Contradicting medical science experts and ignoring that a British company was forced to suspend its work on COVID-19 clinical trials, President Donald Trump maintains that America will have a vaccine ready by Nov. 1, just ahead of the 2020 election.
“I think we can probably have it sometime in October,” Trump declared.
But that declaration seems more and more destined to have the label of an empty campaign promise from the nation’s 45th president.
“No. Absolutely not,” said Dr. James E.K. Hildreth, one of the world’s foremost immunologist, and president and CEO of Meharry Medical College in Nashville, Tennessee.
“There is no way any of the vaccines currently being studied can be proven safe and effective by Nov. 1,” exclaimed Dr. Hildreth, a recent appointee to the U.S. Food and Drug Administration’s commission that would ultimately approve vaccines.
“There’s no way that I’m going to approve a vaccine that hasn’t met all of the safety criteria,” Dr. Hildreth continued.
“The Phase 3 trial, which is the next to last phase, is the largest by far with tens of thousands of people being enrolled. We have to get 30,000 people per vaccine, which means the prospect of enrolling 30,000 people and watching them long enough to see who gets infected and who doesn’t, can’t happen in two months. As far as I’m concerned, any vaccine promise by Nov. 1 should be summarily dismissed. I would certainly not take a vaccine that came online on Nov. 1.”
Trials of a COVID-19 vaccine under development by Oxford University and the pharmaceutical company AstraZeneca was halted after one patient fell ill. Officials said that the study had reached its late stages when the unidentified patient suffered “a potentially unexplained illness.”
It’s believed that the British government has spent billions on clinical trials. The Trump administration has announced vaccine-related deals that total more than $10 billion despite no guarantees of effectiveness or that any successful vaccine would hit the market affordably.
“It’s very unlikely that we would green-light a vaccine by early November because data from late-stage clinical trials of leading vaccine candidates would not be ready by then,” said Moncef Slaoui, the head of the federal government’s vaccine accelerator.
Dr. Anthony Fauci, an immunologist and director of the National Institute of Allergy and Infectious Diseases, also threw shade at Trump’s Nov.1 promise.
“If you look at the projection of the enrollment and the kinds of things, you’ll need to get a decision about whether the vaccine is safe and effective, most of us project that’s going to be by November and December, by the end of this year,” Dr. Fauci stated. “It is conceivable that you could have it by October, though I don’t think that that’s likely.”
Dr. Hildreth also noted the “horror” stories of what has happened to African Americans’ bodies during prior research trials.
He pointed out that any vaccine must have the confidence of Black people.
“I believe if we have more African American physicians and scientists, we will have more African American participation [in clinical trials,” Dr. Hildreth stated. This month, Bloomberg Philanthropies provided Meharry Medical College with a $34 million grant to help attract more African American physicians.
“I’ve made the decision that I’m going to participate in one of the vaccine trials,” Dr. Hildreth said. “The trust issue cannot be overstated. We have to have more trusted messengers and more trusted opinion leaders to make this work.”
He warned that an approved vaccine might not be for everyone.
“If you have compromised immune system, it’s not likely that you will be allowed to participate in a vaccine study because the vaccine itself might do you harm,” Dr. Hildreth warned. “Certain cancer patients are not likely to participate because some cancers in it of themselves compromise the immune system. Some vaccines might interfere with cancer treatment, so it would not be advisable.”
