FDA Offers Nod to Pfizer Vaccine

The Pfizer / BioNTech vaccine against Covid-19 was finally approved for emergency approval by the U.S. Food and Drug Administration late Friday night for people aged 16 and over. The decision comes after a security review, months of testing, and heavy pressure from the Trump administration, which reportedly told FDA chief Stephen Hahn, MD, that his resignation would be expected if the vaccine’s emergency approval was not given by Friday said Dr. Hahn, his conversation with President Trump’s chief of staff, Mark Meadows, was reported inaccurately.

The vaccine

The FDA’s decision comes a day after the Vaccines and Related Biological Products Advisory Panel on Thursday voted 17 to 4 in favor of recommending approval after a grueling 8.5-hour session (fully available on YouTube). This vaccine, jointly developed by Pfizer in the USA and BioNTech in Germany, has been approved in both the UK and Canada. Britain has started vaccination.

Pfizer’s data, first disclosed as interim results in a press release in early November and then made available to the FDA for emergency approval two weeks later, shows the vaccine is more than 90% effective at preventing Covid-19 – data however, limited to younger people, a concern for some panel reviewers.

Patients are given two doses three weeks apart to achieve the 90% effectiveness rate. Storage of the Pfizer vaccine requires extremely cold temperatures (the company recommends an environment of -70 ° C) and special equipment for shipping and storage.

The concerns

The FDA safety review concluded that “no specific safety concerns were identified that would preclude the issuance of an EEA”, although some patients reported side effects such as injection site reactions, headache, muscle pain, chills, joint pain and fever. Two people vaccinated in the UK had severe allergic reactions and four of the 40,000 participants in the study developed Bell’s palsy, a condition that includes facial paralysis.

The no-votes mainly concerned the approved age range. Archana Chatterjee, MD, PhD, dean of Chicago Medical School, told CNN that her “no” was out of concerns about limited data on younger patients. A third member, Dr. David Kim, director of the vaccines division for the Infectious Diseases and HIV / AIDS Policy Department at the Department of Health and Human Services, agreed. He told CNBC that he would have voted yes if the EEA had only been for patients 18 years and older. Michael Kurilla, MD, PhD added in a Business Insider interview, “EUA only applies to life-threatening conditions. Severe COVID with the potential for a high risk of mortality occur predominantly in older populations and those with certain chronic diseases. “

Oveta Fuller, PhD, also voted against approval. She told Business Insider that her concerns centered on the vaccine being too new and lacking in information – she would like at least two more months of Phase 3 study dates. Cody Meissner, MD of Tufts University School of Medicine, was the only abstinent. As he explained to NPR: “[Panel members] the question was asked, do the benefits outweigh the risks? And there is clearly a great risk to the age spectrum. This is where most of the deaths, most of the hospitalizations and most of the ICU admissions occur. If you look at kids, they’ll get infected. No question. But they don’t get sick. “

the next steps

The Independent reported that Pfizer had 2.9 million doses ready to ship within 24 hours and sufficient for the second dose 21 days later. Pfizer estimates that up to 50 million total doses will be produced worldwide by the end of the year and up to 1.3 billion doses by 2021. The US has already received 100 million doses of the Pfizer vaccine, all of which are slated to ship by the end of March.

Moderna, whose vaccine is slated for EEA assessment during a panel discussion on December 17, has recently started studies on adolescents in preparation for vaccinations for the 2021-2022 school year. The United States has ordered 100 million doses of this vaccine pending approval, with the same delivery date in March and another 100 million expected by June.

A third vaccine candidate from Oxford University and pharmaceutical giant AstraZeneca is facing increased regulatory scrutiny and concerns from the scientific community over dosing issues, issues with participants receiving their second dose on time, and the trial’s failure to test a specific dose Highly effective in people over 55 years of age. A fourth vaccine from GSK and the French company Sanofi was recently postponed to the end of 2021.

Take them home

After the EUA has been issued, the vaccines can be distributed. Vaccine candidates from Moderna and other companies, if approved, should help sustain vaccine supplies in the coming months, but the majority of people may not receive one until late 2021.

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