US faces calls from experts to speed up COVID-19 vaccine approval process
Jun 28, 2021
Washington [US], June 28 : As the United States is poised to miss its July 4 goal of vaccinating 70 per cent of adult Americans, calls are rising from some experts for the Food and Drug Administration (FDA) to move faster to fully approve the COVID-19 vaccines as a key step to address vaccine hesitancy.
According to The Hill, polling indicates full approval could help convince some of the remaining unvaccinated people to get the vaccine doses. Some unvaccinated people view the current emergency use authorisations for the vaccines as an indicator that they are still in experimental stage and not fully tested, despite the rigorous process that went into those authorisations.
Pharmaceutical giant Pfizer had begun submitting data for full approval on May 7, but it is still unclear when the FDA would act, thus leading to calls for it to pick up the pace. Moderna had later applied for full approval on June 1.
The rise of the highly transmissible delta variant means unvaccinated people are at increased risk, highlighting the urgency for getting shots to more people.
"I would be interested in knowing what the holdup is... It could have a big impact on people getting [vaccinated] if it is FDA approved. I think it's worth asking why it hasn't happened yet," said Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security.
"1 out of 3 American adults still unvaccinated. Pfizer initiated request on May 7. It's 6 weeks later. Data is in. Vaccines are safe and effective. It's time for full approval," said Ashish Jha, dean of the Brown University School of Public Health, on Twitter.
"If they hurry it up and don't complete their review very carefully, that will actually have the opposite effect," The Hill quoted Jesse Goodman, a former FDA chief scientist now at Georgetown University. "I think that would really undermine confidence."
Meanwhile, President Joe Biden has urged more people to get vaccinated, although he has yet to call on the FDA to move faster with the vaccine approval process.
"I predict, as soon as we go from temporary approval to permanent approval, which just takes time ... it's going to increase the number of people willing to move as well," Biden said on Thursday.
According to The Hill, a Kaiser Family Foundation poll in May found that about a third of unvaccinated people -- 32 per cent -- said they would be more likely to get the shots if a vaccine received full approval.
Experts noted that the FDA should have even more confidence for full approval as more than 170 million doses of Pfizer's vaccine have already been administered in the US -- and more than 130 million for Moderna -- with a good record of safety and efficacy.
Full approval of the COVID-19 vaccines is likely to lead to more employers requiring the vaccine for their employees, which could further boost vaccination numbers in the US and other countries.