General information on the vaccines

1. What can you tell me about the Pfizer and Moderna vaccines, and how will they prevent the spread of the COVID-19 virus?

Both vaccines are approximately 95 percent effective in preventing COVID-19. They both use a new technology involving messenger RNA (mRNA), which uses a synthetic copy of the SARS-CoV-2 virus’s genetic material. This technology tricks the body into thinking it has the virus, thereby triggering the production of antibodies.

• In comparison, other vaccines use weakened or inactivated versions of the pathogen, which causes the disease to stimulate the immune system to develop antibodies.
• mRNA vaccines are not live vaccines, nor do they use an infectious component. The vaccine thereby presents no risk of causing disease in patients who are vaccinated.
• mRNA from the vaccine never enters the nucleus of the cell; therefore, it does not interact or affect a person’s DNA.
• Although mRNA technology is relatively new, many years of study are behind it. To date, there are no mRNA licensed vaccines in the U.S.
• Both were tested in 18-year-olds, including those older than 65 years of age.
• Both require storage under very cold temperatures; it will be important for pharmacies and hospitals receiving vaccines to have the necessary for proper storage:
  • -94°F for Pfizer vaccine; and
  • -4°F for Moderna vaccine.
• Both vaccines require two doses:
  • Pfizer is given three weeks apart; and
  • Moderna is given four weeks apart.

2. What is a EUA? Does this mean that safety measures were bypassed?

EUA is an abbreviation for Emergency Use Authorization. It is a legal way for the FDA to approve new drugs or new indications for old drugs previously FDA approved for use during a declared emergency. This authority is granted to the FDA under sections of the Federal Food, Drug and Cosmetic Act.  It does not constitute approval of the drug in the full statutory meaning of approval. Still, it authorizes the FDA to allow the availability of an unapproved drug or unapproved use of a drug in a declared state of emergency. A EUA is only granted after meeting specific statutory criteria.

The vaccines were required to undergo the rigorous standards set forth by the FDA, including requirements to move through the three phases of clinical trials, and were tested in tens of thousands of people.  Also, the FDA set precise requirements before manufacturers of vaccines can submit for emergency use authorization, including:

• Two full months of safety data on 50 percent clinical trial participants after final vaccine doses
• More than 50 percent effective

3. Once vaccinated, do I still have to wear a mask?

There is more to learn about the level and extent of protection provided by these vaccines.  For that reason, it is recommended to continue with the safety precautions until we know more.

4. How long will the vaccine be effective? Will I need to take this next year?

The full length of protection is unknown at this time. However, the first patients vaccinated in March are still protected, which is nine months. The hope is three to four years, consistent with data from animal studies using other coronavirus vaccines. Even so, that is not yet proven with any of the current vaccines.

5. Are my children supposed to take the vaccine? If not, why?

Children are not advised to receive the vaccine at this time. The vaccines were not studied in children yet. The vaccines will not be recommended for children until the data can support their safety and efficacy.

Health plan coverage

1. When will I be able to get a vaccine?

Prioritization of patients for vaccine administration is dependent on several factors determined at the state level. Right now, essential health care workers and nursing home residents are being vaccinated.

Each state will decide who is included in the next phase, emphasizing those at highest risk (i.e., those older than 65, those with underlying conditions, and essential workers).

2. Where can I get the vaccination?

Check with your primary care physician (PCP) to see if they know when they may receive the vaccine and how they plan to administer it. Like flu vaccines, administering these vaccines can occur at doctors’ offices, hospitals, and pharmacies.

3. How much will the vaccine cost?

The government purchased the initial supplies of vaccines, so definitive costs are not available at this time. However, costs for the administration of the vaccine can be billed.

4. Is there a cost difference on which vaccine I get?

Expect costs to be similar between the vaccines. Additionally, out of pocket costs are unexpected for patients.

5. Will my insurance plan cover the shot? Will I be required to pay upfront? Will my out of pocket costs vary depending on the type of vaccine?

There should be no out of pocket costs expected for patients.

Clinical considerations

1. Are there any side effects from taking the vaccine?

Side effects are expected to be mild but not unexpected, with some reported as injection site soreness, low-grade fever, and headache. The vaccine intends to trigger an immune response, so some of these side effects experienced may be a good indication the vaccine is doing its job.  Two doses are required, so it will be imperative for health care providers to communicate and educate patients ahead of time with suggestions for over the counter (OTC) medications that may help with any side effects experienced.

2. Can I get the COVID virus from taking the vaccination?

No, you cannot. The vaccine is a synthetic copy of the virus. It is not an inactivated or weakened versions of the actual virus, so there is no way to contract COVID-19 from the vaccine.

3. If I have already had COVID and received a positive test or antibody test, do I need to get the vaccine?

It is unknown how long the antibodies will last. Right now, the health experts believe antibodies last for three months, but since they do not know beyond that, vaccines are recommended even in patients who have already had COVID-19.

4. How many different types of vaccines will there be, and what are the major differences? There are several different vaccines, some of which are currently in phase 3 human trials. The differences are in the technology used to make the vaccine and the number of doses required.

5. What is v-safe? How do I register and use the tool?

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.⁷

• Depending on your answers, someone from the CDC may call to check on you.⁷
• It will also remind you to get your second COVID-19 vaccine if you need it.⁷
• To register, you need your smartphone and information about the COVID-19 vaccine you received.⁷

Learn more at vsafe.cdc.gov.

Vaccines and the workplace

1. When I have been vaccinated, how do I document this to my employer, school, etc.? Each patient will receive a vaccination card after getting the COVID-19 vaccine. The card will be used:
   1. For documentation of the vaccine brand administered;
   2. As a reminder for when the patient needs to go back for the second dose; and
   3. Not as a vaccine passport.

2. Can employers require employees to take the vaccine?

The Equal Employment Opportunity Commission (EEOC), the federal agency in charge of enforcing laws prohibiting discrimination in the workplace, put forth guidance on December 16, which said: “employers can require employees to get vaccinated before entering the workplace” with exceptions.

The view is based on the fact that the law allows employers to impose requirements to ensure employees don’t pose a threat to others’ “health or safety” in the workplace. The EEOC treats the vaccines as part of the measures used to accomplish just that.

What other COVID-19 questions are on your mind? Enter your questions in the form below so PSG’s team of clinical experts can provide the answers you need in real-time.

Bonus for existing clients: If you’re interested in a more robust compendium of continuously updated COVID-19 FAQs, connect with your PSG contact.

References

1. Understanding and Explaining mRNA COVID-19 Vaccines. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/covid-19/hcp/mrna-vaccine-basics.html. Accessed December 21, 2020.
2. Ensuring the Safety of Vaccines. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html. Accessed December 21, 2020.
3. Emergency Use Authorization for Vaccines Explained. Food and Drug Administration website. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained. Accessed December 21, 2020.
4. Frequently Asked Questions about Vaccination. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html. Accessed December 21, 2020.
5. After Getting the Vaccine. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html. Accessed December 29, 2020.
6. Difference Vaccines. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html. Accessed December 29, 2020.
7. V-safe. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html. Accessed December 29, 2020.
8. When to Quarantine. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html. Accessed December 29, 2020.