Now that a COVID-19 vaccine has finally arrived, there is much confusion and disinformation being circulated about both the coronavirus and vaccines against it. The purpose of this column is to give the readers of this newspaper specific and accurate information about the vaccines that are and soon will be available so that, when the opportunity presents itself, you can make an informed decision on whether or not to get the vaccine. Here are the current and future vaccines developed so far:
1.Pfizer – messenger RNA (mRNA), Two doses required 21 to 28 days apart, requires a temperature of -94 degrees Fahrenheit (F) during transport, can be refrigerated at 36-46 F for five days. Emergency use authorization (EUA) approved by the FDA on 12/11/20. U.S. purchased 100 million (M) doses with option for another 500M.
2.Moderna – mRNA, Two doses required 21 to 28 days apart, transport at -4 F, can store at 36-46 F for 14 days. U.S. purchased 100 M doses with option for 400M more. The Moderna vaccine got EUA from the FDA on Friday (12/18/20).
- AstraZeneca/Oxford – modified adenovirus, Two doses required 21 to 28 days apart, requires refrigeration only, expected to get EUA in January 2021. U.S. purchased 300M doses
- Johnson & Johnson – modified adenovirus, One dose only, requires refrigeration only, expected to receive EUA in January or February 2021. US purchased 100M doses with option for 200M more.
Both the Pfizer and Moderna vaccines have been shown to be 95% effective at preventing a COVID infection beginning seven days after the second dose. Efficacy was consistent across age, gender, race and ethnicity demographics. Observed efficacy in adults 65 and older was 94%. No Grade 4 safety concerns were observed (requiring ER or hospitalization) and the only Grade 3 (prevents daily activity) adverse events greater than 2% in frequency were fatigue (3.8%) and headache (2.0%). Fever greater than 102 F was reported in 1.2%. The most common side effects, in descending order were fatigue, headache, muscle pain, chills, joint pain, fever, and diarrhea. Side effects rarely lasted more than two days and were more common after the second dose. Older adults tended to report fewer and milder side effects. The only contraindication to vaccination is a known history of allergy to it. Those with a history of severe allergic reactions should only take the vaccine at a site that has emergency services available (i.e., a hospital). Anyone pregnant or breastfeeding should consult their OB/GYN provider. None of the vaccines contain any preservatives or mercury.
As to safety, the FDA requires that a study should have a minimum of 3000 trial participants to assess safety. The trials for the Pfizer and Moderna vaccines had 30,000 to 50,000 participants each. There are two advisory committees that ensure that the vaccines are safe and effective. They are the Vaccine and Related Biological Products Advisory Committee (VRBPAC) that advises the FDA and the Advisory Committee on Immunization Practices (ACIP) that advises the CDC. Both advisory boards are independent and made up of experts from academic institutions who are vetted for conflicts of interest. Messenger RNA vaccines are a new type of vaccine. They work by giving our immune systems proteins containing instructions on how to make antibodies to the virus. The protein cannot build a virus. M RNA vaccines are also used to fight cancers. Two of the proposed vaccines contain modified adenovirus particles and are similar to current vaccines such as the flu vaccine. None of these vaccines contain live or killed viral particles, meaning that none of these vaccines can give you COVID-19.
An EUA is used to get a vaccine available quickly during a crisis to save lives. The process is sped up, but no steps are skipped in the safety evaluation process, and the FDA, with the VRBPAC and ACIP, will still review all the data and information. At present, it is unknown how long immunity from vaccination will last. It is conceivable that COVID vaccination may become an annual recommendation, akin to the flu vaccine. As noted above, the first shot may give you some mild side effects. This does not mean that the vaccine has given you COVID-19. Rather, it means that the vaccine has activated your immune system. In other words, the vaccine is doing its job and it is vital that you follow through with the second dose. In some cases, an individual being vaccinated may already have COVID-19 and not realize it (no symptoms). If they later develop symptoms or test positive for the virus, it does not mean that they got COVID-19 from the vaccine. After you are vaccinated, it is important to still wear a mask and maintain social distance as others around you may not have been vaccinated yet (remember, no vaccine is 100% effective so there’s still a chance, albeit a small one, that you could be infected despite being vaccinated). You will receive a card at the time of your first vaccination. Bring it with you for your second shot and keep it on your person.
Initially, the vaccine will be offered to healthcare professionals, first responders including police, fire, and EMS personnel, and nursing home patients. As more vaccine becomes available, it will be given first to those at increased risk from the virus like older people and those with chronic diseases, especially if they impact the immune system. Eventually, it will be offered to the general public. At present, vaccination, while strongly advised, is voluntary. For more information you may ask the vaccine provider, contact your local or state health department, or visit these websites:
By Peter Galvin, MD
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