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, Pfizer vaccines for under 5s overwhelmingly endorsed by FDA advisors

A woman in protective gear leans over a toddler in a bed.

Enlarge / Boston Medical Center Child Life Specialist Karlie Bittrich sees to a baby while in a pediatrics tent set up outside of Boston Medical Center in Boston on April 29, 2020. (credit: Getty | Boston Globe)

A committee of experts advising the Food and Drug Administration voiced unanimous support Wednesday for the authorization of two COVID-19 vaccines for children under the age of 5. If the FDA authorizes the vaccines, it will mark the first time during the more than two-year pandemic that vaccines against COVID-19 will be available for this age group—the last group yet to be eligible for vaccination.

Although children in this young age group have a relatively lower risk of severe disease and death from COVID-19 compared with older groups, they can and do become severely ill and die from the infection. As of last month, 45,000 children under 5 have been hospitalized for COVID-19 during the pandemic; roughly 50 percent of those hospitalizations occurred during the omicron wave. Of the children who land in the hospital, about 63 percent have no underlying medical conditions that put them at greater risk of severe COVID-19. And about a quarter of those hospitalized require intensive care.

So far, 475 children under the age of 5 have died from COVID-19 during the pandemic, making COVID-19 far deadlier than other diseases we routinely vaccinate young children against, including influenza, measles, chickenpox, hepatitis A, and rotavirus.

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Pfizer warns of “constant waves” of COVID as complacency grows

A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020.

Enlarge / A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020. (credit: Getty | KENA BETANCUR )

Growing complacency about COVID-19 and politicization of the pandemic response will cost lives as the world is hit by new waves of the virus in the coming months, Pfizer’s chief executive has warned.

Albert Bourla said people were growing “tired” of the measures introduced to slow the spread of the virus, while “politicians want to claim victory.” Compliance with authorities’ requests for people to get booster shots would fall even among those who are already vaccinated, he predicted.

This, combined with waning immunity from previous infections and vaccinations, was likely to lead to “constant waves” of COVID variants and deaths, he said.

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Pfizer says 3-dose COVID vaccine for under 5s produces strong immune response

Vials of the Pfizer COVID-19 vaccine.

Enlarge / Vials of the Pfizer COVID-19 vaccine. (credit: SOPA images)

Pfizer and BioNTech will request authorization from the US Food and Drug Administration this week for their three-dose COVID-19 vaccine for children ages 6 months to under 5 years, the companies announced this morning.

Top-line clinical trial results indicate that the vaccine series is safe and produces a strong immune response against the pandemic virus, according to the companies.

“The study suggests that a low 3-[microgram] dose of our vaccine…  provides young children with a high level of protection against the recent COVID-19 strains,” BioNTech CEO Ugur Sahin said in a statement.

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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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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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Pfizer, Moderna vaccines aren’t the same; study finds antibody differences

A vial of COMIRNATY (Pfizer/BioNTech) and a vial of Moderna COVID-19 vaccines.

Enlarge / A vial of COMIRNATY (Pfizer/BioNTech) and a vial of Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo)

The mRNA-based COVID-19 vaccines made by Pfizer/BioNTech and Moderna have proven highly effective at priming our immune systems to fight the pandemic coronavirus—preventing substantial amounts of infection, severe disease, and death throughout several waves of variants. But, despite their similar design and efficacy, the two vaccines are not exactly the same—and our immune systems don’t respond to them in the same way.

An early hint of this was some real-world data that found startling differences in the effectiveness of the two vaccines, despite both shots performing nearly identically in Phase III clinical trials—95 percent and 94 percent. Amid last year’s delta wave, a Mayo Clinic study found that Pfizer’s effectiveness against infection dipped to 42 percent while Moderna’s only fell to 76 percent.

According to a new study in Science Translational Medicine, such differences might be explained by evidence that the two vaccines spur the immune system to produce slightly different antibodies against SARS-CoV-2.

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With a second booster now authorized for some, the question is when to get it

A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.

Enlarge / A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021. (credit: Getty | Bloomberg)

The US Food and Drug Administration on Tuesday announced the authorization of second booster doses of both the Pfizer/BioNTech and Moderna COVID-19 vaccines for people ages 50 and above, as well as certain immunocompromised people.

The FDA’s decision, which was made without consulting its panel of independent expert advisers, was expected this week.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, the FDA’s top vaccine regulator, said in a statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”

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Russians are panic-buying medicines amid Western sanctions, boycotts

A woman wearing a face mask leaves a pharmacy in the town of Podolsk some 40 kilometers outside Moscow on November 12, 2021.

Enlarge / A woman wearing a face mask leaves a pharmacy in the town of Podolsk some 40 kilometers outside Moscow on November 12, 2021. (credit: Getty | YURI KADOBNOV )

As Western countries continue to ratchet up sanctions and boycotts against Russia, the country’s citizens are panic-buying medicines, such as antidepressants, sleeping pills, and contraceptives, according to Reuters.

Between February 28 and March 13, Russians bought 270.5 million pharmaceutical items worth about $104 billion, according to sales data compiled for the Russian business newspaper Vedomosti. That two weeks’ worth of buying was comparable to what Russians bought at pharmacies for the entire month of January, which saw purchases of 280 million pharmaceutical items worth about $100 billion.

The analysis, carried out by Russian analytics company DSM Group, found that demand increased sharply for medicines, including antidepressants, sleeping pills, insulin, cancer and heart drugs, hormones, and contraceptives.

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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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Pfizer CEO pushes for fourth shots as anxiety over BA.2 subvariant rises

A man in an open-collared suit addresses a woman in a matching chair.

Enlarge / Pfizer Chairman and CEO Dr. Albert Bourla speaks onstage at the 2022 SXSW Conference at JW Marriott Austin on March 14, 2022 in Austin. (credit: Getty | Chris Saucedo)

While US health experts closely monitor upticks of COVID-19 cases in Europe as well as the global rise of the omicron subvariant BA.2, Pfizer is renewing calls for fourth doses of COVID-19 vaccine.

In an interview Sunday on CBS’ Face the Nation, Pfizer CEO Albert Bourla said that a fourth dose—aka a second booster—is “necessary.”

“The protection what we are getting from the third [doses], it is good enough—actually, quite good for hospitalizations and deaths,” Dr. Bourla said. But, “it’s not that good against infections” with omicron, and “it doesn’t last very long.” He reported that Pfizer is “working very diligently” to come up with a new dose that will protect against all variants and provide longer-lasting protection.

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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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Pfizer and Moderna expect seasonal booster shots after omicron wave

EINDHOVEN, NETHERLANDS - 2022/01/08: A vial containing Moderna COVID-19 booster vaccine at a vaccination centre.

Enlarge / EINDHOVEN, NETHERLANDS – 2022/01/08: A vial containing Moderna COVID-19 booster vaccine at a vaccination centre. (credit: Getty | SOPA Images)

As the US weathers record COVID-19 cases from the ultra-transmissible omicron variant, vaccine makers are thinking about future waves—and the shots that could help prevent them.

Leading mRNA vaccine makers Moderna and Pfizer/BioNTech are currently working up omicron-specific versions of their vaccines, which could be ready in a matter of months. And according to recent interviews, they expect that such boosters will be used as annual shots, which could be given in the fall for the next several years until global transmission dies down.

“I think the reality is that this is going to become an annual vaccination, at least for a period of time,” Scott Gottlieb, former Food and Drug Administration commissioner and Pfizer board member, said Sunday on CBS’s Face the Nation. “We don’t know what the epidemiology of this infection is going to be over the long run, but certainly over the next couple of years, you can envision boosters becoming an annual affair.”

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FDA authorizes booster doses for 12- to 15-year-olds, shortens interval for adults

A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.

Enlarge / A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021. (credit: Getty | Bloomberg)

As the ultra-transmissible omicron coronavirus variant bears down on the US, the Food and Drug Administration on Monday announced a set of sweeping changes to the availability of Pfizer-BioNTech booster doses.

The regulator expanded access to third doses by authorizing their use for kids 12 to 15 years old. The agency also shortened the interval at which adults and children 12 and up can get a booster after their second dose—moving the time from six months to only five months. Last, the FDA made third doses available to immunocompromised children ages 5 to 11 who may not mount a strong response from only the first two doses.

The FDA’s moves are motivated by omicron and backed by data from Israel, which has a booster program further along than that of the US. In fact, Israeli officials on Monday began offering fourth doses (second booster doses) of the Pfizer-BioNTech vaccine to people ages 60 and over in an effort to sustain high levels of protection in the population. The omicron variant, which is currently powering a vertical rise in cases in the US, has been found to thwart protection from only two vaccine doses, but it can still be defeated with booster doses.

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FDA gives emergency authorization to Pfizer’s COVID-19 pill

FDA gives emergency authorization to Pfizer’s COVID-19 pill

Enlarge

COVID-19 patients as young as 12 can now be treated with Paxlovid, an antiviral pill developed by Pfizer, after the Food and Drug Administration issued an emergency use authorization on Wednesday. 

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.” 

In early November, Pfizer published trial results for the new oral medication, saying that it reduced hospitalizations and deaths due to COVID-19 by 89 percent. Although the results had not undergone peer-review, Paxlovid’s strong effectiveness moved an independent data-monitoring committee to recommend ending the trial early.

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Pfizer’s anti-COVID drug still looks effective after further analysis

Scenes like this might become less common if a new SARS-CoV-2 protease inhibitor becomes widely available.

Enlarge / Scenes like this might become less common if a new SARS-CoV-2 protease inhibitor becomes widely available. (credit: Getty Images)

On Monday, pharmaceutical giant Pfizer released more data on its anti-COVID-19 drug, named Paxlovid. The company had released its initial data on the drug in early November, and it looked extremely promising: a drop in hospitalization and death of 89 percent in high-risk patients. But preliminary results like that don’t always hold up, as we saw with a drug from Merck. But there’s good news in this case: Paxlovid appears to be just as effective once more patients and numbers from a second trial are included.

On trial

Paxlovid inhibits a viral protein called a protease, which normally breaks chemical bonds in other viral proteins, converting them into their mature, functional forms. This processing is needed before the virus is able to copy its own genome, so inhibiting the protease should block viral reproduction.

Pfizer started at least two clinical trials with Paxlovid. One involved unvaccinated individuals who are at high risk from COVID-19 due to age or health issues. The second trial involved moderate risks: either unvaccinated individuals with no risk factors, or those who have been vaccinated but are at elevated risk. In both trials, treatments started within days of a confirmed infection.

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FDA authorizes Pfizer and Moderna COVID boosters for all adults

19 November 2021, Hamburg: A tray of prepared syringes for booster vaccinations with Moderna's vaccine.

Enlarge / 19 November 2021, Hamburg: A tray of prepared syringes for booster vaccinations with Moderna’s vaccine. (credit: Getty | Picture alliance)

The Food and Drug Administration has authorized booster doses of both the Pfizer-BioNTech and Moderna COVID-19 vaccines for all people ages 18 and up, the companies announced separately this morning.

The boosters are to be given at least six months after a person’s second dose and, according to Moderna, can be used for mix-and-match boosting. That is, people who received two Pfizer-BioNTech vaccine doses earlier this year could get a Moderna booster and vice versa.

Preliminary data released last month from a mix-and-match booster trial run by the National Institutes of Health found that Moderna boosters appeared to generate the highest antibody levels overall, including in people who had previously received two doses of the Pfizer-BioNTech vaccine. However, the trial used a full dose of the Moderna vaccine (100 micrograms) for a booster, whereas the FDA has authorized a half-dose shot (50 micrograms) for boosters. It’s unclear if the half dose offers the same edge over boosting with a third Pfizer-BioNTech shot, which is given at the same dosage as the first two shots (30 micrograms).

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Pfizer says its antiviral pill can cut 89% of COVID hospitalizations and deaths

Pfizer headquarters in Manhattan on November 19, 2020.

Enlarge / Pfizer headquarters in Manhattan on November 19, 2020. (credit: Getty | Anadolu Agency)

An antiviral pill developed by Pfizer reduced COVID-19 hospitalizations and deaths by about 89 percent in a trial involving 774 newly infected people at risk of developing severe disease. That’s according to a press release posted Friday by the company; the full data has not yet been released, published, or peer-reviewed.

Still, Pfizer said the results looked promising enough that an independent data-monitoring committee recommended the trial end early. Pfizer said it now plans to submit its data as soon as possible to the Food and Drug Administration for an Emergency Use Authorization (EUA).

Pfizer’s oral antiviral—PF-07321332—is the second drug candidate to generate buzz as an easy-to-use and highly effective COVID-19 treatment. Last month, Merck announced that its oral antiviral treatment, molnupiravir, cut the risk of hospitalization and death from COVID-19 by roughly 50 percent in newly infected, at-risk people. Merck has applied for an EUA, and FDA advisers will review the application on November 30.

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Wealthy families, encouraged by Henry Kissinger’s lawyer, sank over $400M into Theranos

Theranos founder Elizabeth Holmes speaks on stage during the closing session of the Clinton Global Initiative 2015 on September 29, 2015, in New York City.

Enlarge / Theranos founder Elizabeth Holmes speaks on stage during the closing session of the Clinton Global Initiative 2015 on September 29, 2015, in New York City. (credit: JP Yim/Getty Images)

Silicon Valley loves unicorns, the privately held startups that surge to $1 billion valuations and beyond. By that measure, Theranos was a very special breed of unicorn—not only was the company worth several billion dollars, but it also raised around $1 billion from investors alone. Finding that kind of money can be challenging, but thanks to one well-connected matchmaker, Theranos made it look almost easy.

In the criminal trial of Theranos founder Elizabeth Holmes, the jury heard that the matchmaker was Daniel Mosley, the estate attorney for former secretary of state and Theranos board member Henry Kissinger. In less than two years, Mosley connected several wealthy families and individuals with Theranos, ultimately bringing it over $400 million in investments, a significant portion of the estimated $900 million to $1.3 billion that the startup raised over its lifetime.

The list of Mosley-introduced investors, most of them his clients, reads like a who’s who list of the rich and powerful. The DeVos family, which made its money from founding Amway, put in $100 million, as did the Cox family, which controls Cox Enterprises, a media, telecom, and automotive conglomerate. The Walton family of Walmart fame invested $150 million, while Andreas Dracopoulos, a Greek shipping heir, put up $25 million. Kissinger himself was good for $3 million, and Mosley for $6 million. Kissinger’s friends who were not Mosley’s clients, including the Oppenheimer family (which formerly controlled the diamond miner DeBeers), invested another $24 million.

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FDA authorizes Pfizer COVID-19 vaccine for children 5-11

FDA authorizes Pfizer COVID-19 vaccine for children 5-11

Enlarge (credit: Getty | Congressional Quarterly)

The Food and Drug Administration has issued an emergency authorization for the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11.

The FDA’s authorization follows the recommendation of its independent advisory committee, which earlier this week voted nearly unanimously in favor of authorizing the vaccine. The committee of 18 voting members voted 18 to 0 in favor, with one abstention.

In a day-long meeting Tuesday, advisors pored over data and analyses of the vaccine in the younger children, who will receive two shots of a 10-microgram dose—a third of the dosage used in people ages 12 years and up—three weeks apart. Data from clinical trials suggest that the smaller dose in children produces equally strong immune responses as those seen in older age groups while minimizing the risks of side effects.

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Kid COVID-19 vaccines get green light from FDA advisors

A nurse gives a boy a dose of the Pfizer vaccine at a COVID-19 vaccine clinic in Florida on the day before classes begin for the 2021-22 school year.

Enlarge / A nurse gives a boy a dose of the Pfizer vaccine at a COVID-19 vaccine clinic in Florida on the day before classes begin for the 2021-22 school year. (credit: Getty | Paul Hennessy)

A panel of independent medical experts advising the Food and Drug Administration voted 17 to 0 (with one abstention) this afternoon in favor of authorizing the Pfizer-BioNTech COVID-19 vaccine for use in children ages 5 to 11 years old.

The vote is a key step toward the first pediatric COVID-19 vaccine in the US. Next, the FDA will need to sign off on the recommendation from the advisory panel—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—and issue an emergency use authorization for the 5-to-11 age group. That FDA’s authorization is expected within days. Once that occurs, the federal government will begin shipping pediatric doses of the vaccine to states for distribution at clinics, pharmacies, and pediatricians’ offices.

But before doses can go into any little arms, a panel of independent experts for the Centers for Disease Control and Prevention will also need to weigh in. That panel—the Advisory Committee on Immunization Practices (ACIP)—is scheduled to meet November 2 and 3. If ACIP votes in favor of recommending use of the vaccine in children ages 5 to 11, CDC Director Rochelle Walensky will need to sign off on the committee’s recommendation. That would likely happen quickly, and after that, vaccinations can begin.

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COVID vaccines for kids 5-11 up for preorder Wednesday ahead of FDA review

A thirteen-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

Enlarge / A thirteen-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021. (credit: Getty | JOSEPH PREZIOSO )

Starting tomorrow, October 20, states and other jurisdictions will be able to preorder doses of the Pfizer-BioNTech COVID-19 vaccine formulated for children ages 5 to 11, according to a federal planning document. The orders are in anticipation of a rollout that could begin as early as November 3.

The vaccine is not yet authorized by the Food and Drug Administration, and the Centers for Disease Control and Prevention has not yet given the green light for its administration. But US officials are wasting no time in preparing to vaccinate as many children as possible as quickly as possible. There are an estimated 28 million children in the US between the ages of 5 to 11, and the US government says it has enough vaccine doses for all of them. Vaccine doses are planned to roll out at pediatricians’ offices, pharmacies, health centers, and rural clinics when the time comes.

The Pfizer-BioNTech vaccine is currently available for people ages 12 and up. In late September, Pfizer and BioNTech submitted data to the FDA indicating that small doses of their vaccine—a third of the dose used for adults—could safely and robustly protect children ages 5 to 11 from COVID-19. On October 7, the companies formally requested that the FDA grant an Emergency Use Authorization (EUA) for the use of their vaccine in those youngsters.

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#5-11-year-old, #biontech, #cdc, #children, #covid-19, #fda, #infectious-disease, #pfizer, #public-health, #science, #vaccine

FDA advisors unanimously green-light Moderna boosters for people 65+, high-risk

Words and symbols adorn a large outdoor sign.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

As expected, a committee of independent advisors for the Food and Drug Administration voted unanimously (19-to-0) Thursday afternoon in favor of authorizing a booster dose of Moderna’s COVID-19 vaccine for certain groups.

The groups flagged for boosting are individuals aged 65 and older, people ages 18 to 64 who are at risk of severe COVID-19 due to health concerns, and those 18 to 64 who are at risk of COVID-19 due to frequent institutional or occupational exposures, such as health care and essential workers. These are the same groups that were previously authorized to get a Pfizer/BioNTech booster.

As with the Pfizer/BioNTech boosters, the Moderna boosters are to be given six months or longer after the first two doses of Moderna’s mRNA vaccine.

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#biontech, #booster, #covid-19, #fda, #infectious-disease, #johnson-johnson, #moderna, #pfizer, #public-health, #sars-cov-2, #science, #vaccine, #vaccine-efficacy

Mix-and-match COVID boosters are as good—if not better than—all the same shots

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)

Mixing and matching COVID-19 vaccines for booster doses appears safe and as effective—if not more effective—than sticking with the same vaccine for a booster dose. That’s according to preliminary data posted online Wednesday from a clinical trial run by the National Institutes of Health.

The trial bolsters what some have long hoped: that mixing and matching vaccines could provide stronger, broader protection against the pandemic virus and all its variants.

The trial was not large enough to definitively indicate which combination of vaccines offers the best protection. And the early results, available on a preprint server, have not yet been peer-reviewed. But the preliminary trial findings do hint that Moderna’s mRNA vaccine may offer the strongest protection all around—backing up similar findings from earlier vaccine-effectiveness studies. The data also suggests that people who received the one-shot Johnson & Johnson vaccine may want to get a boost with one of the two mRNA vaccines, either Moderna’s or Pfizer/BioNTech’s.

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Biden administration expects J&J boosters in the next few weeks

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)

Johnson & Johnson plans to seek authorization for a booster dose for its one-shot COVID-19 vaccine early this week, according to a report by The New York Times.

J&J is the last to apply for booster authorization among the makers of the three COVID-19 vaccines used in the US. Yet, it is the booster that many health officials are most eager to see. The vaccine, which uses a viral vector strategy rather than an mRNA-based design, is the only available COVID-19 vaccine given as just one shot. Its efficacy has lagged behind the other vaccines throughout the pandemic.

Still, Moderna and Pfizer-BioNTech, both mRNA-based vaccine, have already submitted booster applications to US regulators. On September 22, the Food and Drug Administration granted authorization for a booster dose of the Pfizer-BioNTech vaccine for certain groups of people. The decision was tense, with experts torn over whether a booster for the highly effective vaccine was widely needed.

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CDC director overrules experts, allows Pfizer boosters for health workers

CDC Director Rochelle Walensky testifies during a Senate committee hearing in July 2021.

Enlarge / CDC Director Rochelle Walensky testifies during a Senate committee hearing in July 2021. (credit: Stefani Reynolds-Pool/Getty Images)

Just past midnight last night, the director of the Centers for Disease Control and Prevention overruled a committee of independent advisers, allowing for use of a Pfizer/BioNTech vaccine booster dose in people with increased risk of occupational and institutional exposure to the pandemic coronavirus. That includes health care workers, front-line workers, teachers, day care providers, grocery store workers, and people who work or live in prisons and homeless shelters, among others.

Hours earlier, the CDC’s Advisory Committee on Immunization Practices (ACIP) concluded a two-day meeting on booster recommendations—and voted 9-6 against recommending boosters for this group.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Director Rochelle Walensky said in a statement. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

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Following expert advice, FDA authorizes boosters for people 65+, high risk

Words and symbols adorn a large outdoor sign.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

The US Food and Drug Administration late Wednesday authorized booster doses of the Pfizer/BioNTech COVID-19 vaccine for people ages 65 and up. Also eligible for boosters will be those ages 18 to 64 who are at high risk of severe COVID-19 or at high risk from frequent occupational or institutional exposures to SARS-CoV-2, such as healthcare workers and teachers.

The single booster dose should only be given at least six months after the two initial doses. The approval comes an amendment to an Emergency Use Authorization.

The FDA’s authorization largely follows the recommendations from a committee of independent experts that advises the agency, known as the Vaccines and Related Biological Products Advisory Committee or VRBPAC. The committee met all day Friday to review and deliberate over the data surrounding boosters. The meeting concluded with an 18-0 vote in favor of recommending boosters for people over 65 and high-risk groups. But, prior to that, the committee voted 16-2 against recommending boosters for everyone ages 16 and up, rejecting the Biden administration’s plans to rollout additional doses to nearly all vaccinated people.

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Kids 5-11 appear safely protected by small doses of COVID vaccine, Pfizer says

Vials of the Pfizer COVID-19 vaccine.

Enlarge / Vials of the Pfizer COVID-19 vaccine. (credit: SOPA images)

Small doses of Pfizer’s COVID-19 mRNA vaccine in children ages 5 to 11 appeared to produce strong antibody responses and comparable side effects to those seen in older age groups, according to the first top-line results from a Phase 2/3 clinical trial released by Pfizer and its partner BioNTech early Monday.

The trial data involved 2,268 children ages 5 to 11 years, and these children were given a series of two 10-microgram doses of the vaccine, 21 days apart. The dosage is just a third of the 30-microgram doses given to people ages 12 and above.

One month after the second dose, researchers measured the children’s levels of antibodies able to neutralize SARS-CoV-2 virus in a lab experiment. The geometric mean titer of antibody in the 5 to 11 year olds was 1,197.6 (95 percent confidence interval of 1,106.1 to 1,296.6), which is comparable to the geometric mean titer of 1,146.5 seen in people ages 16 to 25.

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#covid-19, #covid-19-vaccines, #fda, #infectious-diseases, #pfizer, #science

Vaccine mandates work, especially when they’re done right

Vaccine mandates work, especially when they’re done right

Enlarge (credit: Mario Tama | Getty Images)

On Monday, the US Food and Drug Administration gave formal, full approval to the Covid-19 vaccine made by the drug companies Pfizer and BioNTech. You might’ve already gotten a dose of it, of course; millions of Americans have, thanks to an “emergency use authorizationawarded in December 2020. But the new designation was more than just a formality. “If you’re one of the millions of Americans who said they will not get the shot until it has full and final approval from the FDA, it has now happened,” President Joe Biden said when he announced the approval. And, in the same speech: “If you’re a business leader, a non-profit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that—require it.”

Pretty much right away, a lot of places did. Vaccines are safe, effective, and free, but somewhere around 30 percent of Americans haven’t got their shots. Carrots didn’t work; here come the sticks. And they might be able to crush the fourth wave of the Covid pandemic in the US—if they’re done right.

Like the other vaccines still available under EUA, the Pfizer drug is extraordinarily good at keeping people from getting really sick or dying from Covid. But with more than 100,000 people in the hospital with Covid in the US—the most since January—and with the vast majority of them unvaccinated, it’s clear that alone isn’t enough. States, localities, and businesses have tried inducements like prizes, cash, or lotteries, little tricks designed to corral people into doing what’s good for them. In the language of behavioral economics, that’s called a nudge. But in states with low vaccine uptake, those nudges didn’t change the momentum. So now, it’s time for mandates. If you’re one of the 30 percent or so of Americans who haven’t gotten vaccinated yet, get ready for a good hard shove.

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#covid-19, #mandates, #moderna, #pfizer, #science, #vaccines

Pediatricians push for speedy COVID vaccines for kids—but no jumping the gun

A kid gets a cotton swab shoved up his nose.

Enlarge / PALOS VERDES ESTATES, CA – AUGUST 24: A father helps his 4-year-old son with the swab for a rapid COVID-19 test. (credit: Getty | MediaNews Group)

After Pfizer’s COVID-19 vaccine earned full regulatory approval Monday, pressure is mounting to have the vaccine available to children under 12 years old—and so are concerns that it will be given to them prematurely.

The approval from the Food and Drug Administration covers use of the vaccine in people ages 16 and up, while the agency’s Emergency Use Authorization still allows for its use in adolescents between the ages of 12 and 15. Some experts expect the FDA will grant full approval for use in 12- to 15-year-olds relatively soon.

But many parents and pediatricians are most eager for the green light to offer the vaccine to children under 12. Vaccinating young children has become a particularly pressing issue with the wild spread of the hypertransmissible delta variant, new school terms beginning, disputes over masks, and big holidays just around the corner. In a letter sent to the FDA earlier this month, the American Academy of Pediatrics urged the agency to authorize the vaccine for children under 12 “as swiftly as possible.”

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FDA fully approves Pfizer-BioNTech’s COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine to achieve that status. The mRNA-based vaccine has been available since late last year through an Emergency Use Authorization (EUA), and will continue to be offered under that designation for those aged 12 to 15 until that separate approval process goes through, but the U.S. drug regulator now recognizes the Pfizer vaccine as fully approved and certified for adults 16 and up.

Part of receiving the approval means that Pfizer and BioNTech can now officially market their vaccine in the U.S., and the FDA revealed it’ll be offered under the trade dress ‘Comirnarty,’ which doesn’t strike me as particularly catchy but at least it’s less of a mouthful than ‘the Pfizer-BioNTech COVID-19 vaccine.’ FDA approval also means that the vaccine has met all of the administration’s standards for safety and efficacy, including preclinical and clinical trial data, as well as information about tits manufacture, and data gathered from its use during the EUA period.

There’s hope that this new full authorization will encourage fence-sitters who have offered up ‘I’ll wait until it’s fully approved’ as an excuse for not yet having gotten the vaccine despite its availability. At the very least, it’s going to be a lot harder for those hesitating to justify their unreasonable and irresponsible stance in the face of the ongoing pandemic.

Comirnarty got flagged for ‘Priority Review’ by the FDA, which essentially means that the administration devoted its full attention to the process in order to expedite it. No word yet on a timeline for Moderna’s approval, but it’s also in the priority review queue.

We’ll be talking to BioNTech CEO and co-founder Uğur Şahin at TC Disrupt 2021 this year, so be sure to check out that virtual event coming up September 21-23.

#biontech, #biotech, #covid-19, #pfizer, #tc, #vaccine

FDA approves Pfizer’s COVID-19 vaccine, now called Comirnaty

Empty Pfizer-BioNTech COVID-19 vaccine vials

Enlarge / Empty Pfizer-BioNTech COVID-19 vaccine vials (credit: AHMAD GHARABLI)

The Food and Drug Administration has granted full approval of the Pfizer/BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty (koe-mir’-na-tee), the agency announced Monday.

The vaccine’s full approval—or Biologics License Application (BLA)—applies for use of a two-dose regimen, given three weeks apart, in people ages 16 years and older. It is the first BLA to be issued for a vaccine against COVID-19. The vaccine will still be available under an Emergency Use Authorization (EUA) for adolescents ages 12 to 15 and for use as a third booster dose in certain people with compromised immune systems.

The name Comirnaty—already in use elsewhere, including Europe—is a mash-up of “COVID-19 immunity” and “mRNA” that is meant to evoke the word “community.”

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Report: Pfizer’s COVID-19 vaccine may get full FDA approval Monday

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The Food and Drug Administration is aiming to issue full regulatory approval of Pfizer/BioNTech’s COVID-19 vaccine as early as Monday, according to a report by the New York Times.

The regulatory agency had previously set an unofficial internal goal for issuing the approval by early September. Officials who spoke with the Times said that FDA officials were working to finish the approval Friday, but they were still going through paperwork and negotiations with the companies. The timeline could still slip past Monday if the process takes longer than expected, but the agency is on track to grant approval as early as next week, Politico reported.

Currently the Pfizer/BioNTech two-dose mRNA vaccine is being offered in the US based on an Emergency Use Authorization. So far, 200 million doses have been administered in the US alone. Though the vaccine has proven highly effective and safe, the full approval may convince some vaccine holdouts that the shot is, indeed, safe and effective. Previous polling by the Kaiser Family Foundation found that 31 percent of unvaccinated people would be more likely to get their shots if a vaccine earned full approval.

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#approval, #bla, #covid-19-vaccine, #fda, #pfizer, #science, #vaccine

What to know about the US COVID booster plan—and why WHO hates it

 A health professional holds a vial of the Moderna vaccine against Covid-19

Enlarge / A health professional holds a vial of the Moderna vaccine against Covid-19 (credit: Europa Press News)

US officials on Wednesday formally announced plans to offer COVID-19 vaccine booster shots to Americans—and the plans are already under fire from experts at the World Health Organization.

US officials are recommending that all Americans vaccinated with two doses of an mRNA vaccine (either the Moderna or Pfizer/BioNTech vaccine) get a third booster dose of the same vaccine eight months after receiving their second dose. As such, boosters will be rolled out based on the order in which people were initially offered vaccines, i.e., with frontline health workers, nursing home residents, and other seniors at the front of the line.

US officials are prepared to begin offering booster shots the week of September 20. However, the timing of the boosters is pending authorization from the Food and Drug Administration and the recommendation of the Advisory Committee on Immunization Practices, an independent committee of experts that advises the Centers for Disease Control and Prevention.

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Here’s who can get a 3rd vaccine dose now—and who may be next

Hypodermic needles lined up in a tray.

Enlarge / COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021. (credit: Getty | NurPhoto)

Pfizer and BioNTech submitted new COVID-19 vaccine-booster data to the Food and Drug Administration Monday as US officials continue to consider whether to recommend third doses for more Americans.

For now, officials have only recommended that some people with weakened immune systems get a third dose of a COVID-19 vaccine. While officials continue to say that there is not enough evidence to support third-dose boosters for other vaccinated groups at this point, many officials say boosters will likely be in our futures. The lingering questions are when exactly shots will be needed and who will be next in line.

On Sunday, Director of the National Institutes of Health Francis Collins told the Associated Press that, with the delta variant raging and immune responses possibly waning, officials could be making decisions on boosters for this fall or winter within the coming weeks.

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FDA expected to authorize 3rd COVID vaccine dose for immunocompromised

Extreme close-up photograph of gloved hand holding frost-covered glass vial.

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

The Food and Drug Administration is expected to announce Thursday (or soon after) that it is authorizing a third COVID-19 vaccine dose for some people with compromised immune systems, according to people familiar with the FDA’s plans.

The plans were first reported by NBC News and confirmed by CNN and Politico.

The FDA is expected to give a green light for a third dose of both the Moderna and Pfizer/BioNTech mRNA vaccines. The authorization for the third shots would come by way of updates to the vaccines’ emergency use authorizations.

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BioNTech founder Uğur Şahin and Mayfield’s Ursheet Parikh are coming to Disrupt

It’s hard to argue that any technology company has had a greater impact in the past decade than BioNTech, the mRNA-based therapeutics pioneer behind the world’s most widely-used COVID-19 vaccine. Developed in record time in partnership with Pfizer, thanks to an existing partnership to work on immunization for the common flu, BioNTech’s mRNA inoculation is without a doubt one of the biggest medical innovations of the past century.

BioNTech co-founder and CEO Uğur Şahin isn’t stopping there, of course: the company recently announced that it would be developing an mRNA-based vaccine targeting malaria, an illness that still kills more than 400,000 people per year. It also has treatments for a range of cancers in process in its development pipeline, and has announced plans to address HIV and tuberculosis with future candidates.

This year at Disrupt 2021, Şahin will join us along with Mayfield Fund Partner Ursheet Parikh, a key investor in BioNTech. Both Şahin and Parikh will be talking to us about how the COVID-19 vaccine came to be, but more importantly, about what the future holds for mRNA technology and its potential to address a wide range of chronic healthcare problems that have been tough challenges to solve for decades or even centuries. We’ll also be talking about what it means to build a biotech startup with true platform potential, and how that might differ now as compared to what investors were looking for just a few short years ago.

Şahin and Parikh are just two of the many high-profile speakers who will be on our Disrupt Stage and the Extra Crunch Stage. During the three-day event, writer, director, actor and Houseplant co-founder Seth Rogen will be joined by Houseplant Chief Commercial Officer Haneen Davies and co-founder and CEO Michael Mohr to talk about the business of weed, Secretary of Transportation Pete Buttigieg will talk about the future of getting around and the government’s role in partnering with startups, and Coinbase CEO Brian Armstrong will dig into the volatile world of cryptocurrency and his company’s massive direct listing earlier this year.

Disrupt 2021 wouldn’t be complete without Startup Battlefield, the competition that launched some of the world’s biggest tech companies, including Cloudflare and Dropbox. Join Secretary Buttigieg and over 10,000 of the startup world’s most influential people at Disrupt 2021 online this September 21-23. Check out the Disrupt 2021 agenda. We’ll add even more speakers.

Buy your Disrupt pass before July 30 at 11:59 pm (PT), and get ready to join the big, bold and influential — for less than $100.

Get your pass to attend now for under $99 for a limited time!

#articles, #biontech, #brian-armstrong, #ceo, #clinical-trials, #cloudflare, #coinbase, #dropbox, #events, #hiv, #illness, #life-sciences, #malaria, #mayfield-fund, #medical-research, #pete-buttigieg, #pfizer, #secretary, #tc, #tc-disrupt, #tc-disrupt-2021, #technology, #ugur-sahin, #ursheet-parikh

Early bird savings on passes to TechCrunch Disrupt 2021 end this week

Tick tock, early-stage startup fans: If you plan to attend TechCrunch Disrupt 2021 (September 21-23), time is running out to score a pass to the world’s leading conference dedicated to tech startups — for less than $100. The early bird sale ends this week, so buy your pass here before the deal expires on July 30 at 11:59 pm (PT).

And if you’re part of the tech startup ecosystem — or aspire to be — why the heck wouldn’t you dive headlong into three days dedicated to the art and science required to build and scale successful startups? Just listen to what three past attendees said about their Disrupt experience.

Disrupt is a great sweet spot, and highly valuable, for anyone in the idea stage all the way through to having raised some angel money. Soak up the pitch deck teardowns and the VC presentations. They’re telling you what they’re looking for, what motivates them, what pushes them to contact you for a meeting. And that’s exactly what every startup raising capital needs to know. — Michael McCarthy, CEO, Repositax.

“TechCrunch has created a great venue that brings together all the different people within the startup ecosystem. It’s a place where new startups can present, attendees can learn from top industry experts and who knows? One day they might be the person speaking on the Disrupt stage. It’s a great event overall.” — JC Bodson, founder and CEO of Arbitrage Technologies

“The connections I made at Disrupt offer long-term benefits. Investors willing to put forth capital, engineers offering tech expertise and manufacturers to help me streamline. Fostering these relationships will help me grow my company and my bottom line.” — Felicia Jackson, inventor and founder of CPRWrap.

Disrupt is the place to be to learn, connect, collaborate and keep tabs on rapidly changing trends. Here’s just one example of the timely topics and world-class experts we have on tap. Don’t forget to check out the agenda.

Saving the World: COVID-19 changed everything. It not only threatened our individual health and wellbeing, but it also shook industries and economies across the globe. The same could be said about the COVID-19 vaccines. Hear from BioNTech Cofounder and CEO, Ugur Sahin on the process of rapidly developing the world’s most sought-after vaccine, alongside Pfizer, and the long-term potential of mRNA-based therapies. Sahin will be joined by Ursheet Parikh of Mayfield Fund to discuss what’s next for startups in this rapidly evolving industry.

Pro Tip: We’ll add new speakers, events and discounts in the run up to Disrupt — sign up for updates so you don’t miss out.

TechCrunch Disrupt 2021 takes place September 21-23, but the time to snag serious savings ends this week. Buy your early bird pass here before the deal expires on July 30 at 11:59 pm (PT).

Is your company interested in sponsoring or exhibiting at Disrupt 2021? Contact our sponsorship sales team by filling out this form.

#biontech, #business, #ceo, #companies, #cprwrap, #economy, #felicia-jackson, #founder, #mayfield-fund, #pfizer, #startup-company, #tc, #techcrunch, #techcrunch-disrupt-2021, #ugur-sahin, #ursheet-parikh, #verizon-media

Industrial cybersecurity startup Claroty raises $140M in pre-IPO funding round

Claroty, an industrial cybersecurity company that helps customers protect and manage their Internet of Things (IoT) and operational technology (OT) assets, has raised $140 million in its latest, and potentially last round of funding. 

With the new round of Series D funding, co-led by Bessemer Venture and 40 North, the company has now amassed a total of $235 million. Additional strategic investors include LG and I Squared Capital’s ISQ Global InfraTech Fund, with all previous investors — Team8, Rockwell Automation, Siemens, and Schneider Electric — also participating. 

Founded in 2015, the late-stage startup focuses on the industrial side of cybersecurity. Its customers include General Motors, Coca-Cola EuroPacific Partners, and Pfizer, with Claroty helping the pharmaceutical firm to secure its COVID-19 vaccine supply chain. Claroty tells TechCrunch it has seen “significant” customer growth over the past 18 months, largely fueled by the pandemic, with 110% year-over-year net new logo growth and 100% customer retention. 

It will use the newly raised funds to meet this rapidly accelerating global demand for The Claroty Platform, an end-to-end solution that provides visibility into industrial networks and combines secure remote access with continuous monitoring for threats and vulnerabilities. 

“Our mission is to drive visibility, continuity, and resiliency in the industrial economy by delivering the most comprehensive solutions that secure all connected devices within the four walls of an industrial site, including all operational technology (OT), Internet of Things (IoT), and industrial IoT (IIoT) assets,” said Claroty CEO Yaniv Vardi.

To meet this growing demand, the startup is planning to expand into new regions and verticals, including transportation government-owned industries, as well as increase its global headcount. The company, which is based in New York, currently has around 240 employees. 

Claroty hasn’t yet made any acquisitions, though CEO Yaniv Vardi tells TechCrunch that this could be part of the startup’s roadmap going forward.

“We’re waiting for the right opportunity at the right time, but it’s definitely part of the plan as part of the financial runway we just secured,” he said, adding that this latest funding round will likely be the company’s last before it explores a potential IPO.

“We are thinking that this is a pre-IPO funding round,” he said. “The end goal here is to be the market leader for industrial cybersecurity. One of the mascots can be going public with an IPO, but there are different options too, such as SPAC.”

The funding round comes amid a sharp increase in cyber targeting organizations that underpin the world’s critical infrastructure and supply chains. According to a recent survey carried out by Claroty, the majority (53%) of US industrial enterprises have seen an increase in cybersecurity threats since the start of 2020. The survey of 1,110 IT and OT security professionals also found that over half believed their organization is now more of a target for cybercriminals, with 67% having seen cybercriminals use new tactics amid the pandemic. 

“The number of attacks, and impact of these attacks, is increasing significantly, especially in verticals like food, automotive, and critical infrastructure. Vardi said. “That creates a lot of risk assessments public companies had to do, and these risks needed to be addressed with a security solution on the industrial side.”

#articles, #ceo, #coca-cola, #computer-security, #computing, #data-security, #food, #funding, #general-motors, #industrial-automation, #industrial-internet-of-things, #internet-of-things, #lg, #new-york, #operational-technology, #pfizer, #pharmaceutical, #siemens, #startup-company, #startups, #team8, #techcrunch, #technology, #united-states

Russia tried to spread dangerous lies about Pfizer vaccine, France suspects

Pointy towers at sunset.

Enlarge / The Kremlin in Moscow, Russia, on Friday, Dec. 11, 2020. (credit: Getty | Bloomberg)

French authorities are investigating whether the Russian government is behind an effort to spread dangerous lies about Pfizer-BioNTech’s COVID-19 vaccine as part of a disinformation campaign peddled to French bloggers and influencers.

In recent days, several French influencers have publicly noted receiving partnership proposals from a dodgy agency, called Fazze, over email or social media. The proposals, written in broken English, offered enticing lumps of money if the influencers spread entirely false claims and doubts about COVID-19 vaccines. Among the proposed claims is the dangerous falsehood that people who received the Pfizer-BioNTech vaccine have a death rate three times higher than those who received the vaccine by AstraZeneca.

French news outlet Numerama obtained a copy of one of the emailed offers, which directed influencers to “Tell that mainstream media ignores this theme and you decided to share it with your subscriber [sic].” The offer also said to “put a question like ‘Why some governments actively purchasing Pfizer vaccine, which is dangerous to health of the people[sic]?’” The offer directed influencers to end their messages by encouraging subscribers to “draw their own conclusions.”

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#antivaccine, #bloggers, #covid-19, #france, #influencers, #pfizer, #russia, #science, #sputnik-v, #vaccine, #vaccine-misinformation

Pfizer’s COVID vaccine can stay in normal fridge for up to a month, FDA says

A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

The US Food and Drug Administration on Wednesday announced a big change in the way doses of Pfizer-BioNTech’s COVID-19 vaccine can be handled. From now on, undiluted vials of the mRNA vaccine can stay at normal refrigerator temperatures for up to a month rather than the previous limit of just five days.

The change has the potential to significantly ease storage issues and promote the use of the highly effective vaccine, which has been hindered in some settings by its ultra-cold storage requirements.

For long-term storage, the vaccine still requires ultra-cold freezer temperatures—between -80°C to -60°C (-112°F to -76°F). But the vials can be transported and temporarily stored at normal freezer temperatures—between -25°C to -15°C (-13°F to 5°F)—for up to two weeks. According to yesterday’s update, the undiluted vials can then be thawed and kept at normal refrigerator temperatures—between 2°C to 8°C (35°F to 46°F)—for up to a month. Once the vials are diluted and ready for use, they must be used within six hours, according to the FDA’s detailed handling guide.

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FDA authorizes Pfizer’s COVID-19 vaccine for 12- to 15-year-olds

An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS)

The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening.

In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.

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AstraZeneca’s troubled vaccine not renewed in EU; Pfizer gets big, new deal

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

“We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters. “We’ll see what happens,” he added, leaving open the possibility of future orders.

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FDA reportedly plans to authorize Pfizer’s COVID vaccine for teens 12-15 in days

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The Food and Drug Administration is planning to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a report by The New York Times.

The Times cited unnamed federal officials who did not have authorization to speak publicly about the FDA’s plans. If the FDA does authorize use of the vaccine in the teen group in the week, the Centers for Disease Control and Prevention’s vaccine advisory panel will likely meet a day later to review the clinical trial data and make a recommendation on use, the Times reported.

On March 31, Pfizer announced that the vaccine completely protected adolescents ages 12 to 15 against COVID-19 in a small Phase III clinical trial. The vaccine was also well-tolerated in the age group, producing mainly standard side effects.

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