COVID-19 Vaccine Administration Program for Employers

Yes, at this point, more than 70,000 patients are enrolled in clinical trials of the two leading vaccines. Clinical trials are the primary way researchers determine if a new treatment is safe and effective. The FDA will be utilizing the data from the clinical trials data to determine if these vaccines will be initially authorized for emergency use authorization (EUA).

In clinical trials, the vaccine has been found to be well-tolerated. Most adverse events were mild or moderate in severity, and short-lived. Noted adverse effects were injection site redness, pain and swelling, fatigue, fever, chills, headache, nausea, muscle pain and joint pain. Side effects have been similar to the flu vaccine. Side effects were more pronounced following the second shot.

According to the National Institutes of Health, 37% of clinical trial volunteers to date are from racial and ethnic minority populations. Recognizing the disproportionate impact of the epidemic on underrepresented racial and ethnic communities, investigators worked with community engagement partners to enroll a diverse of pool of participants.

The FDA can issue a EUA during a public health emergency to allow the use of unapproved medical products, or unapproved uses of medical products to diagnose, treat, or prevent serious or life-threatening diseases. For the FDA to issue a EUA, the vaccines must be proven safe and effective in large (phase III) clinical trials, and certain criteria must be met, including that there are no adequate, approved and available alternatives.

Both Pfizer and Moderna have reported in phase 3 clinical trials their vaccines are over 94% effective in preventing COVID-19 infections in study participants.

COVID-19 vaccination will be an important tool to help stop the pandemic. Prevention measures such as wearing masks and social distancing help reduce your chance of being exposed to the virus or spreading it to others, but these measures are not enough. Public health officials and medical experts believe vaccination is an important step in helping to prevent or lessen the effects of this illness.

The FDA will evaluate all vaccines using the same thorough review process regardless of the manufacturer. Both vaccines currently being reviewed by the FDA have been shown to be at least 94% effective.

Messenger RNA vaccines—also called mRNA vaccines—are likely to be some of the first COVID-19 vaccines authorized for use in the United States. mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

While there are currently no licensed mRNA vaccines in the United States, researchers have been studying and working with them for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means the process can be standardized and scaled up, making vaccine development faster than traditional methods of making vaccines. This new technology has enabled a short development timeline for several of the COVID-19 vaccines. As with most new vaccines, the long-term effects are currently unknown.

In early clinical trials for various COVID-19 vaccines, only non-pregnant adults participated. However, clinical trials continue to expand those recruited to participate. Based on data from the expanded clinical trials, groups recommended to receive the vaccines could change in the future. We expect additional recommendations regarding the vaccine in pregnant and breastfeeding women to come from the FDA and CDC around the time the vaccines are authorized. At this point in time, we do not have enough information to answer this question.

In early clinical trials for various COVID-19 vaccines, only non-pregnant adults participated. However, clinical trials continue to expand those recruited to participate. The groups recommended to receive the vaccines could change in the future. Once a vaccine is available, there will be guidance on who should receive it from the vaccine manufacturer. At this point in time we do not have enough information to answer this question.

The long-term side effects of the vaccines are unknown, but research is ongoing. At this point, no long-term safety issues have been detected. As more people get vaccinated and as time passes, additional data will be available. The CDC and medical professionals will be continuously reporting and reviewing vaccine safety and will act on new safety concerns as necessary.

There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this. Until we have a vaccine available and the Advisory Committee on Immunization Practices makes recommendations on how to best use COVID-19 vaccines, we cannot yet make a recommendation of whether those who had COVID-19 should get a COVID-19 vaccine.