SPRINGFIELD, MA – Now there is really something to celebrate this holiday season when it comes to the COVID-19 pandemic.
The CDC – after the FDA’s decision on Friday (Dec. 11, 2020) to grant emergency authorization for the coronavirus vaccine – has formally signed off on a recommendation from the Advisory Committee on Immunization Practices for Pfizer’s vaccine to be used in people 16 and older. The CDC recommendation comes after the FDA’s decision on Friday to grant emergency authorization for the vaccine.
However, most of the general public will have to wait until April to be vaccinated as healthcare workers and those at risk are to receive the shot first.
“The COVID-19 vaccines hopefully can bring some normalcy back to our daily lives in the later part of next year, depending on how many will get vaccinated. We expect that at least in the short term, people will still need to continue to wear masks and follow social distancing. While the vaccine is shown to be very effective in preventing symptomatic infection, it is not 100% and it is still unclear how much it can prevent asymptomatic infection that allows disease transmission,” said Dr. Armando Paez, chief, Infectious Disease Division, Baystate Health.
“With the current surge, the availability of vaccine will definitely help those vulnerable populations at risk of severe infection and death from COVID-19. There are still deaths occurring attributed to COVID-19 in Massachusetts, up to 60 in one day recently, although the cumulative deaths are not as high as during the first surge,” he added.
Still public support is split on the vaccine: 60 percent of people said they were likely to get the shot, a recent Pew poll found, while more than 20 percent were strongly opposed.
It is still unknown exactly how many people need to be vaccinated against or infected with COVID-19 to achieve “herd immunity,” noted Dr. Paez.
“Experts estimate it will be in the range of 70-80%. We know that within 90 days following COVID-19 that reinfection is unlikely, however, reinfection has been reported after that. We do not know at this time for how long the vaccine will offer protection from COVID-19. Based on available data, the Pfizer vaccine is safe and very effective. Most side effects like injection site reaction, fatigue and headache resolve in 1-2 days. I believe one needs to look at the vaccine in the context of potential complications from COVID-19 illness compared to the side effects of the vaccine, then you will realize how this vaccine can prevent serious illness for you and those around you,” he said.
The following Q&A will answer many of the questions you may have about the vaccine:
Q: Who will be first to get the Pfizer vaccine in Massachusetts.
A: Among those who will receive the vaccine first as part of “Phase One” are front-line health care workers and long-term care staff and residents. They will be followed by police, firefighters, and emergency medical workers, home-based health workers, and other “non-COVID facing” health workers, according to the state’s distribution plan. As for “Phase Two” priority groups, it will include residents with two or more chronic illnesses, essential workers such as teachers, transit employees and food, sanitation, public works, and public health workers, according to the state’s priority list. After that will come adults who are 65 and over and individuals with one co-morbidity making them at higher risk for COVID-19. The vaccine will be available to the general public beginning in April as part of “Phase Three.”
Q: Where can I get the vaccine?
A: While details are still being worked out, according to Massachusetts state officials, the vaccine will be administered to patients at hospitals, community health centers, and private medical offices. Pharmacies, including CVS, Walgreens, Walmart, and OSCO, will also have access to the vaccine and will be able to vaccinate their customers. And, officials say the vaccine “will likely also be made available to local health departments for vaccinating their local residents at public clinics.” Massachusetts residents can check the Centers for Disease Control and Prevention’s (CDC) interactive website, vaccinefinder.org, to see where a COVID-19 vaccine will be available at a public health clinic. For more information, you can also contact your primary health care provider, local pharmacy, or local health department to see if, and when, they will have the vaccine available.
Q: Do the COVID-19 vaccines have side effects?
A: As with any medicine or vaccine, there will likely be some side effects with COVID vaccines. Based on data reported for the initial trials of both the Pfizer and Moderna vaccines in adults, there do not appear to be serious adverse events or safety issues related to these vaccines. Both Pfizer’s and Moderna’s vaccines do seem to cause mild or moderate side effects for up to 50% of people within the first few hours and days of both the first and second doses of each. These side effects include fever, headache, muscle aches, fatigue, and soreness and/or redness at the site of injection in the arm. The CDC and the Massachusetts Department of Public Health will be closely monitoring reports and the latest news can be found on their websites. The CDC and the Food and Drug Administration (FDA) are encouraging the public to report side effects through the Vaccine Adverse Event Reporting System.
Q: How effective is the vaccine?
A: So far, in trials that have involved tens of thousands of healthy adult volunteers, both the Pfizer and the Moderna vaccines show that they are 90-95% effective in preventing COVID-19 infection. It is still too early to know how long the effectiveness will last.
Q: Does the vaccine prevent transmission to others?
A: The vaccine will provide a 94 to 95% chance that you will not get COVID 19. However, it does not prevent transmission to others if you are already carrying the COVID-19 virus. You may be spreading the virus without knowing it if you do not have symptoms. Therefore, it will still be necessary to wear a mask and practice social distancing even after getting the vaccine.
Q: Can I get infected from the COVID-19 vaccine?
A: No, it is not possible to get COVID-19 from vaccines. The Pfizer and Moderna vaccines use RNA that encodes the spike protein of the virus – not the “live” virus itself to stimulate immunity. None of the COVID-19 vaccines can cause COVID-19.
Q: Do I need to get the COVID-19 vaccine every year like the flu vaccine?
A: It is not known yet how often a COVID-19 vaccine will have to be administered.
Q: Will the COVID-19 vaccine be free? A: Currently, there is no cost to get the vaccine.
Q: How will the vaccine be given?
A: Currently the vaccine will be an injection, the same way flu shots are given. The Pfizer and Moderna vaccines require 2 injections. The Pfizer vaccine has been authorized for emergency use and this requires a second dose 21 days from the first dose . The Moderna vaccine, which is yet to be authorized by the FDA, will require a second dose 28 days after the first dose.
Q: If I had COVID-19, do I still need to get the vaccine?
A: Research is still being conducted on how and if the vaccine should be given to those who have already had the virus. Based on available data, the vaccine does not harm those who had COVID-19 when given. We do know that you should continue following safety guidelines, including wearing a mask and social distancing. As reinfection is less likely to happen to those people within 90 days of COVID-19, the Pfizer vaccine may be given only after 90 days since the diagnosis.
Q: Do I get to choose which brand of vaccine I receive?
A: At this time, the Pfizer vaccine is the only choice until another vaccine has been approved for emergency use by the FDA. Eventually, when there are several different safe and effective vaccines available, there may be choices.
Q: Is there a minimum age to receive the vaccine?
A: Until recently, vaccine trials did not include children under the age of 16. Because of this, the Pfizer vaccine is only authorized for individuals 16 years and older. Pfizer has now included children 12 and older in current, ongoing trials. When the results for these trials become available in the future, there may be a change in vaccine recommendations.
Q: How long does it take for the vaccine to become effective?
A: It usually takes a few weeks after receiving the final course of a vaccine for the body to mount an effective immune response.
Q: Will people still have to wear a mask and social distance after getting the vaccine?
A: Yes. The current safety precautions will still be important including wearing masks and social distancing. Here are some reasons why:
• As the vaccine rolls out, there will still be high levels of infection in our communities.
• You will most likely need two doses of the vaccine in order to be highly protected. Available data show that only 52% respond to 1 dose of the Pfizer vaccine.
• Even though you have been vaccinated, it is still not 100% effective, although close to it. It is still unclear how much asymptomatic infection can be prevented by vaccination, and thus the ability to transmit the virus if you get infected.
Q: What was the process of developing the vaccine?
A: All vaccines go through a similar testing process. Once products are created in the laboratory and show evidence of safety and effectiveness in animal models, they may proceed through a progressively escalating series of human clinical trials in volunteers. Progress to each “phase” of trials depends on success in the previous one. Phase I studies are small scale human trials designed to assess safety and appropriate dosing. Phase II trials are larger human studies that assess safety in more depth and laboratory measure of effectiveness. Phase III trials are large clinical studies that seek to address safety and efficacy and are generally placebo-controlled studies, meaning that some volunteers get vaccine, and some get a non-vaccine injection.
Q: What were the length of trials? How long were people followed after the vaccination?
A: The length of phase III vaccine trials, which are the large-scale ones to determine safety and effectiveness, is based generally on reaching enough “endpoints” to show that the virus is safe and working. The main “endpoint” is the number of COVID infections that occur in each group – (vaccine and control) and how the vaccine can prevention infection.
Q: What are the outcomes of the clinical trials?
A: The Pfizer clinical trials showed that the vaccine is 95% effective in preventing infection. No serious adverse events were noted in these trials.
Q: What are the vaccines made of and how do they work?
A: None of the COVID-19 vaccines in development in the U.S. use the “live” virus that causes COVID-19. Both the Pfizer and the Moderna vaccines rely on a new technology called mRNA, the synthetic messenger RNA (mRNA). While mRNA technology is new, it has been studied for more than a decade and the COVID-19 mRNA vaccines have been carefully tested for safety. Not all vaccines work the same way. Most commonly, vaccines are made from inactivated viruses or weakened live viruses. Vaccines use antigens (substances that prompt immune responses) to train the immune system to identify threats and produce antibodies. The COVID-19 vaccines being tested by Pfizer and Moderna use the mRNA that code proteins using the host cells’ own protein-making process to make proteins, trigger an immune response, and build immunity to SARS-CoV-2 (the virus that causes COVID-19). ■