COVID-19 Town Hall: Is the Vaccine Safe and Effective? With Dr. Arnold MontoJanuary 27, 2021
Now that a COVID-19 vaccine is a reality, and distribution and administration are underway, many individuals have questions related to the vaccine’s safety and effectiveness. Dr. Arnold Monto, professor of epidemiology and global public health at the University of Michigan’s School of Public Health joined the Chamber to discuss just that.
In addition to his role at the University of Michigan, Monto also serves as acting chair of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. That expertise informed insight on the authorization and approval processes for the current COVID-19 vaccines.
“We are happy to find that the FDA was saying that the only difference between emergency use—because we are in a pandemic—was the duration of follow-up for safety, which was two months instead of six months,” said Monto.
This was because most side effects are vaccines manifest in the first six weeks. The efficacy criteria were the same. As far as the vaccines still in trial processes, the single-dose Johnson and Johnson vaccine is coming up while an Astra Zeneca vaccine is undergoing additional studies.
The two approved vaccines are both mRNA vaccines and studies of their efficacy, duration, and long-term safety continue to evolve, especially amid the emergence of new variants. This ongoing monitoring will be key in determining if and/or when boosters will need to be developed.
In terms of skepticism around the vaccines’ safety, Monto pointed to clinical trials with minimal side effects. The most significant issues were isolated cases of a facial paralysis condition called Bell’s Palsy and anaphylactic, or allergic, reactions. The allergic reactions are infrequent at a rate of 11 per million. Still, as individuals are vaccinated, they are kept on-site for 15-20 minutes of observation to monitor for any reactions.
Monto’s advice for those wondering about the vaccine is to do your research and get ready to be vaccinated. Production and supply continue to pose challenges to distribution, so as soon as they are available, individuals should be prepared to make an appointment. He also noted that those who have tested positive for COVID-19 should get vaccinated because the strength of antibody responses and immunity will vary based on viral load and vary from case-to-case. The vaccine is the best bet for further protection.
“If there is supply, there are no wrong arms,” said Monto.
He hopes that priority groups will be vaccinated and distribution will be able to move to the general population in the next month or two. At that point, millions of doses will have been administered with careful follow-up, leading to continued, evolving studies.