COVID questions: Is vaccine approved? What to expect afterward?

Editor’s note: We will be publishing answers to questions about COVID-19 and the pandemic each week in this COVID questions column. If you have a question, please email it to covid19update@uc.wisc.edu.

Q: What can I expect after getting the vaccine?

A: With thousands of Wisconsinites vaccinated and many thousands to come in the latest group recently announced for vaccination, there are five things people should know once vaccinated.

• Get both doses: The full level of immunity is achieved 7 to 10 days after the second dose, the first dose alone does not offer that level of protection.
• If you have both doses, the vaccines currently available are approximately 95% effective. A 95% effective vaccine is extraordinary, but that still leaves a 5% chance you could contract the virus after vaccination.
• We are still learning about a vaccinated individual’s ability to carry or pass the virus while not getting sick or showing symptoms themselves. That means a vaccinated person could pass the virus to someone who hasn’t been vaccinated and make them sick.
• Don’t stop taking precautions: Everything is not back to normal. Continue to wear a mask, socially distance and avoid large gatherings, especially with current levels of community spread. We’ll need to do this until most people have been vaccinated.
• Side effect from the COVID-19 vaccines such as fever, soreness at the injection site, headache and fatigue are common but rarely severe.

Vaccines will not become broadly available to the general public for some time. For those not yet vaccinated, masking, hand hygiene and social distancing continue to be the preventive measures that work against this virus.

For more COVID-19 resources, visit coronavirus.uwhealth.org

– From UW Health newsroom

Q: We received paperwork about the vaccine that read, in part: “The Moderna Covid-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.” With that information, I’m questioning the wisdom of getting the vaccine. Can you explain?

A: The currently available COVID-19 mRNA vaccines have been reviewed and authorized for use by the US FDA, under an Emergency Use Authorization (EUA) process, and so technically they are not considered fully approved. This EUA process is used in times of urgency to enable medications to become available more quickly than usual. This had never been used before for a vaccine, but we’ve also never been in a situation quite like this current pandemic!

Given the circumstances of this pandemic, the FDA was able to develop a process and clear guidelines to allow vaccines to be reviewed in this manner. For an EUA vaccine approval, FDA essentially is requiring the vaccine developers reach the same standards in their research and development programs that is required for full approval of these vaccines by the European Union FDA. There are only some additional data that the companies are still collecting and putting together to complete their submissions for full FDA approval – which will then take some months for the final review. Until that process is completed, these vaccines are technically still considered unapproved.

But there should be no concerns about either the safety or efficacy of these vaccines. They are remarkably effective at preventing severe disease, hospitalizations and deaths. And they have been intensely scrutinized throughout the development process.  In many ways, we are fortunate that the US FDA was willing and able to adjust their processes in a manner that still maintained high standards for safety and efficacy, while allowing these vaccines to become available to the high risk public as quickly as possible. These vaccines offer our best opportunity to really control this pandemic, protect our most vulnerable, and hopefully begin gradually to return to normalcy.

– James Conway, Pediatric Infectious Diseases Fellowship Program Director and UW–Madison School of Medicine & Public Health Office of Global Health Director

See more answers to COVID questions. Also, visit our COVID-19 impact site.