*Sources include the CDC, FDA, Pfizer, Moderna, Johnson & Johnson.
How was the vaccine tested for safety?
The FDA performs rigorous testing for safety in keeping with the process used for vaccines such as flu. Two independent scientific advisory groups also reviewed data from the COVID-19 vaccine clinical trials. The FDA has concluded that the benefit of receiving the vaccine outweighs the risk of not receiving it for most people. The Pfizer vaccine now holds full FDA approval.
Vaccine approval requires four clinical trial phases that assess its effectiveness and safety in different populations. A vaccine that has been approved as safe to use has been tested in tens of thousands of people with no significant harmful side effects noted. The current Phase 3 trials have 30,000 to 50,000 participants. The FDA advises a minimum of 3,000 participants to assess safety. Phase 4 involves ongoing monitoring and data gathering over an 8-week period following vaccination, as most adverse side effects have been shown to occur within 6 weeks following vaccination.
Who was included in the Pfizer, Moderna trials, and Johnson and Johnson trials?
The Pfizer trials included more than 40,000 people. Of those, 10% were Black and 13% Latino. In trials the Pfizer vaccine showed a protection rate of 95%. The Moderna trials included more than 25,000 people. Of those, 10% were Black and 20% were Latino. The Moderna vaccine showed a protection rate of 94%. The single-shot Johnson and Johnson trials included more than 43,700 people. Of those, 15% were Latino; 13% were Black. The Johnson and Johnson vaccine trials showed a protection rate of 66.3%.
Are there side effects?
The vaccine can cause short-term discomfort such as headache, muscle pains, fatigue, chills, fever and pain at injection site in a percentage of the people who receive them. This is the effect of your body developing immunity – it means the vaccine is working! Most trial participants reported that the discomfort went away after a day, sometimes sooner. The discomfort can be more pronounced when you receive the second shot.
How does the vaccine work and how soon will I be protected?
The vaccine does not contain any active COVID virus and do not cause COVID infection. The vaccine works within our bodies to create an immune response to the presence of COVID-19 should we be exposed to it. It will help prevent the illnesses associated with COVID-19.
Recipients of the Johnson & Johnson vaccine receive a single shot. Recipients of the Moderna and Pfizer vaccines receive two shots with vaccine material 21 to 28 days apart. You must get the second dose for the Moderna and Pfizer vaccines to work. Protection typically begins within 2 weeks after the second shot. You will still be required to wear a mask, physical distance, and use appropriate PPE while at work. Trials show the vaccine prevents disease in the vaccinated person, but definitive evidence remains to be gathered before we know you cannot transmit the disease to others.
Does the vaccine guarantee I will not contract COVID-19 and does it protect against COVID-19 variants?
No vaccine is 100% effective in all people all of the time. However, as more Americans receive the COVID-19 vaccine, data show that the Moderna and Pfizer vaccines reduce the risk of COVID-19, including severe illness and hospitalization, among vaccinated people by more than 90%. Similar data on the Johnson & Johnson vaccine, which is newer, is not yet available. Data gathered by the CDC suggest that the approved COVID-19 vaccines provide protection against new variants of the virus, particularly in minimizing serious complications and illness.
What if I have had COVID-19 already?
Trials have shown that it is safe to get the vaccine if you have already had COVID-19. If you have had a test that shows you have COVID-19 antibodies, the vaccine is still safe for your and may protect you further from future COVID-19 infections.
How long will the vaccine last?
Because the vaccine is still in the early stages, we will not know this answer for some time. It may be that the COVID vaccine is annual in the same way as the flu or will require boosters.
If I get the vaccine, and have a common side effect of fever, aches, etc., I will no longer be able to “pass” the daily screening tool. Should I still come to work?
Associates who receive the vaccine and report mild side effects listed above should return to work. Symptoms such as cough, loss of smell or taste, high fever, diarrhea, sore throat are not reported as a side effect of the vaccine and may be associated with recent infection and should be reviewed with your manager. Associates should answer the screening questions relative to exposure, travel, personal protective equipment (PPE), etc., as usual. Vaccinated associates should continue to apply the same PPE protocols while at work that they followed prior to vaccination.
