The FDA late Friday night finally gave its formal approval of Pfizer’s coronavirus vaccine candidate, paving the way for COVID-19 vaccinations to now begin in the US.
The Friday night approval of Pfizer’s vaccine by the FDA sets the stage for an historic public vaccination to now begin in the US.
Other coronavirus vaccines from makers like Moderna are still forthcoming in the US, as well, once they receive approval of their own.
The US Food and Drug Administration late Friday night finally gave a green light to Pfizer’s request for an emergency use authorization for its coronavirus vaccine candidate.
Here’s a letter from the FDA to Pfizer’s authorizing Pfizer’s vaccine for emergency use. The approval, which had actually been expected to happen sometime on Saturday, paves the way for shipments of the long-awaited vaccine to begin to get underway around the US. And, more importantly, for the first Americans to finally be given an officially approved vaccine for the pathogen that, through Friday, has killed just shy of 300,000 Americans based on Johns Hopkins University data.
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Rivals FedEx and UPS have already mapped out a comprehensive vaccine distribution plan that will now be enacted, a plan that entails both companies having essentially divided up the US into two. In Senate testimony on Thursday, UPS president of global healthcare Wes Wheeler explained that this bifurcation of the country means that “we know exactly what states we have and (FedEx knows) what states they have.” Both companies are also giving overnight, VIP treatment for the vaccine deliveries through their networks.
For an idea of what that looks like in practice, at FedEx, the vaccine shipments will be routed through the company’s Express division, which has cold chain capabilities required for the storage of Pfizer’s vaccine. FedEx Express is also more suited to delivering time-sensitive shipments, like a vaccine, whereas the peak season flow of e-commerce and other holiday-related packages are flowing through FedEx’s Ground division, so FedEx will be able to easily accommodate the overnight shipments of COVID-19 vaccines around the country without disrupting its normal business.
Even though the FDA’s full and final approval of Pfizer’s emergency use authorization application was expected on Saturday, it must also be noted that the Trump administration reportedly intervened in the process at the 11th hour. According to a senior administration official, who spoke anonymously to the NYT, the FDA sped up the announcement of its approval, so that it would happen Friday night, after President Trump’s chief of staff Mark Meadows told FDA head Dr. Stephen Hahn earlier on Friday the following: If Pfizer’s vaccine was not approved on Friday, he should consider looking for another job.
An FDA advisory panel had already voted to approve Pfizer’s vaccine, and, as expected, that recommendation carried the day when the full FDA took up the matter.
President Trump tweeted out the following video message Friday night offering his own comments about the vaccine approval:
Meanwhile, among some of the key facts about the vaccine to know:
The documents that the FDA released online ahead of the meeting revealed all the information that Pfizer and BioNTech couldn’t fit in the press releases announcing the vaccine’s Phase 3 efficacy. We learned, for example, that the vaccine starts building up immunity around 14 days after the first dose — and that the first of the two doses of Pfizer’s vaccine only has an efficacy of 52%. The shots will be given a few weeks apart, and you need to get both in order to get the best possible protection.
The way the drug works, it will train the immune system to raise an army of neutralizing antibodies to prevent the virus from infecting cells. As a result, severe COVID-19 can be avoided, and lives can be saved in the process. If enough people get vaccinated, herd immunity will be reached, at which point the community transmission of COVID-19 will drop significantly.
From the FDA’s announcement about the Pfizer approval Friday night: “The FDA has determined that Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria for issuance of an (emergency use authorization). The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19.
“The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”