- The FDA has granted an emergency use authorization (EUA) for the Pfizer-BioNTech coronavirus vaccine for use in people 16 years or older.
- A second vaccine, from Moderna, is likely to receive an EUA in the next few days.
- Currently, the known side effect of the vaccines includes mild symptoms that normally go away within 48 hours after the injection.
- If the Moderna vaccine is approved, the U.S. healthcare system will initially have access to enough vaccine doses for 150 million people.
- In most states, healthcare workers and residents of long-term care facilities will be the first people to receive the COVID-19 vaccine.
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Now that the Food and Drug Administration (FDA) has issued emergency authorization for the first coronavirus vaccine, with doses already being distributed, you may have a lot of questions about what this means for you and your loved ones.
Here’s what we know so far.
The FDA granted an
Emergency authorization is not full FDA approval. Pfizer will continue to study the safety and efficacy of its vaccine until it has enough data to request full approval.
The FDA’s vaccine advisory committee also met on December 17 to review Moderna’s phase 3 clinical data for its vaccine. The panel voted to recommend emergency use authorization for the COVID-19 vaccine.
The FDA is likely to formally give authorization to the vaccine in the coming days.
The safety of each coronavirus vaccine is tested in pre-clinical and clinical trials. The most common side effects of coronavirus vaccines that have been approved are:
- pain at the injection site
- tiredness or fatigue
- muscle pain
- joint pain
- swelling or redness at the injection site
- feeling unwell
- swollen lymph nodes (lymphadenopathy)
These side effects last for an average of 1 to 2 days. Most people have mild or moderate symptoms, while for some people symptoms may be more severe.
A few people who have been given the Pfizer-BioNTech vaccine outside of the clinical trials have had severe allergic reactions following vaccination.
People with a known history of a severe allergic reaction to any component of a coronavirus vaccine should not receive the vaccine, recommends the FDA.
In addition, the agency says people who have a severe allergic reaction to the first dose of a two-dose vaccine should not receive the second dose.
Coronavirus vaccination rates in the United States are not yet available.
The federal government has a contract with Pfizer-BioNTech for 100 million doses of its vaccine, enough to vaccinate 50 million people because it requires two doses.
Healthcare workers across the country received the first doses of this vaccine on December 14 after the FDA issued an EUA.
The government has also pre-ordered 200 million doses of Moderna’s two-dose vaccine, enough for 100 million people.
Moderna’s vaccine will be shipped to the states as soon as the FDA issues an EUA.
Doses of the coronavirus vaccines will be limited in the beginning, so states will need to prioritize who gets vaccinated.
The Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention (CDC) voted to
States are not required to follow this recommendation, but most states are, reports the Kaiser Family Foundation.
Some states have a more detailed prioritization schedule for healthcare workers, where those with the highest COVID-19 risk are vaccinated first.
A few states also included law enforcement, people incarcerated in prisons, or people living in homeless shelters in this first round of vaccination.
The ACIP will meet again later to decide which groups should receive the vaccine in the next round. This will likely include other essential workers, older adults, and others with underlying medical conditions.
Initially, the vaccine will be available at nursing homes and other long-term care facilities, hospitals, and military facilities. CVS and Walgreens pharmacies will help with distributing the vaccine to long-term care facilities.
As more vaccine doses become available, vaccination will also be offered at pharmacies, public clinics, doctors’ offices, and mobile clinics.
The Pfizer-BioNTech vaccine has to be stored in ultra-low temperatures until ready to be used. So the distribution of this vaccine will be limited to sites with this type of specialized freezer.
The Moderna vaccine also needs to be kept frozen until use, but can be stored in a standard freezer.
To learn more about vaccine distribution plans in your area, visit your state’s health department website or check out this document from Duke University and the National Governors Association (see page 25).
The federal government has committed to making the coronavirus vaccine free for all Americans:
- The Affordable Care Act (ACA) requires most health insurers to fully cover all federally recommended preventive care, including vaccination.
- The CARES Act, passed this spring, requires insurers and Medicare to cover preventive services 15 days after a recommendation from the CDC’s vaccine advisory committee.
- Some insurers, including Aetna and certain Blue Cross Blue Shield plans, announced earlier this year that they will not bill patients for the vaccine or its administration.
- States are required to fully cover the cost of the vaccine and its administration for Medicaid enrollees.
- Health providers who vaccinate uninsured people can apply for reimbursement through a federal provider relief fund.
Even with these measures in place, some people may be asked to pay for the vaccine or a provider may charge for its administration.
This includes people who are covered by insurance plans that existed before the ACA (aka “grandfathered” plans). These plans are exempt from some of the ACA requirements.
Many vaccines are safe for
However, pregnant women were not included in either the Pfizer-BioNTech or Moderna coronavirus vaccine clinical trials.
So we cannot know for certain how well the vaccine will work in this group or if there will be side effects not seen in people who participated in the earlier phase 3 clinical trials.
This type of study needs to occur before the vaccine can be tested in a clinical trial in pregnant or breastfeeding women.
The CDC says it’s a
Dr. Emily Adhikari, assistant professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas, says pregnant women should talk to their doctor before getting the coronavirus vaccine so they can make an informed decision.
This means weighing the risks and benefits of vaccination with the risks of getting COVID-19 during pregnancy.
Adhikari, who is also medical director of perinatal infectious disease at Parkland Health and Hospital System in Dallas, recently co-authored a
This study found that women who were infected with the coronavirus during pregnancy did not have an increased risk of negative pregnancy outcomes.
“However, for the 5 percent of COVID-19 positive pregnant women who get very sick — and it’s hard to predict who that will be — the risks to both mother and baby are significant,” she said.
So women who choose to not get vaccinated should still be cautious.
“Because we don’t yet know everything about the effects of this virus on long-term health,” Adhikari said, “pregnant women should be careful to maintain safe practices like social distancing, handwashing, wearing a mask, and avoiding large crowds.”
Pfizer included some people with stable HIV infection in its phase 2/3 clinical trial, but the data from that subgroup is not yet available.
The CDC says
However, because scientists don’t yet know how well the vaccine works in people with weakened immune systems, they should still take steps to protect themselves from coronavirus infection.
The EUA for the Pfizer-BioNTech vaccine includes 16- and 17-year-olds. Moderna is requesting its EUA for people 18 years or older.
Both companies are planning studies in younger children. Until these have been completed, children under 16 will not be able to get vaccinated.