An important federal advisory committee at the Centers for Disease Control and Prevention has added its vote of support for the Pfizer-BioNTech COVID-19 vaccine.
In an emergency meeting Saturday, the CDC's Advisory Committee on Immunization Practices voted to recommend the first COVID-19 vaccine for use for people 16 or older in the U.S, expressing hope that the vaccine would help curb the spread of the disease that has killed more than 295,000 people in the U.S.
This follows the Food and Drug Administration's emergency use authorization issued Friday night for this COVID-19 vaccine. With Saturday's vote, the CDC's independent advisory group joins the FDA in determining the vaccine to be safe and effective for use in the U.S. population.
Once the recommendation is approved by CDC director Robert Redfield, the agency will publish it as official guidance.
This is an important step in the federal review process for new vaccines, one that normally would take place before distribution begins. However, the parent agency, the Department of Health and Human Services, decided to move ahead with distribution ahead of the CDC committee's vote. Boxes of Pfizer vaccine, packed with dry ice, are en route to hospitals around the country, Army Gen. Gustave Perna, leader of Operation Warp Speed, announced Saturday.
In comments after the vote, Dr. José Romero, ACIP chair, noted that the committee's vote represents the fruition of careful and deliberate work by its group of medical experts carried out over nine months.
"ACIP has worked to deliver a vaccine to the general public that maximizes benefits, minimizes harm, addresses issues of equity and issues of health care disparity, " he said. "The deliberations have been thorough and in depth — no question that we felt was important was left unturned. All data was presented to us as we asked for it."
Safety has been a major priority during the months of discussion, he noted. Echoing what many members of the committee said in their comments, Romero expressed personal confidence in the vaccine: "If and when my turn comes to receive this vaccine, I will receive it without hesitance."
Of the 14 voting members present for the vote, 11 voted "yes" to recommend the vaccine and three recused themselves due to conflicts of interest. A second vote to amend the adult and child/adolescent vaccination schedules was unanimous.
ACIP had previously voted on, and CDC issued guidance for, how to prioritize the first phase of distribution of the vaccine. Health care workers and residents of long-term care facilities, such as nursing homes and assisted living, are recommended to be the first to receive COVID-19 vaccines, because of their high risk of getting or dying from the disease.
While, the FDA's assessment focused on the vaccine's safety and efficacy standards, the CDC's advisers also considered the practical implications of administering vaccines. At an emergency meeting Friday, prior to authorization, the CDC committee peppered Pfizer representatives with questions about the frequency of side effects and potential adverse reactions to receiving the vaccine, which could impact how vaccines get distributed in a workplace.
"We're really concerned more about what proportion of the population may need to miss work," said Dr. Grace Lee, an ACIP member, "For health care worker vaccination, and given where we are with the pandemic, we need to retain the capacity of our health care delivery system."
Nearly 9% of people who received the Pfizer vaccine reported side effects, including pain at the injection site, fatigue, headache and muscle pain and fevers, explained the CDC's Dr. Sara Oliver at Friday's meeting. These are side effects common to other vaccines, and indicate that a person's immune system is responding to the shot.
The committee recommended the vaccine for people aged 16 and older. It's not recommended for children younger than 16, because of a lack of data for that age group. Pfizer is currently recruiting children as young as 12 for vaccine trials.
Today's vote is only the first step in the CDC's support of the roll-out of the vaccine. The agency is expected to release detailed communications to state and local health leaders in the coming days, providing guidance for how to distribute the vaccine.
That guidance should clarify questions about who might be at risk for allergic reactions, and whether pregnant or lactating women should be recommended to receive the vaccine.
This cannot come too soon, according to Claire Hannan, the executive director of the Association of Immunization Managers.
"I urge the ACIP to provide specific guidance on prioritization as soon as possible," she said in a public comment at the hearing.
In an interview with NPR, she noted this detailed guidance could help work out snags in the process. While distribution plans have been developed and tested, "there are a lot of pieces to the puzzle and we need to see how it's going to work in real time."
Public health officials in states NPR spoke to are celebrating the vaccine's authorization but caution that actually getting the vaccine to people is still a huge battle.
"It is a historical moment and it's really exciting," says Kris Ehresmann, who leads infectious disease prevention for the Minnesota Department of Health. "But it's not a moment that people have any time to savor because they're absolutely too busy getting ready to actually administer the vaccine."
She explains that there are many steps to take, including training health care workers to administer the vaccine safely. She says details about who should get the initial doses of vaccine — and who might be at risk for adverse reactions are incredibly important.
"A safe vaccine is more than just the product. It's the whole process of administration and making sure that the right people get it or don't get it," she says.
She and immunization managers across the country are waiting eagerly for the CDC to publish its detailed recommendations in a Morbidity Mortality Weekly Report. It might be up to a week before Minnesota starts inoculating anyone, she says.
Another theme of the ACIP meeting was a dire need for further funding to support state and local immunization efforts, including logistical support and public information campaigns. Multiple committee members and public commenters raised the concern.
ACIP committee member Dr. Beth Bell compared "the billions of dollars that have gone into development of vaccine" with the small sums — around $200 million so far — available for distribution.
"I think the imbalance between that kind of money and the funding that's been provided for vaccination programs and implementation is really shocking and needs to be corrected," she said "We are not going to be able to protect the American public if we don't have a way to deliver the vaccines to them."
Copyright 2020 NPR. To see more, visit https://www.npr.org. 9(MDAxODg3MTg0MDEyMTg2NTY3OTI5YTI3ZA004))
