“We have learned much about how to slow the spread of COVID-19 with preventive measures as well as how to treat the disease, but this has not decreased the exponential growth of COVID-19 cases, unfortunately,” says Suzanne Shea, RPh, vice president of Sharp HealthCare’s system pharmacy services. “We are now looking to the distribution of an effective and safe vaccine — and the willingness of close to 70% of Americans to receive the vaccine — for true relief from the pandemic.”
While the mumps vaccine, considered the fastest vaccine ever created, took four years to be developed before being released in 1967, the world is hoping scientists will be able to provide a safe and effective COVID-19 vaccine within 12 months or less. Recent news indicates this might actually be possible.
The U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee, made up of scientific and public health experts, will soon meet to discuss the safety and effectiveness of two COVID-19 vaccines, one created by biopharmaceutical company Moderna and another by Pfizer, Inc. in partnership with BioNTech Innovative Manufacturing GmbH of Germany. The committee will decide whether it will grant emergency use authorization for one or both vaccines in the U.S.
The United Kingdom already approved the Pfizer vaccine for use there. Three other companies — AstraZeneca, Janssen and Novavax — currently have their own COVID-19 vaccines in phase 3 clinical trials that will likely be reviewed by the FDA in the near future.
While experts such as Shea are confident about the role that approved vaccines will play in diminishing the destructive power of the virus, many people have questions about its efficacy, safety and timing. Here, we answer the top questions about COVID-19 vaccines.
Top 5 questions about COVID-19 vaccines
- How do the vaccines work?
Both the Moderna and Pfizer vaccines are mRNA vaccines. According to the Centers for Disease Control and Prevention (CDC), mRNA vaccines contain material from the novel coronavirus that causes COVID-19, which gives the body’s cells instructions for how to make copies of the protein unique to the virus. Recognizing that the protein should not be there, the body creates protective antibodies that will remember how to fight the virus in case of future infection.
The other vaccines currently in phase 3 trials are of two types:
• Protein subunit vaccines, which include harmless pieces of the novel coronavirus.
• Vector vaccines, which contain a weakened version of a live virus implanted with genetic material from the novel coronavirus that causes COVID-19.
Like the mRNA vaccine, both the protein subunit and vector vaccines prompt the body to create immune cells to fight off future infection.
- Are the vaccines effective and safe?
Moderna reports their vaccine has an efficacy rate of 94.1% in preventing COVID-19, and 100% efficacy in preventing severe COVID-19 disease. Pfizer and BioNTech say their phase 3 trial demonstrated a vaccine efficacy rate of 95%. Both vaccines are delivered in two shots over a period of three weeks, with full protection from infection by the end of week four.
The CDC reports the vaccine clinical trials have been conducted according to the rigorous standards established by the FDA to ensure the benefits of the vaccine outweigh any potential risks. What’s more, several vaccine safety monitoring systems are in place to watch for any side effects once the vaccines are distributed.
Recent documents released by the FDA in preparation for the advisory committee’s first meeting report the Pfizer vaccine performs well regardless of age, weight or race, and did not cause any serious health complications during trials. However, some participants did experience minor aches and other mild side effects, such as fever, fatigue, nausea or headache, after receiving the second dose.
- When will the vaccines be available?
According to the FDA, their decisions on the two vaccines could come within days or weeks after the advisory committee meets in early and mid-December. Government sources said they are prepared to begin administering the vaccines as soon as authorization is given. In fact, vaccine doses have already been made and are currently being distributed across the country.
- How will the vaccines be distributed?
Vaccine distribution is being coordinated by the CDC, with some doses going to health care providers from a CDC distribution site and others shipping directly from manufacturers. The CDC reports it is working with state, tribal, territorial and local jurisdictions on COVID-19 vaccination plans for each area, as well as with private entities, such as chain and independently owned pharmacies, to more widely distribute the vaccines.
While Pfizer’s vaccine needs to be kept at -80° C for transport and storage — a challenge even for large health care systems and especially difficult in rural areas — Moderna reports its COVID-19 vaccine candidate remains stable at -20° C, the temperature of most home or medical freezers, for up to six months. The differences in storage temperature requirements may affect which vaccine is distributed to certain areas throughout the U.S.
- Who will be the first to be vaccinated?
The CDC’s Advisory Committee for Immunization Practices recently met to decide who should be the first to be vaccinated. Advisors recommended that front-line health care workers and residents of nursing and long-term care facilities be included in the early vaccination group, labeled “phase 1a” of the distribution plan. Essential workers, those of advanced age, people with preexisting medical conditions, and then others will be next to be immunized.
States will likely follow the CDC’s plan, though they can make changes to better meet local needs, if necessary. According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, anyone in the U.S. who wants to get vaccinated should have access to a COVID-19 vaccine by April or May at the latest.
“We will be following the guidelines of the CDC in conjunction with the California Department of Public Health and local authorities in orchestrating the distribution of COVID-19 vaccines within our health care system,” Shea says. “And we will be incredibly pleased to be able to offer it first to our front-line health care heroes who have been working tirelessly for months to compassionately care for our patients — some with COVID-19 and others with a variety of different health concerns — as they always do.”