January 26, 2023 – An FDA advisory panel today unanimously supported efforts to simplify COVID-19 vaccinations with the goal of developing a one-dose approach – possibly annually – for the overall population.
The FDA wants to provide vaccine manufacturers clearer guidance on future COVID-19 vaccine development. The plan is to narrow the complex range of vaccination options and increase using these shots.
COVID stays a serious threat, causing about 4,000 deaths per week recently, in accordance with the CDC.
The 21 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously “yes” on a single FDA query:
“Does the Committee recommend harmonizing the composition of the vaccine strain for primary and booster vaccinations in the United States to a single composition, so that, for example, the composition for all vaccines currently administered would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”
In other words, wouldn't it be higher to have one vaccine that potentially combines several strains of the virus, reasonably than several vaccines – say, a primary vaccination with two doses after which a booster vaccination with different combos of virus strains?
The FDA will consider the panel's recommendations when developing recent strategies to remain ahead of the virus's evolution.
Panel members justified their support for the FDA's plan by saying they hoped a less complicated regulation would help persuade more people to get a COVID vaccine.
Pamela McInnes, DDS, noted that many individuals find it difficult to clarify that the vaccine will protect them from more severe illness in the event that they grow to be infected with COVID after vaccination.
“This is a real challenge,” said McInness, former deputy director of the National Center for Advancing Translational Sciences on the National Institutes of Health.
“The message that you would have gotten sicker and ended up in the hospital resonates with me, but I'm not sure it resonates with many people who become infected,” she said.
The plan
In the briefing document for the meeting, the FDA outlined a plan to transition from the present complex landscape of COVID-19 vaccines to a unified vaccine composition for primary and booster vaccinations.
This would require:
- Harmonization of the strain composition of all COVID-19 vaccines
- Simplifying the vaccination schedule for future vaccination campaigns to offer a two-dose series for certain young children, older adults and other people with weakened immune systems, and a single dose for everybody else.
- Establish a process for recommending vaccine strains, similar in some ways to that used for seasonal influenza vaccines, based on predominant and projected variants that may emerge by June to enable vaccine production by September
During the discussion, questions arose concerning the June goal date. Given the production schedule for some vaccines, that date may have to be pushed back, said Dr. Jerry Weir, director of the Division of Viral Products on the FDA's Center for Biologics Evaluation and Research.
“We all just have to remain flexible,” Weir said, adding that there isn't a “good pattern” yet for updating these vaccines.
Increasing vaccination rates
There was broad consensus that public support for COVID-19 vaccinations needed to be strengthened. While about 81% of the U.S. population has received a minimum of one dose of this vaccine, only 15.3% have received an updated bivalent booster dose, in accordance with the CDC.
“Anything that leads to better public communication would be extremely valuable,” said committee member Henry H. Bernstein, DO, of the Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, NY.
However, it's unclear which expectations will take priority with regard to the COVID vaccination program, he said.
“Realistically, I don't think we can achieve everything – fewer infections, fewer transmissions, less severe disease and less long Covid,” Bernstein said. “And that seems to be a big challenge for public communication.”
Panelists push for more data
Other committee members also pushed for clearer guidelines in assessing COVID vaccine targets and for more robust data.
Like his VRBPAC colleagues, Cody Meissner of Dartmouth's Geisel School of Medicine supported harmonizing the strains utilized in vaccines from different manufacturers, but added that it will not be yet clear how regularly they must be administered.
“We have to see what happens with the disease burden,” said Meissner. “Maybe we need an annual vaccination, but maybe we don't. In my opinion, it's just too early in this process to answer that question.”
Among the VRBPAC members on Thursday was one among the FDA's most vocal critics on these issues, Dr. Paul A. Offit, a vaccine expert on the Children's Hospital of Philadelphia. Offit, for instance, co-wrote an opinion piece for the WashingtonPostand argued that the There was no convincing evidence for the need for booster vaccination in healthy younger adults.
At Thursday's meeting, he supported efforts to simplify COVID vaccination plans while calling for more data on the effectiveness of those products.
“This virus will be with us for years, if not decades, and there will always be vulnerable groups who will be hospitalized and die because of the virus,” Offit said.
The CDC needs to offer more information concerning the characteristics of individuals hospitalized with COVID infections, including their age and comorbidities, in addition to details about their vaccination history, he said. In addition, academic researchers should provide a clearer picture of what immunological predictors play a job in increasing people's COVID risk.
“Then and only then can we really make the best decision about who will be vaccinated with what and when,” said Offit.
VRBPAC member Ofer Levy, MD, PhD, also urged the FDA to push for the gathering of more robust and detailed information on the immune response to COVID-19 vaccinations, reminiscent of a deeper have a look at what is occurring with antibodies.
“I hope that the FDA continues to think about how best to use this information and that they encourage – or require – sponsors to collect more information about these different arms of the human immune system in a standardized way,” Levy said. “That way we continue to learn and can keep doing better.”
In summarizing the panel’s proposals at the top of the meeting, Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said: responded to the calls made in the course of the day’s session for higher data on the effectiveness of vaccines.
“We've heard loud and clear that we need to use a data-driven approach to achieve the simplest possible vaccination regimen,” Marks said. “And it should be as simple as possible, but not oversimplified, a bit like they say about Mozart's music.”