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.

Is the COVID-19 vaccine safe?
For a vaccine to be approved, it must work in a lot of people and must be safe to use. Normally, vaccine trials take a long time. While this vaccine trial is shorter than most, experts are still making sure it will work and be safe.

Have the vaccine studies included diverse populations? Is it equally safe for everyone?
Yes. Operation Warp Speed required companies conducting clinical trials to include diverse populations, both ethnically and racially. They were not allowed to complete the trials until they hit their targets for those groups. The efficacy and safety data appears to show all groups responding well to the vaccine, including the elderly.

Have appropriate and adequate protocols been followed to ensure the safety and effectiveness of the vaccines?
Larry Givner, MD, professor, Pediatrics, offers this opinion: “We have a lot of data about it, and it appears to be very safe and very effective. I would urge people not to be frightened of the vaccine, but to feel very, very comfortable with it. I will be sure to be vaccinated at the appropriate time and the same for all my family.”

And from Christopher Ohl, MD, professor, Infectious Diseases: “I really encourage people to get vaccinated. I’m confident with the efficacy and safety data.”

NEW: Is the COVID-19 vaccine safe for pregnant women?
The FDA and the CDC’s Advisory Committee on Immunization Practices have said pregnancy is not a contraindication to vaccination. The American College of Obstetrics and Gynecology now recommends that pregnant women get vaccinated because of their higher risk of complications if they get COVID-19. If you decline until after you deliver, the vaccine would be offered to you then. You may choose to discuss this with your obstetrician.

NEW: How effective is the COVID-19 vaccine?
To receive EUA (Emergency Use Authorization) from the Food and Drug Administration, companies must show the vaccine can lower infections by at least 50 percent. This means that if there are 100 people infected by the disease per day, the vaccine should lower that to 50 per day. Both the Pfizer and Moderna vaccines are estimated to be 95% effective.

NEW: What about women who are undergoing IVF or other fertility treatments to get pregnant?
There are no known concerns with mRNA COVID-19 vaccines and fertility. If you have questions, you should discuss this with your fertility specialist. 

NEW: What about women who are lactating (breastfeeding)?
Lactating mothers will be offered the vaccine. The antibodies in breast milk could be potentially protective to the baby. Lactating mothers may choose to discuss this with their health care provider.

NEW: Are there any concerns about Guillain-Barré syndrome?
To date, no cases have been reported of this rapid-onset muscle weakness, which has occurred rarely in previous vaccines.

NEW: I've been diagnosed with seizure disorder, but they're not sure about the triggers. Will this vaccine be safe to take, or should I wait until more data is out?
From what is known about the vaccine so far, it should be safe to get.

NEW: Should patients with cancer or on chemotherapy get the vaccine?
Yes. In fact, people with cancer and on chemo have even a greater reason to get vaccinated because those are comorbidities that increase your chance of being hospitalized or dying from COVID-19.

NEW: Does this vaccine have any different effects on those who are living with auto-immune conditions, such as psoriasis or rheumatoid arthritis?
Some patients with auto-immune conditions were included in the clinical trials, and there was no difference in the number of expected events.

NEW: Can you clarify about allergies that require carrying an EpiPen?
People who carry EpiPens with them all the time are allergic to one or more environmental allergens, such as bees, or peanuts. Based on reports so far, only If you've previously had an anaphylactic reaction (drop in blood pressure, swollen lips or tongue, difficulty breathing, or vomiting) to any vaccine, should you not get the Pfizer or Moderna COVID-19 vaccine. 

NEW: Is there any information on Bell's palsy or facial paralysis being an adverse reaction to this vaccine?
There have been no more reports of these following vaccination than would be expected in the general population. Experts believe these vaccines are not associated with Bell’s palsy.

NEW: If I’m considering getting other vaccines (such as Shingrix) at the same time as the COVID-19 vaccine, will this affect the timing of getting vaccinated?
If you've had another vaccine within the past 4 weeks, then you should put off the COVID-19 vaccine until four weeks after that vaccine. If you've received the monoclonal antibody infusion as treatment for early COVID-19, then you should wait three months.

NEW: Are there any studies or tests to show that people with thyroid problems can or cannot take this vaccine?
There are no vaccines, including this one, that are withheld from people with a thyroid problem. A few vaccines are unsuitable for people with thymus disorders, which are sometimes confused with the thyroid. In general, underlying illnesses are a reason to get the vaccine, not to skip it.

NEW: How can I be sure the vaccine I received or the vaccine administered to me has been maintained at proper temperature during shipping and storage?
Pfizer ships the vaccine with a temperature-monitoring digital data logger that can graph the temperature throughout the shipping process. Our Pharmacy team strictly limits who handles the vaccine. Our Pharmacy and Employee Health monitors its refrigerators through wireless technology, and we take care to ensure that we do not compromise the product in any way from a temperature perspective before it is administered.

NEW: Can the COVID-19 vaccine affect mammogram results?
A regular screening mammogram and the COVID-19 vaccination are both vital to ensure you stay healthy. Women who receive the COVID-19 vaccine may develop swollen lymph nodes under their arm on the same side as their vaccine injection. This is a normal immune reaction to the vaccine and typically subsides in 2-4 weeks. Because these swollen lymph nodes could be seen on a mammogram and be mistaken as a potential sign of cancer, we recommend scheduling your screening mammogram at least four weeks after you receive the second COVID-19 vaccination dose.
 
If you have any changes in your breast or underarm, such as a lump or pain, contact your medical provider. The recommendations above are for women who are not significantly overdue for a screening mammogram and have no symptoms in their breast.

NEW: What are the COVID-19 vaccine side effects?

 

Several prominent vaccine scientists have compared the reaction of the COVID-19 vaccine to that of the Shingrix vaccine, which creates significant reactions in some vaccine recipients. Is this a valid comparison, and should people be concerned?
The comparison is generally valid. Both the COVID-19 vaccine and the Shingrix vaccine can cause temporary arm soreness, fever, headaches or body aches in some recipients. These short-duration effects, which confirm the immune system is making antibodies and may be treated with over-the-counter acetaminophen or ibuprofen, are preferable to the risk of experiencing shingles or COVID-19.

NEW: Are there permanent side effects or changes to DNA from getting an mRNA vaccine?
No. It cannot alter DNA. The mRNA makes only a tiny piece of the virus, the spike protein, for a little while, and then it goes away. This happens in the cytoplasm, not near the nucleus, where the DNA is located. Also, remember, this is not a live viral vaccine, so it cannot cause the COVID-19 infection.

I’m currently in the Moderna clinical trial. What if I’m offered an approved Pfizer vaccine?
Anyone who has received one dose of a given vaccine should get the same vaccine for their second dose. Clinical trial managers will sort out who got the vaccine and who got the placebo and contact participants to receive either a second dose or two doses, as appropriate.

I’m currently in the Moderna clinical trial. What if I’m offered an approved Pfizer vaccine?
Anyone who has received one dose of a given vaccine should get the same vaccine for their second dose. Clinical trial managers will sort out who got the vaccine and who got the placebo and contact participants to receive either a second dose or two doses, as appropriate.

NEW: Roughly how many subjects were involved in the trials and was there a diverse makeup of the trial?
Between the two trials, almost 80,000 people participated. Participants were diverse in age, color, ethnicity and co-morbidities. There were a fair number of elderly people, but no pregnant women or nursing home residents. Trials in children are ongoing. Of the 40,000 in the Pfizer trial, half got a placebo. Among those who got placebos, 162 got COVID-19. Among those who got the vaccine, there were eight cases.

Is there a projected timeline for when various groups who have been prioritized will receive the vaccine?
Those offered the vaccine first will include health care workers fighting COVID-19 and long-term care staff and residents, along with people age 65 years or older and frontline essential workers (e.g., first responders, corrections officers, grocery store workers, teachers). Next will come adults at high risk for exposure and at increased risk of severe illness, followed by students and then all others who want to receive the vaccine. This aligns with guidance from the N.C. Department of Health and Human Services. 

How will Wake Forest Baptist Health decide who gets the vaccine?
The vaccine supply will be limited at first, so we will follow a phased vaccination approach based on guidelines from the N.C. Department of Health and Human Services.

Those offered the vaccine first will include health care workers fighting COVID-19 and long-term care staff and residents, along with people age 65 years or older and frontline essential workers (e.g., first responders, corrections officers, grocery store workers, teachers). Next will come adults at high risk for exposure and at increased risk of severe illness, followed by students and then all others who want to receive the vaccine.

If I already had COVID-19 and recovered, should I still get vaccinated?
Yes, you should get the vaccine. There is no danger, as it will only boost your immunity. If you had COVID-19 within the last 90 days, you are probably still immune and could step aside to allow someone to be vaccinated ahead of you. But if you had COVID-19 more than 90 days ago, you should get vaccinated as soon as you have the opportunity. The duration of protection from COVID-19 vaccine is unknown and there are documented cases of people getting COVID-19 twice.

Given our dependence on the federal and state governments, if there is a delay in receiving supplies of the second dose, will it cause the first dose to be ineffective?
That would depend on the timing. A few days or even a few weeks will not make much difference. The N.C. Department of Health and Human Services has assured us that there will be enough vaccine coming and that we will get shipments weekly.

What happens if I get the first COVID-19 shot, but decide not to get the second shot?
The first shot starts building protection against COVID-19. A second shot a few weeks later is needed to get the most protection the vaccine has to offer. Therefore, without getting the second shot, there is an increased possibility of developing COVID-19.

NEW: If someone takes the first shot but misses the time period for the second shot, would the person have to do the injection series over again?
No. You don’t start over. Data show that the Pfizer and Moderna vaccines are fully effective if the second dose is given up to 35 days, and up to 42 days, respectively, after the first dose. There is no recommendation for more than two doses.

NEW: Does it matter if it’s my left arm or right arm that receives each dose of the COVID-19 vaccine?
You can choose either your left or right arm for each dose of the vaccine. There is no need to alternate arms between your first and second dose, and you do not need to get the second dose in the same arm that received the first dose. The vaccine will be just as effective no matter which arm receives the vaccine.

Once I am vaccinated, will I need to continue to wear a mask in public and socially distance with the same protocols in place today?
Yes, for a variety of reasons. The vaccines are not 100% effective; the duration of protection is unknown, and there are documented cases of people getting COVID-19 twice. It also may be possible for a vaccinated person who is exposed and has no symptoms to transmit the virus to unvaccinated people.

NEW: Should you isolate from family after this vaccine?
No, you do not need to isolate. This vaccine cannot cause COVID-19 or spread COVID-19 from person to person. 

NEW: Are there any quarantine recommendations after receiving the vaccine?
No. The vaccine is not capable of causing infection or transmitting the virus.

NEW: What is v-safe?
V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through v-safe, you can quickly tell the Centers for Disease Control and Prevention (CDC) if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from the CDC may call to check on you. V-safe will remind you to get your second COVID-19 vaccine dose if you need one. Go to vsafe.cdc.gov to sign up for v-safe with your smartphone’s browser.

NEW: What is known about the new COVID-19 strains or variants?
The new COVID-19 strain, or variant, first identified in England consists of 23 small mutations in the spike protein on the surface of the virus that attaches to our lung receptors. We’ve seen each one of these mutations pop up before during the pandemic and it hasn’t been as much of a concern. But now with all 23 of the mutations together, there’s some concern that the virus might be more transmissible, and circumstantial evidence suggests it might be.

Studies are needed to know for sure if the new variant is more transmissible and if so, how much. We also would like to know whether people are getting re-infected with the new strain. If we see people who had the usual strain of COVID-19 getting re-infected with the new variant, this would imply that antibodies developed for the normal strain will not work as well for the new strain. At this time, it does not appear that infections caused by the variant are more serious or that the antibodies produced by the vaccine would not protect us.

In the meantime, everything that we do to protect against the usual strain of COVID-19 – social distancing, wearing a mask and using proper hand hygiene – will work against the new variants, too.

NEW: Will the COVID-19 vaccines protect against the new strains?
Several experts have said they expect vaccines to protect against the new strains, and current information supports this. The World Health Organization said further investigations are required to fully understand the impact of mutations. 

It’s important that we continue to practice social distancing, mask wearing and proper hand hygiene to protect not only against the usual strain of COVID-19 but also against new strains of the virus, too.

There is considerable skepticism about vaccines in the community. Is Wake Forest Baptist planning education or outreach, specifically to nursing home areas and other populations?
Yes, in fact, we have applied for a program to work with the state to reach out to historically marginalized populations to educate them and answer their questions about the vaccine.