Dec 11, 2020
Pfizer’s Vaccine Inches Closer to U.S. Approval
Everything that happened in the race to find a coronavirus vaccine this week
This week, there are 14 Covid-19 vaccines in Phase 3 trials and six approved for limited use. It is incredibly heartening to finally be able to write that a vaccine — Pfizer’s — has been approved for general use in the U.K., Canada, and Bahrain. It’s expected to be approved in the U.S. very soon.
FDA Advisory Panel votes to approve Pfizer’s Covid-19 vaccine
On Thursday, the United States Food and Drug Administration (FDA) gathered a panel of experts to discuss whether Pfizer’s Covid-19 vaccine should be granted emergency use approval (EUA). Pfizer’s vaccine, which has demonstrated 95% efficacy, has already been approved in the U.K., Canada, and Bahrain. During the grueling almost nine hour meeting, experts discussed issues including the safety of the vaccine, adverse effects and deaths (none of which were linked to the vaccine) observed in the trial, and the ethics of administering a vaccine to trial participants who had received the placebo. At the end of the meeting, members of the panel cast votes on whether to recommend the vaccine for EUA. Four voted no, one abstained, and 17 voted yes.
This does not mean that the vaccine has been approved just yet, but the recommendation from the advisory panel is considered the final hurdle a vaccine must clear before getting an EUA. The FDA is expected to greenlight the vaccine on Saturday (or Sunday, if legal or bureaucratic obstacles get in the way), according to the New York Times. “Not sure what the 18% who voted no or 5% abstaining were thinking,” tweeted Eric Topol, MD, the chair of Innovative Medicine at Scripps Research, after the vote. “But expect final FDA EUA approval for the first vaccine for the U.S. in a very short time.”
A vaccine from China receives approval from the United Arab Emirates
On Wednesday, a Covid-19 vaccine produced by Sinopharm, a state-owned Chinese pharmaceutical firm, received its first approval in the United Arab Emirates, based on preliminary data showing that the vaccine is 86% effective. It’s the first of China’s four vaccines in development to receive a rating from another government, opening the door for Chinese vaccines to be used worldwide. Many questions remain, however, because neither Sinopharm nor the U.A.E. have released data on the trials. Scientists who spoke to the New York Times expressed skepticism about the U.A.E.’s statement and criticized the lack of transparency in China’s vaccine development. Some view China’s vaccine development as an expansion of its influence, especially among southeast Asian countries like Malaysia and the Philippines, which have been promised first access to a Chinese vaccine when it becomes available, according to CNBC.
Trump’s vaccine mishandling comes to light
On Monday, the New York Times reported that the Trump administration had passed up the chance to reserve more doses of the Pfizer vaccine than originally decided on in its deal with the company over the summer. In that original deal, the White House secured 100 million doses of the vaccine for $1.95 billion. Though accounts differ as to when talks of securing additional doses occurred, the Times reported, “Several people said that during late summer or early fall, Pfizer officials repeatedly warned the Trump administration that demand could vastly outstrip supply and urged it to pre-order more doses, but were turned down.”
The U.K. cautions people with a history of anaphylaxis not to get the Pfizer vaccine
Soon after the U.K.’s vaccination campaign kicked off Tuesday, two health care workers who have experienced serious allergies in the past had reactions to the Pfizer vaccine. As it investigates the reactions, the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for the rollout of the vaccine in the U.K., issued guidance on Thursday saying that, “Any person with a history of anaphylaxis to a vaccine, medicine, or food should not receive the Pfizer BioNTech vaccine. A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine.” As I wrote on the Coronavirus Blog, allergic reactions to vaccines do happen, and though they can be serious, they are also rare. In an interview on Wednesday, infectious disease expert Anthony Fauci, MD, said people who have a history of severe allergic reactions should be prepared for a potential reaction and be ready to treat it.
