list of frequently asked questions about the SARS-CoV-2 vaccine that came up during recent Columbia town hall discussions. These FAQs will be updated as new vaccines and information become available.
Please be aware that you should discuss the vaccine and any questions you have about it with your healthcare provider.
Both the Pfizer and Moderna vaccines use genetic material known as messenger RNA (often abbreviated as mRNA) that cells use to make proteins. When the vaccines are injected into the body, the mRNA enters human cells and instructs the cells to make a protein that mimics the spike proteins found on the surface of the coronavirus. These vaccine-induced proteins then stimulate the immune system to produce antibodies to fight the virus. Once produced, the antibodies latch onto the virus spike protein and prevent it from entering your cells and making you sick.
The vaccines are expected to be available shortly after FDA authorization with a projected rapid distribution thereafter. In New York City, prioritization of the vaccine will follow New York State and CDC guidance which is outlined below, but could change in the future:
- Phase 1:
- Patient-facing healthcare workers
- Patients and staff in long-term care facilities
- Phase 2:
- Essential workers (e.g. first responders, grocery store workers, transit workers, firefighters, police, national guard)
- Individuals in general population deemed at particularly high risk to comorbidities and health conditions
- Phase 3:
- Individuals over 65
- Individuals under 65 with high-risk comorbidities and health conditions
- Phase 4:
- All other essential workers
- Phase 5:
- Healthy adults and children
Preliminary findings from the Pfizer and Moderna vaccine trials showed that these vaccines were more than 90% effective in preventing symptomatic COVID-19.
No serious side effects have been reported with either the Pfizer or the Moderna vaccines to date. The safety of both vaccines was determined by independent Data Safety and Monitoring Boards (DSMBs). Safety data will continue to be monitored after the vaccines begin to be used in order to determine longer term safety profiles.
It is important to note that the Pfizer and Moderna trials did not include individuals younger than 18 years old, pregnant or nursing women, or immunocompromised individuals and therefore, whether these vaccines work or are safe in these groups cannot been determined at this time.
Mild to moderate side effects have been reported for both the Moderna and Pfizer vaccines among study participants. These side effects include pain or swelling at the injection site, fatigue, chills, muscle aches, or headaches. Most of these side effects resolved promptly.
Yes, the University is committed to ensuring that all eligible individuals have access to COVID-19 vaccines, consistent with local prioritization. A University vaccination program will be applied uniformly across University units and will encompass prioritizing groups eligible for vaccination in the various phases described in question 2 above and offering them vaccination.
At this point in time, the University is strongly recommending, but not mandating vaccination.
If you are eligible as part of the priority groups included in Phase 1, you will be notified by the University once the vaccine becomes available on where and when you can get vaccinated. For groups included in in Phases 2-5, information regarding administration sites will be disseminated as New York City progresses through the vaccination phases and more vaccines become available.
Prioritization will be consistent with New York City, New York State and CDC guidance.
Vaccination provided at Columbia University, New York Presbyterian Hospital or through ColumbiaDoctors practices will be at no cost to faculty, staff and students.
Medical expenses will be covered by insurance. If you work for Columbia and are covered under a Columbia insurance program, those expenses will be paid under your. Insurance plan.
For the foreseeable future, everyone including those who were vaccinated must continue to practice protective behaviors including wearing a face covering/mask, physical distancing and other measures.
Yes, the University will monitor individuals who get vaccinated to ensure that they receive the recommended vaccine regimen (e.g. two doses for the Pfizer and Moderna vaccines), to monitor for severe side effects and to determine uptake by various priority groups.
Getting vaccinated is at present not linked to individual or institutional decisions regarding return to campus.
Preliminary data indicate that both the Pfizer and Moderna vaccines are similar in effectiveness for prevention of symptomatic COVID-19 and have similar safety. Vaccination, whether with the Modern or Pfizer vaccine, will be available based on allocation, and availability of vaccines. However, individuals will be offered the two doses from the same vaccine, as recommended.
You will be provided with information regarding the vaccine and most common side effects that have been reported.
Yes, all individuals, including those vaccinated, will need to continue to participate in the University testing program (e.g. gateway, sampling, mandatory testing). The reason for this is that the vaccines have not been shown to prevent infection, only clinical illness. It is assumed for now that individuals who have been vaccinated can still catch the SARS-CoV-2 virus and may transmit to others. Also the vaccines do not interfere with the results of the SARS-CoV-2 diagnostic testing.
No, the vaccines do not contain the virus or any part of the virus. Rather, the vaccine contains mRNA that codes for a single viral protein that is unable to replicate in the way a live virus can or cause COVID-19.
This has yet to be determined and is currently under study. The Pfizer and Moderna trials only assessed whether the vaccines prevented symptomatic COVID-19. Research is under way to determine whether these vaccines will affect risk of infection with coronavirus and whether they will have an effect on transmission to others. Until this is determined, it is critically important for everyone to get vaccinated to protect themselves and to continue practicing protective behaviors, including wearing a face covering/mask and physical distancing, to protect themselves and others from catching and transmitting the virus.
The duration of protection from COVID-19 provided by these two vaccines is not known as of yet. Researchers will continue to monitor study participants to determine the duration of protection.
Both the Pfizer and Moderna vaccines require two doses to be effective. The second dose of the Pfizer vaccine is administered three weeks after the first dose while the second dose of the Moderna vaccine is administered four weeks after the first.
The Pfizer and Moderna vaccine studies found that two doses were needed to optimize the immune response and provide protection from COVID-19. Therefore, the 2-dose regimen is strongly recommended and will be necessary for documentation of full vaccination.
No. This was not tested in the trials and there is no evidence that the vaccines are interchangeable. If you get a first dose of one vaccine, you should get a second dose of the same vaccine. Individuals administering the vaccine will be tracking this issue.
The Pfizer vaccine received Emergency Use Authorization (EUA) by the Federal Drug Administration on December 11, 2020. The meeting to review Moderna’s EUA submission is scheduled for December 17, 2020.
Per CDC recommendations, vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection, including a positive antibody test. This recommendation is based on data from phase 2/3 clinical trials suggest vaccination is safe and likely efficacious in these persons.
For persons with current SARS-CoV-2 infection, vaccination should be deferred until recovery from acute illness and can be deferred up until 90 days as current evidence suggests reinfection is uncommon in the 90 days after initial infection.
Per CDC and FDA recommendations, those who have had a severe allergic reaction to any component of the vaccine should not receive the vaccine. For those who have had a. severe allergic reaction to another. vaccine or injectable therapy (intramuscular, intravenous, or subcutaneous) the vaccine can still be administered; however, it is recommended that the. risks be discussed with a healthcare provider and that the recipient be monitored for 30 minutes post-vaccination. For those with any other allergy (food, pollen, pet, etc.), vaccination is considered safe.
Currently, there are no data on the safety or efficacy of COVID-19 vaccination in persons who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Therefore, it is recommended that vaccination be deferred for at least 90 days to avoid interference of the treatment with vaccine-induced immune responses.
Persons who have been identified as a close contact of someone with COVID-19 should defer vaccination until quarantine period has ended to avoid exposing healthcare personnel (HCP) or other persons during vaccination visit.
Currently, there are no data on the safety of COVID-19 vaccines in pregnant women, though studies to collect these data are ongoing. Per CDC recommendations, pregnant or breastfeeding person who are part of a group (e.g., healthcare personnel) who is recommended to receive a COVID-19 vaccine, may choose to be vaccinated due to their increased COVID-19 risk. A discussion with healthcare provider can help inform this decision.
According to CDC recommendations, the vaccine may be administered to persons with underlying medical conditions who have no contraindications to vaccination. This guidance is based on phase 2/3 clinical trials have demonstrated similar safety and efficacy profiles in persons with underlying medical conditions compared to those with none.
For those who are immunocompromised, safety and efficacy of vaccine has yet to be determined given the limited data for these groups. However, immunocompromised persons may still receive COVID-19 vaccine, with counseling, unless otherwise contraindicated given increased risk for COVID-19.
Under federal law, manufacturers and distributors of COVID 19 vaccines are entitled to immunity as long as there is no willful misconduct.
Under federal law, manufacturers and distributors of COVID 19 vaccines are entitled to immunity from suit as long as there is no willful misconduct. Under federal law, you cannot sue FDA for approving the vaccine.
0 Comments
please do not spam link