COVID-19 Vaccines: Points of View From the Arthritis Foundation and Top Experts
Two COVID-19 vaccines have been given the green light for use in the U.S. by the FDA and the CDC. The Arthritis Foundation and key experts share their insights.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have given the green light to two COVID-19 vaccines in the U.S. On Dec. 13, 2020, the Advisory Committee on Immunization Practices (ACIP), an outside group of medical experts that advises the CDC, formally issued recommendations for the use of Pfizer/BioNTech’s COVID-19 vaccine for the prevention of the virus — the final step before the vaccine was administered to the first patients on Dec. 14, 2020.
Two vaccines (developed by Moderna,Inc. and Pfizer/BioNTech) have completed phase 3 trials and reported up to 95% efficacy.
- The FDA’s vaccine advisory panel of independent scientific and infectious disease experts and statisticians recommended that the agency approve Pfizer/BioNTech’s application for emergency use authorization (EUA). The Pfizer/BioNTech vaccine received official FDA EUA approval for people age 16 and older and shipments to states and communities throughout the country has begun.
- Moderna, Inc.’s EUA application has also been approved. The vaccine is already in production.
Both vaccines are non-live and can be taken by people with autoimmune arthritis.
The CDC has developed policy statements related to national vaccine distribution. Because the supply of the COVID-19 vaccine is expected to be limited at first, on Dec. 3 the CDC recommended that it initially be allocated to health care personnel and residents of long-term care facilities. The CDC’s recommendation was based on the following goals:
- To decrease the rate of deaths and serious disease.
- Preserve the functioning of society.
- Reduce the burden COVID-19 is having on people already facing disparities.
States will develop guidelines that will likely mirror CDC guidelines on how to allocate the vaccine to the highest risk population first. As the availability of the vaccine increases, recommendations will expand to include more groups, according to the CDC. These groups include essential workers who are not in health care (food and agriculture, transportation, education, energy, water and wastewater, law enforcement), adults age 65 years and older, and those with high-risk medical conditions.
- According to the CDC, there are two groups that fall within the high-risk medical condition category: those who are at increased risk and those who might be at increased risk for severe illness from the virus that causes COVID-19. People who are immunocompromised from the use of corticosteroid or other immune-weakening medicines fall into the second (might be at increased risk) group.
The ACIP met on Dec. 1, 2020, to discuss the first-round allocation. The 15 voting members and representatives from federal science agencies and the health care industry recommended that health care workers and residents of long-term care facilities be the first to receive the vaccine.
- On vaccine safety vs. speed concerns: "This process has been done extraordinarily quickly, but not at the sake of safety or scientific integrity. These new vaccines are the fruit of years and years of incremental steps in research to improve platform technology and facilitate science that would not have been possible a decade ago. The efficacy of the [Moderna Inc. and Pfizer/BioNTech] vaccines as reported in Phase 3 trials are stunningly good in preventing clinical disease and disease severity, with no significant or severe adverse effects.” —Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, Live event on Nov. 30, 2020
- On vaccine reactions: "The clinical trials have reported reactions like fatigue, muscle ache, fever, chills, headache, more commonly occurring after a second vaccine dose. In general, the reactions are mild, maybe a little bit moderate. This data is generally what I would see in reaction to a tetanus vaccine. I look at these reactions as similar with reactions to some of the standard licensed vaccines we have on the market right now and that’s encouraging.” —Wilbur Chen, MD, vaccine researcher, professor of medicine, University of Maryland School of Medicine; chief, Adult Clinical Studies section, Center for Vaccine Development and Global Health (CVD); COVID & Arthritis: Treatments and Vaccines webinar, Oct. 21, 2020.
- On possible interactions between a COVID vaccine and a disease-modifying arthritis medication: "People who are immunocompromised and taking potent medications that suppress the immune response should not get any live vaccine. However, with the other types of COVID therapeutics we don’t believe it will be an issue. It’s not like a medication that might have toxicities and interactions with other drugs.” —Dr. Chen, COVID & Arthritis: Treatment and Vaccine webinar, Oct. 21, 2020
- On pressure from the government or the drug manufacturers to report vaccine efficacy: "The clinical trial process that determined this efficacy data was done in tandem with tens of thousands of volunteers. The Moderna [Inc.] trial had 30,000 people. The BioNTech/Pfizer trial had 44,000 people. When the data is accumulated to determine if a vaccine works, neither the government nor the companies get the data, but rather an independent data and safety monitoring board made up of vaccinologists, immunologists, virologists, statisticians and ethicists independently evaluate the data and when they feel that it truly shows efficacy. Only then do the companies get the data.” —Dr. Fauci, Facebook Live event on Nov. 30, 2020
- On vaccine uptake: "COVID-19 will continue to disrupt lives unless an ‘overwhelming majority’ of Americans take the vaccine.” —Dr. Fauci, Facebook Live event on Nov. 30, 2020
- On widespread availability: "100% of Americans that want the vaccine will have the vaccine by next June.” —Lt. Gen. Paul Ostrowski, the director of supply, production and distribution for Operation Warp Speed on MSNBC, Nov. 30, 2020
Arthritis Foundation Perspective & Recommendations
- We encourage our constituents and their families to follow the recommendations of Dr. Anthony Fauci and get the vaccine when it’s available in their state.
- We support the need for transparency and availability of detailed safety and efficacy data.
- We recommend that our constituents discuss the vaccine and any concerns they may have with their health care providers.
- We reinforce the importance of continuing to follow risk mitigation activities including mask-wearing, hand hygiene and physical distancing to slow the spread of COVID-19.
- We urge state officials to engage in vaccine distribution practices that are equitable, transparent and do not further exacerbate health care disparities.