GRASONVILLE — In early December, the Food and Drug Administration approved two COVID-19 vaccines for emergency use in the United States — the first by Pfizer-BioNTech and the second by Moderna. Both have been recommended by the Advisory Committee on Immunization Practices at Centers for Disease Control.
Vaccinations in Maryland began Dec. 14, 2020. By Tuesday, Jan. 12, 152,129 Marylanders had received their first dose of COVID-19 vaccine; 9,655 had received their second dose.
As Marylanders and others throughout the U.S. continue to be vaccinated, there are many questions regarding these vaccines and vaccination. The Bay Times and Record Observer sat down with Dr. Eric Wargotz of Grasonville, senior staff pathologist, medical laboratory director and chief of pathology, emeritus, Doctors Community Medical Center, Luminis Health Care and clinical professor of pathology of the George Washington University School of Medicine, to get some answers about the vaccines.
“Both require two injections with the second injection three weeks after the first one. After the second injection, the clinical trials have demonstrated that the effectiveness of preventing COVID-19 infection or severe infection is about 95%,” Wargotz said. “Clinical trials of these are ongoing to evaluate for long-term effects and trials of additional COVID-19 vaccines are in progress.”
He noted a COVID-19 vaccine from Oxford-AstraZenaca, also requiring two doses, was recently approved in the United Kingdom and India.
Who is offered the vaccine first?
There is a limited supply of the vaccines in the United States, and since demand will exceed supply, the CDC has released guidelines on which groups should be prioritized. Each state is responsible for figuring out which citizens get the vaccines first. Maryland has adopted the CDC recommendations.
“Receiving the vaccine is not mandatory. At present, first in line, Phase 1A, to be offered vaccination are the frontline health care workers and adults living and working in long-term care facilities including nursing homes. Next, Phase 1B, are adults over 75 and frontline essential workers, including firefighters, police officers and other first responders, corrections officers, food and agricultural workers, United States Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the educational sector — teachers, support staff and day care workers, Wargotz said.
“The third group, Phase 1C, includes 65- to 74-year-olds, people over 16 to 64 with high-risk medical conditions, and other workers deemed essential not in the 1b group, though it is up to individual states to decide who falls into these second two categories. These may include people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety, and public health.”
People can check with their employers, the state health department online or their local health department to find out if they qualify as a member of any of these groups.
“The ACIP is closely monitoring clinical trials in children and adolescents (12 years and older) and will consider recommendations for use when the COVID-19 vaccines are authorized for use in persons aged less than 16 years,” Wargotz said. He did not know of any clinical trials with children under age 12.
“The goal is for everyone to be offered a COVID-19 vaccination as soon as large enough quantities of vaccine are available. The CDC expects that by the end of 2021 there will be enough vaccine to vaccinate all U.S. adults,” Wargotz said.
Are the vaccines safe?
“Traditional virus vaccines use a dead or modified version of the virus to stimulate the body to create an immune response, so it learns to recognize this virus and therefore becomes immune to it.,” Wargotz said.
“The Pfizer and Moderna COVID-19 vaccines are RNA vaccines: RNA is the information inside the virus which allows the virus to produce all the virus’ machinery. These vaccines could be produced and brought to trial so quickly because they are created in the lab and not extracted from the actual COVID-19 virus. When the RNA gets into your cells of your body, your cells make their own virus fragments, which then stimulate your body to become immune,” he explained. “This RNA injected itself is not harmful and these COVID-19 vaccines cannot cause COVID-19 infection as the vaccines do not contain the complete virus.”
The vaccines appear to be safe based on the clinical trial information and several weeks of experience with the vaccines in the U.S. and other countries, he said.
“Serious reactions requiring use of epinephrine (via epipen) have occurred and are very rare, occurring predominantly in people who have experienced serious allergic reactions requiring immediate emergency treatment in the past due to any inciting substance exposed to through eating, breathing, contact or injection,” Wargotz said. “If you have any concerns about prior allergic reactions or allergies you may have had, please contact your health care provider before getting a COVID-19 vaccination.”
Most vaccine side effects happen within days of the first weeks or, more uncommonly, months after getting a vaccine, which is why the FDA required companies to have two months of safety data before applying for emergency use authorization, he added.
Information collected in clinical trials and more recently indicate that side effects of the vaccines include fever, headache, arm soreness, redness at the injection site and sometimes a feeling of being rundown; these are also side effects noted with other viral vaccines, he said.
Government regulators, health care organizations and manufacturers will continue to collect safety data to understand any long-term adverse effects, Wargotz added. He noted the clinical trials did not include women seeking to become pregnant or pregnant women, therefore, information on any adverse effects in these groups is not available.
Do the vaccines prevent COVID-19 infection?
Neither of the two approved vaccines have been 100 percent effective in preventing infection, so some vaccinated people may still get COVID-19, he said.
“It is important to point out that the vaccine trials tested whether the vaccines prevent people from being infected with the virus. The trials focused on whether people are protected from developing disease symptoms. Therefore, it’s not clear whether vaccinated people could still develop asymptomatic infections and still be able to spread the virus to others,” Wargotz said. “Some people who got the vaccine did get sick with COVID-19, but not as sick as those who didn’t receive the vaccine.”
Some vaccines are better at suppressing severity of disease rather than reducing or eliminating transmission.
The COVID-19 vaccines have some effect on transmission spread, but it is unclear if either of the approved vaccines is better at suppressing transmission versus suppressing severity of illness, Wargotz said.
“Since the 95% immunity achieved by people in the trials required two injections of the vaccine three weeks apart, it is still possible to get COVID-19 following the first injection.”
Do I still need to still wear a mask and socially distance after being vaccinated?
“The answer is simple — yes. Full protection offered by the vaccines will take at least a month to develop following the second injection,” Wargotz said.
Also, as discussed earlier, it’s not known yet to what extent the vaccines prevent infection versus suppress illness, therefore, a vaccinated person might get the virus and pass it to others, he continued.
“It is unfortunate but vaccinated people will still need to wear masks, socially distance, wash their hands and avoid large gatherings, especially indoors. This will be needed until our health experts determine that enough people have been vaccinated and achieved immunity or achieved immunity after having been infected by COVID-19. This number is estimated to be between 60-80% of a population being immune (so-called herd immunity) before declaring an epidemic/pandemic as ‘over,’” he said.
If I had COVID-19, should I get vaccinated?
“It depends, but possibly,” Wargotz said. “You may want to get an antibody test to check to see if you have already achieved immunity.”
The CDC states that if you have been positive for COVID-19 you may be advised by your health care practitioner to get a COVID-19 vaccine because of the variable immune response and that immunity may not last more than a month to six months. Recent studies had found natural immunity for COVID-19 is robust at eight months. The CDC is continuing to evaluate information to make specific recommendations on timing.
What about immunity against the new strains (mutated forms) of the virus?
“All viruses mutate. Viral genetics change in nature over time for a variety of reasons. The discovery of a faster spreading strain (or strains) of the COVID-19 in the United Kingdom, Nigeria and South Africa has raised concern,” Wargotz said. “The identification of the UK strain in several states here in the U.S. has heightened anxiety. The CDC suggests that the approved vaccines will be effective against these strains ... the COVID-19 virus attaches to our respiratory lining cells using ‘spike’ proteins. The mutated forms of COVID-19 have somewhat different composition of their ‘spike’ proteins but it is believed there is enough remaining in common between the original and mutated form(s) that the vaccines will still be effective.”
On Tuesday, Gov. Larry Hogan announced the Maryland Department of Health had confirmed two cases of the highly contagious B-117 strain of COVID-19 in Anne Arundel County.
What should I expect before and after vaccination?
“If you are eligible now or have to wait until when the vaccine is widely available to everyone, please know that the decision is yours as to whether you want to get it. It is highly recommended, but not mandatory at this time,” Wargotz said.
“If you get a vaccine you should receive a vaccination card or printout that tells you what COVID-19 vaccine you received, the date you received it, and where you received it. You should also receive a paper or electronic version of a fact sheet that tells you more about the specific COVID-19 vaccine you received or are being offered. This fact sheet contains information to help you understand the risks and benefits of receiving that specific vaccine.”
According to protocol, all people who get a COVID-19 vaccine should be monitored on-site for at least 15 minutes for any reactions.
Your second dose of vaccine should be from the same manufacturer.
“Overall, the healthy public adult should get it,” Wargotz recommended.