On Tuesday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to consider how the first doses of COVID-19 vaccines will be allocated and how and to whom they will be administered.
As of Monday morning, two pharmaceutical companies have requested the U.S. Food and Drug Administration emergency use authorization (EUA) so they can begin to distribute the vaccine.
On Nov. 20, Pfizer became the first pharmaceutical company to request the FDA’s permission to begin using its COVID-19 vaccine, and then on Monday morning, Moderna announced it would seek FDA approval for use of its vaccine.
Both Pfizer’s BNT-162b2 vaccine and Moderna’s mRNA-1273 are messenger RNA vaccines, or, in the case of COVID-19, vaccines that give instructions to cells to make a harmless version of the “spike protein” that is found on the surface of the virus that causes COVID-19.
Cells are then instructed to create antibodies to fight the spike protein when it has been detected in a person’s body, after they have been infected by the novel coronavirus.
Both of the vaccines have shown an efficacy rate of more than 90%, with Moderna claiming its vaccine is 100% effective at preventing severe cases of the virus.
The FDA is scheduled to meet on Dec. 10 to consider Pfizer’s request for emergency use authorization. Moderna says it has received word that its FDA hearing will be on Dec. 17.
Who will get the first doses?
According to Health and Human Services Sec. Alex Azar, once the FDA approves a vaccine, ACIP will meet within 24 hours to finalize plans for distribution. The vaccine, Azar said, will be shipped out to states beginning 24 hours after the FDA grants approval.
ACIP met last week to do preliminary work on identifying groups that are likely to be the first to get the vaccine.
According to the website Contagion, ACIP has prioritized the distribution of the vaccine into two phases.
Phase 1A would include vaccines for health care personnel who work in:
- Hospitals
- Long-term care facilities
- Outpatient home health care
- Pharmacies
- Emergency medicine
- Public health
Phase 1B would include:
- Essential workers: people who work in food and agriculture, food service, transportation, education, energy, manufacturing, IT, communication, water and wastewater, or who are police or firefighters.
- People with high-risk medical conditions: those with diabetes, COP (cryptogenic organizing pneumonia), heart conditions, chronic kidney cancer, sickle cell disease or who have received a solid organ transplant. Also included in this group are those who are obese, who are severely obese and who smoke.
- Adults 65 years and older.
Azar stressed that once the vaccines are approved for emergency use, states will decide who gets the first COVID-19 shots.
Azar told Politico that governors will have “final say” about how the vaccine is distributed.
“We are not dependent on any delay for ACIP in terms of helping to advise states on prioritization” of vaccines, Azar said of the CDC panel.
“We hope our recommendations will carry weight with [states] but at the end of the day, they will make that decision.”
How many doses would be needed to vaccinate that many people?
According to the Bureau of Labor Statistics, there are an estimated18.8 million healthcare workers, including doctors, nurses, home health care workers, nursing home and assisted living facility employees and support staff.
An estimated 40-60 million people are considered essential workers in the U.S., and 80-100 million people are believed to have high-risk health conditions.
The Pfizer and Moderna vaccines require two doses. According to Azar, there are around 40 million doses available now, meaning 20 million people could be vaccinated in the first round.
Currently, there are 37 vaccines in either phase 1, 2 or 3 testing trials. Ten of the 37 are in phase 3 trials, and two, the Pfizer and Moderna vaccines, have applied for an emergency use authorization.
If the clinical trials go as expected and the results are submitted to the FDA for approval, millions of doses of the vaccine could be ready in the coming three to four months.
Cox Media Group
