- A key FDA advisory panel voted to use the same formulation for all COVID-19 vaccinations.
- This may help streamline and clarify COVID-19 vaccination recommendations.
- Before this change goes into effect, the FDA must sign off on the committee’s recommendation, which the agency is likely to do.
The Food and Drug Administration’s independent vaccine advisory committee voted unanimously on Thursday in favor of having all COVID-19 vaccines in the United States use the same formulation as the two-strain updated boosters.
This change would make vaccination less confusing to both patients and healthcare workers, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said.
The committee voted 21-to-0 to direct vaccine makers Moderna, Pfizer-BioNTech and Novavax to update the primary series of their vaccines — the initial doses that people receive — to match the updated bivalent booster doses which target both the original strain of SARS-CoV-2 and a newer Omicron strain.
The original strain is no longer circulating, but Omicron variants related to the one targeted by the updated bivalent boosters continue to spread.
Before this change goes into effect, the FDA must sign off on the committee’s recommendation, which the agency is likely to do.
Simplified vaccination process
Dr. James Cutrell, an associate professor of medicine in the Division of Infectious Diseases and Geographic Medicine at UT Southwestern Medical Center in Dallas, said having one type of COVID-19 vaccine will make it easier not just for the public, but also for healthcare workers.
“It will simplify things for people who are administering the vaccine,” he said, “and will probably lead to less wastage of the vaccine, because you don’t have to stock two versions of it.”
In addition, if the FDA decides to update the vaccine in the future, it will only have one vaccine to consider updating, said Cutrell, who is not a member of the FDA’s advisory committee.
Some discussion at Thursday’s meeting suggested that the current complexity of having two types of COVID-19 vaccines and vaccination schedules for different age groups may also be contributing to the low vaccination rates in the United States.
“Part of the discussion around why we haven’t had better booster uptake is because the process is complicated,” said Dr. John Sellick, Jr., an infectious diseases professor in the Jacobs School of Medicine & Biomedical Sciences at the University at Buffalo.
Currently, about 70% of Americans have received the full primary series, according to the Centers for Disease Control and Prevention (CDC).
However, only 16.5% of those eligible have gotten an updated bivalent booster. And among higher-risk older adults, only 4 in 10 have received an updated bivalent booster.
Primary series vaccination rates among younger children are even lower, according to data presented at Thursday’s meeting — 3% in children 6 months to 2 years, and 5% in 2- to 4-year-olds.
Hospitalizations have also increased among children under the age of 2 over the past year, compared to other pediatric age groups, the committee heard.
“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the CDC’s Division of Birth Defects and Infant Disorders.
“We have to do much, much better,” she said, adding that simplifying the process by having a single COVID-19 vaccine would help get more children vaccinated.
Cutrell, however, still thinks the main benefit of this change will be simplifying the process for healthcare workers.
“I don’t think the switch to one type of vaccine is going to have a meaningful impact on motivating people who aren’t interested in getting vaccinated,” he said.
Data supports bivalent vaccines
While FDA documents released before the meeting emphasized the convenience of a single COVID-19 vaccine, the panel also heard data showing that the bivalent vaccines are effective.
In November 2022, people ages 5 years and older who received an updated bivalent booster were 2.4 times less likely to die of COVID-19 compared to those who were vaccinated but did not get the bivalent booster.
Moderna also presented new data from a randomized clinical trial in the UK of the bivalent BA.1 booster. People who received the bivalent booster had a lower risk of COVID-19 than those who were boosted with the original vaccine.
The bivalent vaccine used in the UK targets the BA.1 Omicron variant, while US vaccines target the BA.4 and BA.5 Omicron variants. These variants are all related to the currently circulating Omicron variants.
Sellick, who is not a member of the FDA’s advisory committee, said the benefits of COVID-19 boosters are backed up by science.
“When you look at it from the point of view of antibody levels … boosting at some regular interval is good,” he said.
In addition, “we now have clinical data showing that people who have the primary series and are boosted continue to have good protection against bad outcomes — going to the hospital or going to the morgue, the ultimate bad outcome,” he said.
FDA proposes annual COVID-19 shots
Members of the panel were also supportive of FDA scientists’ proposal to shift to an annual COVID-19 vaccine dose for most Americans.
According to the plan, the vaccine would be matched each year to the currently circulating strains of SARS-CoV-2, the coronavirus that causes COVID-19.
Most adults, adolescents and older young children who were previously vaccinated would receive a single dose each year, according to the FDA plans.
High-risk older adults, those with compromised immunity and young children not previously vaccinated would receive additional doses.
Cutrell said the FDA and CDC will need to decide which people would benefit the most from yearly COVID-19 vaccines.
Based on data presented at the meeting, he said this will likely include older people, those who are immunocompromised and possibly very young children.
In the UK, fall COVID-19 boosters are only recommended for people 50 years or older, those at high risk from COVID-19, pregnant people, and frontline health and social care workers.
Potential updates for COVID-19 in coming years
The FDA’s proposed plan would have the VRBPAC meet each year in May or June to discuss whether the formulation of the COVID-19 vaccines should be updated to more closely match the variants that are circulating at the time.
This timing would allow mRNA vaccine manufacturers to redesign the vaccines and release new doses for a fall roll-out.
However, this timing might not work for the protein-based Novavax vaccine. The company indicated at the meeting that it would require 6 months to update its vaccine.
“This is a situation where Pfizer and Moderna have a clear advantage over Novavax because of the nature of the mRNA vaccines, which can be updated and manufactured more quickly,” said Cutrell.
Sellick said the shorter time required to update the mRNA vaccines may also result in a better match with circulating variants.
However, because new variants of the coronavirus continue to emerge throughout the year, there’s no guarantee that the variants targeted by the updated vaccine will match what is circulating after rollout.
“It’s definitely going to be a challenge,” said Sellick.
Annual COVID-19 vaccinations could be similar to flu shot schedule
The proposed yearly update would be similar to the process used to update the seasonal influenza vaccines.
Each year, certain flu strains become dominant and spread around the world. The flu vaccines are designed to target the strains expected to be in circulation.
The coronavirus, though, doesn’t follow the same pattern. Variants have arisen in different countries, with some driving waves in many countries, while other variants have remained more local.
In addition, the coronavirus hasn’t shown the same seasonality as the influenza virus, which starts to spread in the Northern Hemisphere each year in the fall.
Still, Cutrell said if there is going to be an annual COVID-19 vaccine, it makes sense to roll it out alongside the flu vaccine.
“This will help protect people through the winter when hospitals are going to be closer to capacity due to flu and other respiratory viruses,” he said.
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