide and 33 states in the US—and is expanding quickly.

Only two weeks have passed since health officials detected the first omicron case in the US, and the variant is already accounting for 3 percent of cases overall in the country—which is still swept up in a powerful wave of the delta variant. In New York and New Jersey, omicron accounts for 13 percent of cases, according to Rochelle Walensky, director of the Centers for Disease Control and Prevention.

Surge upon surge

Currently, the US is seeing around 120,000 new COVID cases per day, a 49 percent increase over two weeks ago. The country is averaging 66,500 hospitalizations a day, which is a 22 percent increase. For now, nearly all of the cases and hospitalizations are due to delta, but that will likely change quickly with omicron.

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#covid-19, #delta, #disease, #infectious-disease, #omicron, #public-health, #science, #severity, #transmission, #vaccine, #variant

FDA authorizes boosters for ages 16 and 17 ahead of holidays, omicron

FDA authorizes boosters for ages 16 and 17 ahead of holidays, omicron

Enlarge (credit: Getty | Noam Galai)

The Food and Drug Administration on Thursday authorized the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose in teens ages 16 and 17.

The authorization stands to expand access to boosters amid a crushing wave of delta transmission, fears over the looming omicron variant, and the approach of end-of-year holiday gatherings. Currently, boosters are open and recommended for all adults ages 18 and up.

Earlier this week, a crop of preliminary data suggested that boosters will likely be necessary to protect against the omicron variant, which appears to dodge protective immune defenses from both vaccination and prior infection. Previously, data indicated that vaccine effectiveness wanes against delta and previous variants after six months.

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#boosters, #cdc, #covid-19, #fda, #science, #teens, #vaccine

Willfully unvaccinated should pay 100% of COVID hospital bills, lawmaker says

People associated with the far-right group America First attend an anti-vaccine protest in front of Pfizer world headquarters on November 13, 2021, in New York City.

Enlarge / People associated with the far-right group America First attend an anti-vaccine protest in front of Pfizer world headquarters on November 13, 2021, in New York City. (credit: Getty | Stephanie Keith)

People who choose to remain unvaccinated and subsequently become severely ill with COVID-19 should be responsible for paying the entirety of their hospital bills out of pocket, according to Illinois Representative Jonathan Carroll.

The Democrat from the Chicago suburb of Northbrook introduced legislation Monday that would amend the state’s insurance code so that accident and health insurance policies in 2023 would no longer cover COVID-19 hospital bills for people who choose to remain unvaccinated. Carroll said the rule would not apply to those with medical conditions that prevent vaccination.

The bill will likely face considerable political and legal opposition. Most notably, federal law prevents insurers from denying coverage or increasing rates based on a change in a person’s health status, such as a new diagnosis of COVID-19.

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#covid-19, #hospitalization, #infectious-disease, #insurance, #pandemic, #public-health, #science, #unvaccinated, #vaccine

Judge blocks Biden vaccine rule, citing “liberty interests of the unvaccinated”

President Joe Biden speaks in front of a sign advertising the vaccines.gov website.

Enlarge / President Joe Biden speaks about the authorization of the COVID-19 vaccine for children ages 5-11 on November 03, 2021, in Washington, DC. (credit: Getty Images | Drew Angerer )

A federal judge yesterday blocked a Biden administration COVID-19 vaccine mandate for health care workers, granting a request for preliminary injunction filed by Republican attorneys general from 14 states.

US District Judge Terry Doughty ruled that the government lacks authority to implement the rule that “requires the staff of twenty-one types of Medicare and Medicaid healthcare providers to receive one vaccine by December 6, 2021, and to receive the second vaccine by January 4, 2022.” Providers that don’t comply face penalties, including “termination of the Medicare/Medicaid Provider Agreement.”

The Centers for Medicare and Medicaid Services (CMS) mandate regulates over 10.3 million health care workers in the US, of which 2.4 million are unvaccinated. The Biden vaccine rule is being challenged by the attorneys general from Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, and Ohio. The Republican AGs’ lawsuit was filed against CMS and the US Department of Health and Human Services.

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#biden, #policy, #vaccine

US preps vaccine contingencies amid panic over poorly understood omicron

Two white-haired men in suits speak at a podium.

Enlarge / WASHINGTON, DC – NOVEMBER 29: Anthony Fauci (R), Director of the National Institute of Allergy and Infectious Diseases and Chief Medical Advisor to the President, speaks alongside US President Joe Biden as he delivers remarks on the Omicron COVID-19 variant following a meeting of the COVID-19 response team at the White House. (credit: Getty | Anna Moneymaker)

Amid global panic over the recently identified omicron coronavirus variant, US President Joe Biden on Monday urged Americans to stay calm and continue following health measures known to be highly effective at combating COVID-19—namely, masking, vaccination, and boosting.

“This variant is a cause for concern, not a cause for panic,” Biden said in remarks delivered from the White House Monday. He touted the power of current vaccines and America’s scientific prowess in being able to address the potential threat. “We’ll fight this variant with scientific and knowledgeable actions and speed—not chaos and confusion.”

Flanking Biden during the remarks was top infectious disease expert Anthony Fauci. Earlier today, Biden huddled with Dr. Fauci and the rest of the White House COVID-19 Response Team to discuss the threat of omicron. Biden reported that, so far, Fauci and the team believe that current vaccines will “provide at least some protection” against omicron—particularly against severe disease—and that booster doses “strengthen that protection significantly.”

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Child COVID cases are on the rise, jumping 32% in latest surge

A health care worker prepares to administer Pfizer-BioNTech COVID-19 vaccines at an elementary school vaccination site for children ages 5 to 11.

Enlarge / A health care worker prepares to administer Pfizer-BioNTech COVID-19 vaccines at an elementary school vaccination site for children ages 5 to 11. (credit: Getty | Bloomberg)

Cases of COVID-19 are increasing in children, and they continue to account for an out-sized proportion of infections, according to the latest data compiled by the American Academy of Pediatrics.

The fresh data comes at the start of a holiday week and a new surge in cases, worrying experts that the pandemic—and its impact on children—will only worsen as the country heads into the winter months. Travel during this week will likely rival pre-pandemic levels, according to estimates by AAA and the Transportation Security Administration. And many families are anxious to resume holiday traditions and packed family gatherings, in which unvaccinated children are at risk of getting and transmitting the virus.

In the week of November 11 to 18, nearly 142,000 children reported getting COVID-19. That’s an increase of 32 percent from two weeks ago. Overall, cases of COVID-19 in the US have increased 27 percent in the past two weeks.

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#children, #coronavirus, #covid-19, #infection, #pandemic, #public-health, #science, #vaccine

Boosters for all is critical, not a luxury, Fauci says as FDA decision nears

A white-haired man in a face mask.

Enlarge (credit: Getty | Chip Somodevilla)

The Food and Drug Administration is expected to authorize booster doses of the Pfizer-BioNTech COVID-19 vaccine for all adults as early as Thursday, agency insiders told The New York Times Tuesday.

The reported timeline is remarkably fast-paced for the regulatory agency and comes as members of the Biden administration continue to suggest widespread boosting is necessary to bring the COVID-19 pandemic under control.

“I believe… that when we look back on this, we will see that boosters are likely a very critical part of the immunization regimen and not a bonus or a luxury,” top infectious disease expert Anthony Fauci told Reuters on Tuesday.

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White House hails vaccine mandates as number of unvaccinated drops 40%

FLORIDA, 11/09/2021: A boy gives a nurse a high-five before receiving a shot of the Pfizer COVID-19 vaccine at a vaccination site for children aged 5 to 11.

Enlarge / FLORIDA, 11/09/2021: A boy gives a nurse a high-five before receiving a shot of the Pfizer COVID-19 vaccine at a vaccination site for children aged 5 to 11. (credit: Getty | SOPA images)

The White House touted the success of COVID-19 vaccine mandates Wednesday as more of the country’s unvaccinated are rolling up their sleeves.

In the last seven days, the country has averaged 300,000 first doses per day, White House COVID-19 response coordinator Jeff Zients noted in a press briefing today. The weekly total is the highest in nearly a month, Zients added.

Overall, the number of unvaccinated people eligible for a COVID-19 vaccine (people ages 12 and up) has dropped 40 percent since July. That is, the number of unvaccinated fell from about 100 million to less than 60 million.

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#biden, #boosters, #children, #coronavirus, #covid-19, #infectious-disease, #mandate, #public-health, #science, #vaccination, #vaccine

Rodgers is wrong—NFL says league docs never talked to him about vaccine

Quarterback Aaron Rodgers of the Green Bay Packers trots off the field following the NFL game at State Farm Stadium on October 28, 2021, in Glendale, Arizona.

Enlarge / Quarterback Aaron Rodgers of the Green Bay Packers trots off the field following the NFL game at State Farm Stadium on October 28, 2021, in Glendale, Arizona. (credit: Getty | Christian Petersen)

Fallout continues for NFL MVP Aaron Rodgers, who tossed out a smorgasbord of COVID-19 vaccine misinformation and nearly every line from the 2021 anti-vaccine playbook in the course of a single 45-minute interview Friday.

Since then, the Green Bay Packers’ quarterback has lost his position as a spokesperson for Wisconsin-based healthcare organization Prevea Health. Insurance giant State Farm has also significantly cut back on ads that include him. And, now, the NFL is disputing his claim that league doctors provided him with bunk vaccine information.

Rodgers—who is unvaccinated and tested positive for COVID-19 last week—appeared on the The Pat McAfee Show Friday afternoon to address the growing scandal around his vaccination status. He also took the opportunity to rail against COVID-19 vaccines, NFL health policies, and the “woke mob.”

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#aaron-rodgers, #covid-19, #misinformation, #nfl, #science, #vaccine