US President Donald Trump on August 22 accused members of the "deep state" at the Food and Drug Administration, without providing evidence, of working to slow testing of COVID-19 vaccines until after the November presidential election.
In a Twitter post, Trump said the deep state "or whoever" at the FDA was making it very difficult for drug companies to enroll people in clinical trials to test vaccines and therapies for the novel coronavirus.
The comment came after Reuters exclusively reported on Thursday that a top FDA official said he would resign if the Trump administration approved a vaccine before it was shown to be safe and effective.
"Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!" Trump wrote, tagging FDA Commissioner Stephen Hahn in the tweet.
Trump often uses Twitter to criticize federal agencies, sometimes accusing them of being controlled by the "deep state" in an apparent reference to long-serving staff who, in Trump's eyes, are determined to undermine his agenda.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
His tweet increases the pressure on the FDA after Peter Marks, director of its Center for Biologics Evaluation and Research, last week said on a conference call with government officials, pharmaceutical executives and academics that he would resign if the agency rubber-stamped an unproven vaccine.
Scientists, public health officials and lawmakers are worried that the Trump administration will push the FDA to approve a vaccine in advance of the vote, even if data from clinical trials do not support its widespread use. Marks, whose division regulates cutting-edge biotech treatments, vaccines and gene therapies, told Reuters he has not faced any political pressure and that the FDA would be guided by science alone. Should that change, he said on Thursday, "I would feel obligated (to resign) because in doing so, I would indicate to the American public that there's something wrong."