Just to circle back on the vaccine for a minute here‘s the official letter released by Pfizer CEO on the timeline for their Covid vaccine.
As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this...
www.pfizer.com
To summarize he says they need to meet 3 hurdles before they can file for emergency use authorization:
- Provide data showing the vaccine is effective in preventing Covid (at least 50%...hopefully more)
- Provide data showing the vaccine is safe. The FDA is requiring at least 2 months of safety data on at least half the trial participants following their second injection. Pfizer will continue monitoring and reporting safety data for all trial participants for two years.
- Provide manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced.
He goes on to say that depending on infections Pfizer may meet the effectiveness requirement as soon as the end of October. They have also ramped up production of the vaccine (at risk to the company) so they will have the manufacturing data already compiled by the time they are ready to apply for emergency use authorization. The final hurdle on safety cannot be met until the 3rd week of November at the earliest based on when participants were vaccinated (they must wait 2 months from the 2nd dose). If the vaccine proves effective then they will file for emergency use authorization in the US shortly after the safety hurdle is met the third week of November. The FDA would then need to review and an independent panel will make the ultimate call on EUA or not.
On the safety front, I know there was a lot of back and forth on why this vaccine can be approved in a fraction of the normal time. The 2 month safety data requirement was discussed in an interview with the Journal of the American Medical Association by Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, the FDA division that approves vaccines. He said, “Most bad reactions to vaccines come between two and three months after people get them. For instance, Guillain-Barre, perhaps it's six weeks, but for transverse myelitis, it's more like three months," Marks said. "We picked two months as something that was reasonably aggressive, yet also somewhat, kind of in the middle," said Marks "Not too aggressive, not too conservative -- in the middle."
Pfizer will be continuing to monitor their trial participants for 2 years but the key concept here is they would expect adverse reactions in 3 months or less which be well before the general public starts getting vaccinated. Just some food for thought if you are on the fence on vaccine safety.
here’s the full article which has a link halfway down to the the full Youtube video of the JAMA interview if you are really interested.
The FDA wants two months of follow-up data after volunteers get their second dose of Covid-19 vaccine as part of clinical trials testing potential coronavirus vaccines.
edition.cnn.com
