With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different.
In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention and the Food and Drug Administration detailed the various countermeasures available to combat Covid-19, RSV, and influenza, and discussed the expected timing on the rollouts of these tools. They spoke on condition that their names and titles would not be disclosed.
“We are in our strongest position yet to be able to fight Covid-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations,” one CDC official said. “We also have more tools, including … for the first time ever, vaccines for all three of the major fall and winter respiratory viruses — influenza, Covid, and RSV. Our goal, our imperative, our task is to make sure we’re using those tools.”
The updated Covid vaccines have not yet been cleared by the FDA, but that must be coming in the next two and a half weeks or so, because a meeting of the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, has been slated for Sept. 12. ACIP must vote on whether to recommend the updated vaccines — and the recommendation must be endorsed by CDC Director Mandy Cohen — before they can begin to be used. The federal officials said the vaccine rollout would begin by mid-September.
The Covid vaccines will once again be monovalent, targeting a single strain of the SARS-CoV-2 virus. They will be the first not to include the original version of the SARS-2 virus that emerged in late 2019.
The two messenger RNA vaccines, made by Moderna and the Pfizer-BioNTech partnership, are fully authorized vaccines for people aged 12 and older. Those two vaccines will be available under an emergency use authorization for children 11 years old and younger, as will the Novavax vaccine, which is authorized for use in people 12 and older.
This year, as last, older adults and people who have immunocompromising health conditions will be able to get a second dose of vaccine, an FDA official said.
“We have built into the vaccination program moving forward that older individuals and those with immunocompromise might need to get more than one vaccine and in particular for people over 65 that a second vaccine a few months after the initial dose may be a reasonable thing to do at the discretion of the healthcare provider,” he said.
The FDA authorized what became known as a spring booster earlier this year for people in these population categories. At the time, it was recommended that people wait at least four months before having the second booster; the recommended interval was two months for people who were immunocompromised. Extra doses were available, a report from the CDC said, based on “the clinical judgment of a health care provider, a person’s risk for severe Covid-19 because of the presence of underlying medical conditions and age, and personal preference and circumstances.”
When the extra dose was announced this spring, it seemed to be a one-off. But it appears, based on the FDA official’s comments, that it will be the regulatory policy going forward. While ACIP members verbally supported the move during a meeting in April, they never actually took a vote endorsing an extra dose, a move that would likely be needed in order to ensure insurance coverage. Insurance providers are obliged to cover the cost of vaccines that the ACIP has recommended.
When asked whether this fall’s booster would work against the new subvariant, BA.2.86, that has recently been found in a number of countries, the FDA official echoed a statement issued Wednesday by the CDC, saying there hasn’t been time yet to conduct the needed tests.
“We’ll obviously have more data that will come in in the next few weeks. But for right now I think we believe the booster will be helpful against the severe outcomes that might occur,” he said.
New to the public health armamentarium this year are tools to combat RSV — respiratory syncytial virus. Two vaccines for older adults were approved in May, and a monoclonal antibody for newborns, Beyfortus, was approved earlier this summer. Beyfortus was developed by AstraZeneca and is marketed in the United States by Sanofi.
A Pfizer vaccine for pregnant people — given to protect their babies after they are born — was approved earlier this week by the FDA. As with the Covid vaccines, the ACIP must recommend it before it can be put into use. The timing of a meeting to vote on whether to recommend it has not yet been set, but the CDC official said it will likely occur in September.
On the issue of the availability of Covid tests, on official from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response said the federal government still has significant supplies of tests that it is shipping to schools, libraries, long-term care facilities, and other distribution points.
“We have no intention to stop that anytime soon so those tests will also be out there,” he said, adding that distributing tests through the U.S. Postal Service “is a lever we still have available to us if we choose to [use it].”