Final approval for emergency use of the Pfizer-BioNTech vaccine is pending after today’s successful presentation to the FDA advisory board. Exciting news. This ability to produce a vaccine and prove safety and efficacy within months is astonishing. We should all be grateful for the scientists and clinicians that made it possible. Please look at this very excellent explanation of how it works in the New York Times.
Still, more needs to be known about the vaccines. The reason this is still “Emergency Use” is that normally the company collects much more data about outcomes, both efficacy and safety. Then the FDA reviews that data before regular approval. We have some info about using it in older adolescents, but no data in children or pregnant women, two groups that will need to be studied. Data regarding efficacy and adverse events will continue to be collected and the original people in the study will continue to be followed per protocol.
The bigger question that is not clear yet- too early really to tell, is whether the vaccine decreases actual transmission of the virus. It definitely cuts down on illness, especially serious illness. But will those vaccinated decrease the risk of asymptomatic colonization that can spread SARS-CoV-2 to others? That is why mask wearing will still be needed after vaccination.
Despite the speed of rolling out this vaccine, I am pretty happy and reassured about the vaccine approval process avoiding politicization. An example is the slowed down process that is happening with AstraZeneca and its vaccine. This is still a promising and effective vaccine that is cheaper to manufacture and easier to transport- no special freezers needed. This was the vaccine that the US Government bet on for more widespread use and one reason they did not accept the extra doses from Pfizer.
However, a few mistakes were made by AstraZeneca, including a mistaken dosing issue that arose. Partly due to poor communication and partly due to error, their approval process is delayed. The New York Times article lays it out clearly. These are the sorts of things that have the FDA look more closely at the data, often asking for more, slowing the approval process down. This is how the process is supposed to work- due diligence being done. The only fortuitous part is that the dosing error of using a half dose first seems to prime the immune system to have a better response after the second dose. Still more study is needed since the numbers in that arm were low.
Success in these areas helps but is overshadowed right now by the increasing number of US deaths, yesterday more than 3000, more than Pearl Harbor, more than died on 9/11. We must continue to protect ourselves with our “Swiss cheese method” and remind our friends and families to be careful too. We are still pretty much on our own.
Wash your hands, cover your nose, keep safe six, and stay well.
And finally, my caveat is that this is my experience and my opinions, which are subject to change as more information is available, and not related to the organization I work for. Thanks for reading.