What exactly is Emergency Use Authorization?
From the FDA website: “An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic…. For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.”
Which COVID-19 vaccines have received FDA approval?
The FDA has approved two vaccines at this time. The first vaccine is from Pfizer, a pharmaceutical company with a long track record in vaccines, and its partner, BioNTech, a German biotechnology company. The second is Moderna Therapeutics, a company founding in 2010 to commercialize the use of messenger RNA therapeutics (mRNA). Around 250 Wake Forest Baptist physicians and nurses are participating in the Moderna clinical trial. Both the Pfizer and Moderna vaccines use mRNA technology, require two doses about 21 to 28 days apart and are estimated to be 95% effective—similar to the vaccines for measles, mumps and rubella.
Is the COVID-19 vaccine a live vaccine?
No. The mechanism of the vaccine that stimulates antibodies, mRNA, is only a snippet of the viral genetic code, so the vaccine cannot give you the disease.
NEW: Are the two vaccines that Wake Forest Baptist is currently receiving and administering made with human diploid (aka aborted fetal) cells? If so, will there be an alternative offered to those who are opposed to such vaccines?
Because both the Pfizer and Moderna vaccines are made with messenger RNA (mRNA), no fetal tissues are involved.
What scientific data is available about the COVID-19 vaccines?
A summary of efficacy and safety data accompanies each Emergency Use Authorization. View Pfizer Fact Sheet. View Moderna Fact Sheet. Prior to being vaccinated, each person will receive this vaccine information sheet that includes pertinent safety data and explains potential adverse events. We encourage patients to view this information in advance of appointments.
The COVID-19 vaccine must be maintained in a very cold environment. Once it’s removed from the cold, how soon must it be administered to still be effective?
The Pfizer vaccine requires an ultra-low temperature in a special freezer for extended storage. Once removed, it will remain stable for five days at a regular refrigerator temperature. The Moderna vaccine can be stored in a regular freezer and will remain stable for 30 days at a regular refrigerator temperature.
Why do we need vaccines?
Vaccines are an important tool for protecting people from diseases caused by viruses or bacteria. Vaccines “train” the body’s immune system to respond and fight an invading microbe.
Vaccines have been protecting people from diseases such as polio, smallpox and measles for decades, and scientists are now developing vaccines that work against the viruses that cause HIV, Zika and most recently COVID-19.
NEW: What do we know about the COVID-19 vaccines?
There are more than 130 COVID-19 vaccines being studied in clinical trials. Vaccine trials study how patients are affected by the vaccine. Experts then compare that with patients who get a placebo (an inactive treatment that would not protect against COVID-19). This will help prove the vaccine is effective and will work. To date, two COVID-19 vaccines have been authorized by the FDA – the Pfizer and Moderna vaccines.
Is a COVID-19 vaccine necessary?
The best way to prevent infection for our patients, employees and students is to continue to follow COVID-19-safe behaviors like social distancing, handwashing and wearing a mask at all times. The COVID-19 vaccine will add an important preventive measure.
How many doses of a COVID-19 vaccine will be needed?
Per the manufacturers, the first COVID-19 vaccines being made available use two shots. The first shot starts building protection. A second shot a few weeks later is needed to get the most protection the vaccine has to offer.
How long before a COVID-19 vaccine takes effect?
Researchers are hoping people will start to have immunity to COVID-19 1 to 2 weeks after the second vaccination.
Will the vaccine need to be given every year?
We do not have enough data yet to determine. We are still studying this to better understand it before making a decision.
How long will protection last following COVID-19 vaccination?
The duration of protection is unknown. The clinical trials show that protection lasts at least two months, and robust antibody responses suggest the vaccine may be fairly long lasting. Only time will tell whether periodic boosters may be needed.
NEW: Why was Wake Forest Baptist selected to receive early doses of the vaccine?
The N.C. Department of Health and Human Services looked for sites that were able to store and manage the vaccine. We already had ultra-low temperature freezers but decided early on to purchase one with the latest technology and dedicate it to the vaccine. That capability, together with our footprint and experience as an academic medical center, were factors.
NEW: Do we know if preservatives of any kind are in the COVID-19 vaccines?
There are no preservatives. The vials are intended to be completely used once opened, rather than returned to the refrigerator, which is the usual reason for adding preservatives to injectables.
NEW: Do the number of received doses reported so far include the second dose, or only the first?
The numbers are for first doses. The CDC and N.C. Department of Health and Human Services has instructed us not to hold inventory for the second doses. We must follow stringent inventory management and submit a lot of information back to them, so they will know how many we have used and take that into account in future shipments.
NEW: How long do they expect the vaccine to be effective? Is this something we would need to get every year or every five years?
We simply do not know at this point because there has not been long enough follow-up in the clinical trials.
NEW: Will I be able to give blood if I get vaccinated?
Yes. You can give blood, just like after any other vaccine. If you have received the COVID-19 monoclonal antibody therapy because of having COVID-19, then you have to wait 90 days to give blood.
NEW: Should the AstraZeneca vaccine be available anytime soon?
A rough prediction is sometime in March or April 2021. The FDA has asked the company to do some follow-up work in certain categories of their clinical trial subjects.
NEW: Can children get the vaccine?
Younger kids are being studied now, but at this point it's not recommended that the Pfizer vaccine be administered to anyone under 16 years of age. There's no upper age limit.