Operation Warp Speed Head Says Vaccine Companies Should Hold Off On Authorization If They Don’t Have Millions Of Doses Ready

(PatrioticPost.com)- The companies developing COVID-19 vaccines have been told to hold off on seeking emergency use authorization for their drugs until they have an adequate supply of doses to distribute to the public.

This week, the scientific head of the U.S.’ Operation Warp Speed program, Dr. Moncef Slaoui, said he has told manufacturers of vaccines that they shouldn’t seek authorization from the Food and Drug Administration until they have enough doses on hand.

He told virtual attendees at the recent Johns Hopkins University and University of Washington Vaccine Symposium that:

“We have recommended to companies that if they achieve efficacy demonstration while no vaccine doses are available at industrial scale of several million doses to at least immunize a relevant fraction of the population, then they should refrain or consider refraining from filing an emergency use authorization, because the populations would have a major disappointment [over] expectation of the availability of the vaccine.”

An emergency use authorization represents an accelerated review by the FDA. If the FDA were to issue these, then companies would be allowed to start distributing the vaccines that have proven both effective and safe, but haven’t yet been fully approved by the FDA.

Slaoui also said during the symposium that he agreed with the FDA and its guidelines over how the agency would evaluate vaccine studies data. The FDA has recommended that all participants in the clinical trials for the vaccines be followed for two months to see if there are any serious side effects.

If the vaccine that ultimately emerges as the “victor” in the race to approval is made by either Pfizer or Moderna, then there would be no issue with a delay in emergency use authorization, Slaoui said. That’s because both of those companies have been manufacturing doses in large scale while their testing has gone on, in anticipation of needing a quick roll-out.

Pfizer and Moderna are the two companies whose vaccines are furthest along in the clinical trial phases. Late-stage testing for both of their vaccines began over the summer.

Slaoui said it’s likely both of those companies would have between 20 million to 30 million doses of their vaccine produced by November or December.

Two other companies that are far along in testing, AstraZeneca and Johnson & Johnson, may show the earliest results of effectiveness and safety. It’s possible these companies’ trials could show results in less than a months’ time.

Even if those companies’ tests show positive results, though, they would likely have to hold off on requesting an emergency use authorization. The manufacturing capability of both of these companies is much further behind where Pfizer and Moderna are at the moment.

Slaoui commented on that, saying:

“At that time, there will be very few doses of vaccine if a decision was made to approve them. So, we are working hard to accelerate manufacturing and stockpiling and will likely have a few tens of millions of doses from January onward.”

There are 25 sites across America that are dedicated to manufacturing the vaccine candidates for COVID-19, Slaoui said. Roughly half of the sites are focused on producing the vaccine itself, while the other half are focused on producing the vials and sterile equipment needed for the delivery system.