Trial started for vaccine against one of the scariest coronavirus 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)

Researchers have given out the first jabs of a tweaked version of Moderna’s COVID-19 vaccine, one aimed at fighting one of the most concerning coronavirus variants—the B.1.351 variant, first identified in South Africa.

The jabs are part of an early trial of the tweaked vaccine, which is being run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The agency aims to enroll around 210 healthy adults in the trial by the end of April.

“The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” NIAID Director Anthony Fauci said in an announcement. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”

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After dramatic rebuke, AstraZeneca lowers vaccine efficacy estimate—a little

A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021.

Enlarge / A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021. (credit: Getty | Gabriel Bouys)

Brushing aside a dramatic rebuke from government researchers and independent experts, AstraZeneca on Wednesday night announced that a new analysis found its COVID-19 vaccine to be 76 percent effective at preventing symptomatic COVID-19—down from the 79 percent efficacy estimate it announced in a press release Monday.

The new estimate is still high, according to an independent board of experts tasked with overseeing the vaccine’s trial and data analysis. The trial’s Data and Safety Monitoring Board (DSMB) sent a highly unusual letter to AstraZeneca soon after the Monday press release, noting that trial data it had seen during February and March meetings suggested that the vaccine’s efficacy was actually between 69 percent and 74 percent.

“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter stated. “The point that is clear to the board is that the [vaccine efficacy number]… they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”

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Authorities raise red flags about AstraZeneca’s vaccine press release

Authorities raise red flags about AstraZeneca’s vaccine press release

Enlarge (credit: Getty| NurPhoto)

A board of independent experts tasked with monitoring the data and safety of AstraZeneca’s COVID-19 vaccine trial has raised a red flag about the company’s Monday press release, which trumpeted that the vaccine was 79 percent effective at preventing symptomatic COVID-19.

In the wee hours of Tuesday, the National Institute of Allergy and Infectious Diseases released an unusual statement indicating that the trial’s Data and Safety Monitoring Board (DSMB) had been in touch with the federal agency as well as the company. The statement read:

The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

In an interview with Good Morning America Tuesday morning, NIAID director and top infectious disease expert Anthony Fauci tried to add more context to the situation. He noted that the DSMB, which has access to all of the data from the AstraZeneca trial, was left surprised by what the company said in its press release.

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Adding arthritis drug to current COVID treatment cuts deaths even more

A medical staff member adjusts a ventilator on a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on December 2, 2020 in Houston, Texas.

Enlarge / A medical staff member adjusts a ventilator on a patient in the COVID-19 intensive care unit (ICU) at the United Memorial Medical Center on December 2, 2020 in Houston, Texas. (credit: Getty | Go Nakamura)

An anti-inflammatory arthritis drug called tocilizumab modestly reduces deaths and hospital stays in patients with severe COVID-19, according to preliminary data from a randomized trial of over 4,000 patients.

Among hospitalized patients requiring oxygen in the trial, there were 596 deaths in the group of 2,022 patients randomly assigned to take tocilizumab—29 percent died—and 694 deaths in the group of 2,094 patients randomly assigned to standard care—33 percent died. That’s an absolute difference of 4 percent in deaths and a 14 percent drop in the relative rate of death.

Tocilizumab also appeared to shorten hospital stays, boosting the chances that surviving patients could leave the hospital within 28 days after randomization from 47 percent to 54 percent.

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Scary 22% vaccine efficacy in South Africa comes with heaps of caveats

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

Dismal preliminary data on AstraZeneca’s COVID-19 vaccine in South Africa—where the B.1.351/ 501Y.V2 coronavirus variant is spreading widely—lead the government there to rethink its vaccination rollout and raised further international concern about the variant.

But the small study has so many limitations and caveats, experts caution that drawing any conclusions from it is difficult.

The study, which has not been published or peer-reviewed but presented in a press conference Sunday, began in June and enrolled only around 2,000 participants, about half of which received a placebo. Early in the study—before B.1.351 emerged—the vaccine appeared over 70 percent effective at preventing mild-to-moderate cases of COVID-19. That is largely in line with the conclusion of an international Phase III trial released by AstraZeneca and vaccine co-developer Oxford University, which showed mixed results for the replication-deficient adenovirus-based vaccine but an overall efficacy of around 70 percent.

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COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%

COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%

Enlarge (credit: Getty | SOPA Images)

Johnson & Johnson’s experimental COVID-19 vaccine was 72 percent effective at preventing moderate and severe disease in the United States and 85 percent effective at preventing severe disease globally. But the one-shot vaccine struggled to fight off emerging virus variants in other countries, lowering its overall efficacy to 66 percent.

The topline results from Johnson & Johnson’s Phase III ENSEMBLE trial, announced Friday, suggest the vaccine will be yet another much-needed weapon against the pandemic virus, which has now infected over 100 million worldwide and killed nearly 2.2 million.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, global head of research and development at Janssen Pharmaceutical (owned by J&J). “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

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AstraZeneca’s COVID-19 vaccine shows success: Here’s how it stacks up to others

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

AstraZeneca announced in a press release on Monday that its COVID-19 vaccine showed positive results in an interim analysis of clinical trial data.

The announcement marks the third vaccine to show strong efficacy in late-stage trials against the pandemic coronavirus, SARS-CoV-2. Though AstraZeneca’s vaccine efficacy numbers are not as impressively high as those for the vaccines before it—mRNA vaccines from Pfizer/BioNTech and Moderna—AstraZeneca’s does offer some advantages over those vaccines.

In all, the news adds to ballooning optimism that effective vaccines could bring an end to the global crisis in the coming year.

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First COVID-19 vaccine goes to FDA today for emergency authorization

Pfizer headquarters in Manhattan, New York City, United States on November 19, 2020.

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

Today the US Food and Drug Administration will receive its first submission of a candidate vaccine to fight the pandemic coronavirus.

Pharmaceutical giant Pfizer and German biotech firm BioNTech announced early this morning that they are submitting the formal request to obtain an Emergency Use Authorization (EUA) from the FDA for the companies’ mRNA vaccine, BNT162b2.

The submission follows the celebrated news just Wednesday that the companies had wrapped up their Phase III trial and found the vaccine to be 95-percent effective at preventing symptomatic COVID-19, the disease caused by the coronavirus, SARS-CoV-2.

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More good COVID-19 vaccine news—but it won’t save us

A serious man in a suit speaks in front of a blurry World Health Organization logo.

Enlarge / Geneva: WHO Director-General Tedros Adhanom Ghebreyesus announced on March 11, 2020, that the new coronavirus outbreak can now be characterized as a pandemic. (credit: Getty | FABRICE COFFRINI)

There’s more good news on the COVID-19 vaccine front today: biotechnology company Moderna reported in a press release this morning that its mRNA vaccine appeared 94.5 percent effective at preventing COVID-19 in an interim analysis of a large, Phase III trial. The news comes exactly one week after similar results came out via press release for another mRNA vaccine developed by pharmaceutical giant Pfizer and German biotech firm BioNTech.

But while health experts are “cautiously optimistic” for this and many other vaccines in the coming months, they warn that such a timeline will not be fast enough to spare lives and health care systems from the current spike in disease.

“Right now, we are extremely concerned by the surge in cases we’re seeing in some countries,” Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said in a press conference Monday. “Particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point.”

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Pfizer dashes hope for COVID-19 vaccine data before the election

Albert Bourla, chief executive officer of Pfizer pharmaceutical company, bangs a gavel after ringing the closing bell at the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City.

Enlarge / Albert Bourla, chief executive officer of Pfizer pharmaceutical company, bangs a gavel after ringing the closing bell at the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City. (credit: Getty | Drew Angerer)

Pfizer’s chief executive has dashed any lingering hope that we’ll glimpse COVID-19 vaccine data before next week’s election.

The pharmaceutical giant has the speediest clinical-trial design among the frontrunners in the COVID-19 vaccine race. And for weeks, Pfizer CEO Albert Bourla has dangled the possibility that his company would have results by the end of October—an enticing prospect picked up by President Donald Trump, who has pushed for October vaccine news to bolster his re-election bid.

But in a call with investors Tuesday, Bourla indicated an October release was nearly impossible now. Researchers conducting the over 40,000-person trial have not yet analyzed preliminary data and, even if the data were available tomorrow, an outside panel would need at least a week to analyze any results, Bourla said.

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“Not uncommon at all”: AstraZeneca pauses COVID-19 vaccine trial

A double-masked health care worker jabs a needle into the arm of a seated woman in a mask.

Enlarge / A volunteer receives an injection of AZD1222 from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020, in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. (credit: Getty Images | Felix Dlangamandla)

With the coronavirus crisis gripping the globe, all eyes are on every bump and dip on the path to the pandemic’s end. So, of course, news that researchers triggered a common pause to the clinical trials of a leading COVID-19 vaccine candidate made swift and alarming headlines late Tuesday.

The global phase III trials for the vaccine AZD1222 (formerly ChAdOx1)—developed by the University of Oxford and pharmaceutical giant AstraZeneca—were put on a “temporary” and “voluntary” pause for a “standard review process,” AstraZeneca said in a statement Wednesday.

According the company, the pause was triggered by a “potentially unexplained illness” in one of thousands of participants involved in its trials. Per standard protocol, researchers must pause the trial to investigate whether the illness is related to exposure to the experimental vaccine or not.

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WHO gives up on hydroxychloroquine for COVID-19, stops trials

Pills of Hydroxychloroquine sit on a tray at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020.

Enlarge / Pills of Hydroxychloroquine sit on a tray at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020. (credit: Getty | George Frey)

The World Health Organization on Wednesday announced that it is abandoning use of the anti-malaria drug hydroxychloroquine in the Solidarity trial—the organization’s massive, global clinical trial of potential COVID-19 treatments.

The WHO cited early data from the trial and others showing that hydroxychloroquine does not lower the risk of death or provide any other clinical benefit in hospitalized patients.

“Investigators will not randomize further patients to hydroxychloroquine in the Solidarity trial,” the WHO said in a statement. “Patients who have already started hydroxychloroquine but who have not yet finished their course in the trial may complete their course or stop at the discretion of the supervising physician.”

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COVID-19 death rate cut by cheap steroid, according to unpublished data

 A close-up of a box of Dexamethasone tablets in a pharmacy on June 16, 2020 in Cardiff, United Kingdom.

Enlarge / A close-up of a box of Dexamethasone tablets in a pharmacy on June 16, 2020 in Cardiff, United Kingdom. (credit: Getty | Matthew Horwood)

Researchers at the University of Oxford announced Tuesday that a cheap, readily available steroid drug lowered the risk of death in COVID-19 patients who were enrolled in a randomized clinical trial and required either ventilation or oxygen during their treatment.

According to unpublished data, the steroid dexamethasone reduced the risk of death from 41 percent to about 27 percent in patients who were ventilated, and from 25 percent to 20 percent in patients on oxygen.

If the finding holds up, it would mark the first time in the five-month-old pandemic that researchers have identified a therapeutic that reduces mortality from infections with the novel coronavirus, SARS-CoV-2.

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First bit of success from a randomized trial of a COVID-19 treatment

Image of a small vial of liquid.

Enlarge / A vial of the drug Remdesivir destined for a clinical trial. (credit: ULRICH PERREY/Getty Images)

Today, Dr. Anthony Fauci announced the first potential treatment for COVID-19 had emerged from a randomized clinical trial sponsored in part by the National Institutes of Health. The drug, remdesivir, significantly shortened the recovery time for patients with COVID-19, triggering an ethical clause that allowed the placebo group to receive the real drug. Unfortunately, that cut the trial short before a significant effect on mortality was clear.

Fauci made the announcement while speaking to the press with President Donald Trump in the White House.

Wrong virus, right drug?

Remdesivir was originally developed to target a different virus: Ebola. It works by binding to the enzyme that copies the RNA genome of the Ebola virus. Since our cells don’t need to make copies of RNA, the hope has been that we can find drugs that target the viral enzyme but not any that our own cells need. Testing had already indicated it was safe for general use, suggesting that remdesivir was successful in this regard. Unfortunately, it didn’t clearly work against the Ebola virus, leaving it the very large collection of drugs that are safe but ineffective.

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Hydroxychloroquine trial for COVID-19 begins amid political debate

US President Donald Trump (L), flanked by US Vice President Mike Pence, speaks during the daily briefing on the novel coronavirus, which causes COVID-19, in the Brady Briefing Room at the White House on April 9, 2020, in Washington, DC.

Enlarge / US President Donald Trump (L), flanked by US Vice President Mike Pence, speaks during the daily briefing on the novel coronavirus, which causes COVID-19, in the Brady Briefing Room at the White House on April 9, 2020, in Washington, DC. (credit: Getty | Jim Watson)

The US National Institutes of Health on Thursday began a clinical trial to treat adult COVID-19 patients with hydroxychloroquine, a malaria drug that President Trump has repeatedly promoted during the pandemic despite a lack of evidence for its effectiveness against the new coronavirus.

The trial is one of dozens underway to test the drug, which is currently used to treat malaria and rheumatoid conditions, such as rheumatoid arthritis and lupus. At this point it only has mixed, anecdotal evidence to support its use against COVID-19.

But that hasn’t stopped President Trump from repeatedly promoting it as a promising treatment and calling for its use. In tweets last month, Trump said that a combination treatment of hydroxychloroquine and the antibiotic azithromycin “have a real chance to be one of the biggest game changers in the history of medicine.” He followed the declaration saying he hoped they will “be put in use IMMEDIATELY.”

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