FDA Provides Nod to Pfizer Vaccine

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FDA Gives 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 came 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 granted until 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 Advisory Committee on Vaccines and Related Biological Products on Thursday voted 17-4 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 announced 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, it is limited in 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's safety review found 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 aches, 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 aged 18 and over. Michael Kurilla, MD, PhD added in a Business Insider interview, “EEA applies only to life-threatening conditions. Severe COVID with the potential for a high risk of mortality occurs predominantly in the elderly and in people with certain chronic diseases. "

Oveta Fuller, PhD, also voted against approval. She told Business Insider that her concern was that the vaccine was too new and too little 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. He told NPR, “The (panel members) were asked, does the benefit outweigh the risk? And there is clearly a great risk to the age spectrum. This is where most of the deaths, most hospitalizations and most intensive care 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 for shipping within 24 hours and sufficient for the second dose 21 days later. Pfizer expects up to 50 million total doses to be produced worldwide by the end of the year and up to 1.3 billion doses by 2021. The U.S. 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, recently began 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 company 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 for the coming months, but the majority of people may not receive one until late 2021.

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