The first clues as to whether a Covid-19 vaccine is effective in preventing infections among people may have already arrived, a private agency that tracks the process and scientific research has projected, pointing to protocols and registration data from the US pharmaceutical company Pfizer. .
The dissemination of efficacy data is being closely monitored, particularly in the context of the presidential elections in the United States where President Donald Trump has repeatedly assured that a vaccine will be approved before the November 3 elections.
Pfizer is among a half-dozen experimental vaccines being tested in large-scale human trials (Phase 3), and according to scientific computing and analytics company Airfinity, it is projected to have had enough Covid-19 cases in the trial to your first interim analysis.
An interim analysis is when a trial reaches a pre-set threshold for infections, 32 for the first of four from Pfizer, for researchers to review. If no less than 76.9% (26 out of 32) of the infections are among those who received a placebo, the vaccine will have been shown to be effective in preventing disease based on the first screening criterion.
Airfinity projections suggest that Pfizer would have reached the threshold of 32 cases on September 27.
“To calculate these projected dates, we have reviewed all the clinical trial data and protocols received so far, compiling the enrollment rates of the top candidates, as well as the Covid-19 attack rate in the locations where they are running their trials. We then use a code to estimate how long it will take to reach the required number of Covid-19 cases in the test using all of this information, ”an Airfinity analyst told HT.
Pfizer CEO Albert Bourla has said in recent appearances that the company expects “conclusive” efficacy data to arrive in October, a position that experts have distrusted. On September 26, a group of 60 scientists and public health experts from leading US institutions wrote an open letter to Pfizer expressing their apprehensions and urging Bourla not to apply for regulatory clearance until all safety standards have been met.
“Pfizer’s 32-event pick is the lowest of all views so far and has been widely criticized … there appears to be concern within Pfizer itself, as the CEO has written a company-wide email after of this week’s presidential election debate. ” said the Airfinity analyst, adding that Pfizer’s choice of “four interim tests in a phase III trial is unheard of in any vaccine trial.” In the email to staff, Bourla said the company will not heed political pressure and that the references to the vaccine development process in the presidential debate were “disappointing.”
The US Food and Drug Administration (FDA), which will make the final regulatory decision, will meet on October 22 to review potential licenses and approvals of Covid-19 vaccine candidates, although it is unlikely that discuss any specific candidates, based on your meeting schedule.
According to Airfinity projections, the next candidate vaccine to reach the intermediate analysis threshold is Sinovac’s inactivated virus double-dose vaccine (October 22, Moderna’s mRNA-based double-dose candidate (October 25) and candidate from Oxford-AstraZeneca Adenovirus Vector Single Dose (24 Nov). Oxford-AstraZeneca is also experimenting with double-dose formulations that will take longer for data. Moderna is based in the United States, while Oxford and AstraZeneca are from United Kingdom.
Apart from these, Johnson & Johnson from the United States, the Gamaleya Institute from Russia, and Sinopharm and CanSino from China have the most viewed vaccine candidates. These are among the 18 vaccine candidates in phase 2 and 3 trials. Among these, five have received emergency clearance for use among the public or in some groups of people from Russia, China and the United Arab Emirates. .
