Hopefully ending the politicization of the covid vaccine development, Pfizer now announced they will ask for approval of their vaccine only in the second half of November, even if they still believe efficiency data will be available (and released to the public) as early as this month:
Pfizer CEO Albert Bourla said:
The second requirement [for approval] is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.
https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla
With the damed US election out of the way, this hopefully will bring some sanity back into the discussion. It also means if the Phase 3 trials work well, Pfizer, AstraZeneca (based on non-US trial data), and Moderna will probably submit their authorization requests to healthcare authorities within weeks from each other, enabling regulators to have a good look which of these frontrunners work best in which kind of patients, and maybe even not granting approval to all three if one or two of them fall short of the others.
Also, both Pfizer and Moderna emphasized that the side effects they are seeing in Phase 3 are in line with what they saw in early stage clinical testing, meaning that even as enrollment reaches tens of thousands of subjects, they did not run in any of the predicaments the Adenovirus-based candidates face.
And in even more "science is crazy amazing" news, Sanofi has
animal test data from a vaccine engineered to mimic the immune response seen in asymptomatic cases of covid, while omitting the elements of immune response associated with severe disease - thus further enhancing vaccine safety and efficiency. They will start clinical testing within 2020, as will two vaccines from Merck, one of which may be administered orally. Oh, and BioNTech is ready to send a "best of all worlds" fifth candidate into clinical testing that combines the most successful aspects of all four candidates tested earlier, including the one currently in Phase 3.
EDIT: The EU vaccine regularor European Medicines Agency (EMA) has taken on Moderna's vaccine for their "rolling review" approval process. Let's keep our fingers crossed that one or more of the early candidates check out.
EDIT2: I have not checked trial registries, so this is tinfoil hat speculation, but since Pfizer are so super bullish about their vaccine's prospects (not only in press releases, but also in costly actions, expanding their trial first to the elderly and those with underlying medical conditions like HIV, and then to children) I am pretty sure they internally have some very positive efficiency data, maybe from following up on the Phase 1/2 participants or through a separate open-label trial.