A lab technician sorts blood samples for a COVID-19 vaccine study at the Research Centers of America in Hollywood, Florida.
A COVID-19 Vaccine By Election Day In The US? Experts fear that in the face of an uphill battle for re-election, President Donald Trump may press for one to be approved before the November 3rd vote, but also before tests prove it is effective and safe for the public to use.
– Where are vaccine tests located?
Two producers, Pfizer and Moderna, began final phase 3 trials on July 27th. Paul Mango, a senior official with the U.S. Department of Health, said last week they had needed 15,000 volunteers out of 30,000 so far.
Pfizer's vaccine requires two doses in 21 days and Moderna's two doses in 28 days. They're using the same new technology, focusing on messenger RNA, which shows promise but has never been found in a vaccine.
In preliminary tests on dozens of test persons, both vaccines triggered immune responses. However, that alone does not prove that they would protect against infection.
Another vaccine being developed by Oxford University and AstraZeneca has already entered phase 3 testing in several countries and has just started trials in the US.
– What would lead to approval?
In studies, half of the participants receive the vaccine and the other half a placebo. If the vaccine works, over time more patients receiving the placebo will naturally become infected with the coronavirus and become ill. However, there are fewer cases among those who receive the real vaccine.
To get faster results, the vaccine developers are working in areas with high COVID-19 infection rates. CDC Director Robert Redfield said the placebo group needs to register 150-175 coronavirus infections to know the vaccine is working, compared to only a few in the vaccine group.
– Who approves a vaccine?
In the United States, the Food and Drug Administration is reviewing the test data and can issue an emergency permit to allow early release to the public.
Paul Offit, member of the FDA vaccine advisory board, said independent experts on data and safety monitoring boards are monitoring the studies and reviewing the results. You need to determine if and when the phase 3 data is clear enough to show that the vaccines are safe and effective. Manufacturers can then request an emergency permit.
The final decision goes to FDA Commissioner Stephen Hahn. Some experts question Hahn's ability to withstand political pressure when the results of the vaccine trials are inconclusive.
– The timeline
The RCA center in Holloywood, Florida that conducts coronavirus vaccine research
Most experts think it makes sense to complete phase 3 testing by the end of the year.
Anthony Fauci, the country's leading infectious disease expert, said Thursday that the first results could be in "November or December".
But it is clear that the White House is aiming for something sooner.
We "will produce a vaccine before the end of the year or maybe even sooner," Trump told supporters at the Republican National Convention last week.
Then the Centers for Disease Control and Prevention urged states to put vaccine distribution systems in place "urgently" in order to be operational "by November 1, 2020".
And the government pre-purchased hundreds of millions of doses of vaccine to get them to the public as soon as possible.
However, Fauci said it would be difficult to get ready in October before the elections.
"That's unlikely, not impossible," Fauci told CNN.
The concern is that for approval for emergency use, the bar for deciding on a safe and effective vaccine is lower than for normal approvals.
"How can you justify an inferior or inferior rating for something injected into tens of millions, maybe hundreds of millions of Americans?" said Peter Hotez, an American health and vaccines expert at Baylor College of Medicine in Texas.
However, Fauci insisted that the role of independent experts in the process ensures that the FDA does not make a policy decision.
"We can have some confidence in what the FDA is saying," said Fauci.
White House spokesman Kayleigh McEnany denied any pressure to get the vaccine out before the election.
"Nobody is pressuring the FDA to do anything," she said Thursday. "The priority here is to save lives."
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© 2020 AFP
A vaccine before the US elections? Depends on science or politics (2020, September 3rd)
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