Our Best Shot at Conquering COVID 19: Q&A with Liise-anne Pirofski, M.D.
A U.S. Food and Drug Administration vaccine advisory committee met on Thursday, December 10, and recommended approval of an emergency use authorization (EUA) request for the Pfizer-BioNTech COVID-19 Vaccine. On Friday, December 11, that authorization was granted. Dr. Liise-anne Pirofski, professor of medicine and of microbiology & immunology; chief of the division of infectious diseases; and Selma and Dr. Jacques Mitrani Chair in Biomedical Research, explains what comes next, why people should get vaccinated, and addresses concerns about the vaccine. (This Q&A was updated from an item first published in the department of medicine e-newsletter on December 10. Inside Einstein thanks Amy Sacks and Dr. Pirofski for sharing this informative content.)
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Pfizer/BioNTech received special emergency utilization authorization from the FDA on December 11 to begin providing their vaccine in the United States.
Given that the FDA has issued an EUA for the Pfizer/BioNTech COVID-19 Vaccine, what happens next?
LP: After the FDA issued an EUA for the Pfizer/BioNTech COVID-19 Vaccine, the vaccine was distributed across the country by Operation Warp Speed. On Tuesday morning, December 15, Dr. Ozuah announced that Montefiore had received its initial supply of the Pfizer/BioNTech COVID-19 Vaccine and the inaugural vaccine recipient at Montefiore was vaccinated on the same day. The vaccination program is now in progress. In accordance with CDC and ACIP guidelines, the first vaccine recipients will be heathcare providers who are at the highest risk of contracting COVID-19, including those who work in intensive care units, the emergency department, and labor and delivery units. The FDA will consider an EUA for another vaccine (Moderna) on Thursday, December 17. At this time, we do not know if this vaccine will also be available at Montefiore if an EUA is issued.
![Liise-anne Pirofski, M.D.]()
Liise-anne Pirofski, M.D.
When will Montefiore distribute the vaccine?
LP: An initial shipment of the vaccine arrived at Montefiore on Tuesday, December 15, and vaccination of healthcare providers began that afternoon.
Why should people get vaccinated
LP: Vaccination is highly likely to prevent people from becoming sick with COVID-19 and this may also protect others. The vaccine may also reduce the severity of COVID-19 even if it does not prevent infection with SARS-CoV-2. Based on publicly available data from large phase III clinical trials, the Pfizer/BioNTech and Moderna mRNA SARS-CoV-2 vaccines prevented symptomatic COVID-19 in more than 94% of vaccinated individuals. At present, it is not known if they also prevent SARS-CoV-2 transmission. Therefore, in concert with vaccination, strict adherence to universal masking, social distancing, and handwashing guidelines remain imperative.
Prevention of COVID-19 and the spread of the virus will help us recover from the devastating effects of the pandemic on our society. Vaccine acceptance is extremely important for high-risk individuals and Hispanic/LatinX and Black/African Americans, who have a substantially higher risk of hospitalization and death from COVID-19 than White/non-Hispanic persons (CDC COVID-19 data 11.30.2020 Race. Ethnicity). It is critical that individuals receive accurate and scientifically sound information on their level of risk so they can understand that vaccination is vital for their own health and the health of their families. It is also imperative that healthcare providers and entities assure access to vaccines for all individuals in whom it is recommended. We must support our community with information on vaccine safety, efficacy, and expected side effects.
The phase 1 rollout will make SARS-CoV-2 vaccines available to frontline healthcare providers and residents of nursing homes, and then to essential workers, high-risk individuals, and people over 65 years of age. It may be a year or more before all Americans can be vaccinated. This makes it necessary to continue adherence to public health measures, masks, distancing, and guidelines on congregate settings.
What is an mRNA vaccine?
LP: Vaccines contain different types of immunogens. The Pfizer/BioNTech and Moderna vaccines contain mRNA that encodes the SARS-CoV-2 spike protein. These highly immunogenic vaccines elicit very robust immune responses that can be associated with strong reactions. The Pfizer December 10th FDA briefing document details short-term mild to moderate local and systemic reactions, including injection site pain, headache, and fever. Reactions were more common after the second dose and in younger people. Some individuals needed to miss work because of them. Serious adverse reactions were less than 1.0%.
Should people who are immunocompromised be vaccinated?
LP: The Pfizer December 10th FDA briefing document states that there is insufficient evidence to make conclusions about the safety or efficacy of the vaccines in immunocompromised persons. SARS-CoV-2 RNA vaccines do not contain any viral components. The vaccine RNA is taken up by muscle cells and eliminated soon after it elicits an immune response (CDC: RNA Vaccines 11.23.2020). Since these vaccines only contain RNA, they do not pose the potential risks to immunocompromised people as live or attenuated viral vaccines. The same is likely to be true of non-replicating viral vector-based vaccines such as the Oxford-AstraZeneca vaccine which may request an EUA in the coming months. Nonetheless, RNA and non-replicating vaccines may be less immunogenic in individuals with impaired immunity than individuals with normal immune systems. The FDA briefing document also states that there is insufficient data to make conclusions about the safety or efficacy of the vaccines in pregnant and breastfeeding women, while the ACIP interim guidance states that further guidance on vaccinating pregnant women will be provided after phase III data are evaluated and the EUA request is reviewed. Pregnant women can choose to receive the Pfizer/BioNTech vaccine. Immunocompromised individuals and pregnant women are at increased risk for severe COVID-19 and should discuss vaccination with their physicians, who may seek guidance from infectious diseases experts. Hopefully, evidence-based guidance on vaccinating these groups will be available soon.
Should people who have had COVID-19 be vaccinated?
LP: Yes. People who have had COVID-19 can get re-infected and it is not known how long natural immunity lasts. ACIP interim guidance states that “previous SARS-CoV-2 infection, whether symptomatic or asymptomatic, is not considered a contraindication to vaccination and serologic testing for SARS-CoV-2 antibodies is not recommended prior to vaccination.” It is recommended that people who have had very recent infection wait until they are fully recovered before they are vaccinated. However, the optimal timing of vaccination for individuals who have had prior SARS-CoV-2 infection is not known. Hopefully, more specific evidence-based guidance on this question will be available soon.
What are some on-line resources (podcasts, webinars, and links) that can help inform us about taking the vaccine?
Posted on: Thursday, December 17, 2020