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Source/Disclosures
Source:

Offit PA. Preparing hesitant Americans for a COVID-19 vaccine. Presented at: Infectious Diseases in Children Symposium; Nov. 21-22, 2020; (virtual meeting).

Disclosures: Offit reports no relevant financial disclosures.
November 21, 2020
2 min read
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Offit: Three reasons Americans may hesitate to get a COVID-19 vaccine

Source/Disclosures
Source:

Offit PA. Preparing hesitant Americans for a COVID-19 vaccine. Presented at: Infectious Diseases in Children Symposium; Nov. 21-22, 2020; (virtual meeting).

Disclosures: Offit reports no relevant financial disclosures.
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Paul A. Offit, MD, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said there are three likely reasons why Americans may be hesitant to receive a COVID-19 vaccine when one is available.

In a presentation during the virtual Infectious Diseases in Children Symposium, Offit said the language being used to describe the vaccine may come across as worrisome for the public, especially considering how fast vaccines are being developed.

Paul A. Offit

“This virus was really just isolated in January of 2020, yet we'll have a vaccine by no later than early next year,” Offit said.

According to Offit, there are more than 180 COVID-19 vaccine candidates in clinical development globally, and more than 100 companies have become involved. WHO, the Biomedical Advanced Research and Development Authority, the Gates Foundation and the U.S. government have given billions of dollars toward the effort for a vaccine, he said.

“There's never been that degree of expertise or interest in a vaccine,” Offit said.

Typically, vaccines are licensed following the completion of phase 3 trials that prove safety and efficacy, Offit said. But instead, the FDA has been administering emergency use authorizations, which Offit said could look to be “illusive, and frankly, less trustworthy.”

When a COVID-19 vaccine is approved, it will be the fastest approval for any vaccine in history.

“You're not going to do a 7-year study, you're not going to do a 4-year study with this vaccine because more than 230,000 [American] people have died just this year from this virus,” Offit said. “So, you're not going to wait that long to make sure that the vaccine is safe and effective for that length of time.”

Offit said you can find out whether a vaccine is effective and/or safe within a few months following administration, as seen with vaccines for polio or influenza.

As long as phase 3 trials are being performed, the quick pace of COVID-19 vaccine development is “at some level irrelevant,” Offit said. He noted that phase 3 trials being conducted by Pfizer, Moderna, and Johnson & Johnson, have all included tens of thousands of individuals.

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Dec. 10 to discuss Pfizer and BioNTech’s submission for an emergency use authorization for its COVID-19 vaccine. Offit sits on the committee.

A second reason for hesitancy involves a distrust of elected officials by the American people, Offit said. He referred to the FDA issuing — and then rescinding — an emergency use authorization for hydroxychloroquine, a treatment touted by President Trump.

“I think ... that people became concerned that the FDA was acting at the behest of the administration, instead of protecting Americans from products that are either unsafe or ineffective,” Offit said.

According to Offit, five U.S. states and the National Medical Association have stated they will form their own expert vaccine advisory committee because they do not trust the FDA.

A final reason for hesitancy involves the uniqueness of the virus.

“Here you have a virus, SARS-CoV-2, which has already had a number of clinical and pathological surprises,” Offit said. “I mean, it causes vasculitis, which would have never been predicted. It rages in the summer months. It can cause strokes, heart attacks, kidney disease, liver disease, so it's a bit of a surprising virus, and we are going to meet it with a series of vaccine strategies.”

Offit noted that there are a number of mechanisms in place to monitor the safety of vaccines.