Federal agencies OK new annual vaccine for COVID, ‘bridge’ funding for uninsured

Enterprise file photo — Michael Koff

Americans six months or older are being encouraged by the Centers for Disease Control and Prevention to get the new COVID vaccine, likened to an annual flu shot. Interest in the shots is now less intense than it was near the start of the pandemic when vaccines, like this one given to Elaine Roper, were administered in the Knox Town Hall.

ALBANY COUNTY — As the fall viral season looms, large pharmacy chains are expected to have new shots for COVID-19 available by the end of this week.

Many pharmacies are already giving flu shots and have vaccine for respiratory syncytial virus, known as RSV, available for people 60 or older.

On Monday, the Food and Drug Administration approved the new COVID shots made by Pfizer-BioNTech and Moderna, both messenger RNA vaccines. And on Tuesday, the Centers for Disease Control and Prevention recommended everyone six months or older get shot, which was formulated to combat recent strains, similar to annual flu shots.

The updated COVID-19 vaccines are “formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death,” said the FDA in a news release on Monday.

In January, the Food and Drug Administration said it would annually assess the SARS-CoV-2 evolution, starting data review each spring, to decide on strain selection for a fall vaccination.

After analyzing data, the FDA advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition.

Some virologists are now concerned that a new variant, BA.2.86, is so different that it could bypass the protection the new annual shot is meant to provide. Tests results on the new shot’s effectiveness against BA.2.86 are not yet available.

However, in its Monday release, the FDA said, “In studies that have been recently conducted, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection.”

It concludes, “This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.”

Estimates from the CDC show EG.5 remains the dominant sublineage of Omicron in the United States, at 21.5 percent of new cases, followed by FL.1.5.1 at 14.5 percent, and XBB.16.6 at 9.2 percent.

In our region, which includes New York, New Jersey, Puerto Rico, and the Virgin Islands, the dominant sublineage is the fast-growing FL.1.5.1 at 27. 9 percent followed by EG.5 at 19.6 percent — after which are several sublineages of the once-dominant XBB.

In New York state, according to the state’s health department, with data last updated on Sept. 6, the Omicron sublineage XBB.1.9 is dominant at 47.8 percent of new cases statewide, followed by XBB.1.16 at 24 percent and XBB.1.5 at 14.1 percent.


Who is eligible?

The FDA on Monday listed who is eligible for the new shot:

— People age 5 and older regardless of previous vaccination can get a single dose of an updated messengerRNA COVID-19 vaccine at least two months since the last dose of any COVID-19 vaccine;

— Children aged 6 months through 4 years old who have previously been vaccinated against COVID-19 can get one or two doses of an updated mRNA COVID-19 vaccine with timing and number of doses dependent on the previous COVID-19 vaccine received; and

— Children 6 months through 4 years old who have never been vaccinated can receive three doses of the updated authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 vaccine.

“The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks,” the release said.

Side effects will be similar to those from the earlier mRNA vaccines, said the FDA, adding, “Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.”

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The FDA went on to cite is evaluation of manufacturing data supporting the 2023-24 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component.

The FDA also says, “Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”



While in previous years, the United States government paid for COVID shots, the federal emergency ended in May. Medicare and private insurers are now expected to pay for the shots.

In July, the CDC said it would launch a “Bridge Access Program” this fall “to help ensure that millions of uninsured and underinsured American adults continue to have access to no-cost COVID-19 vaccinations.’

A July 13 release from Health and Human Services said, “There are an estimated 25-30 million adults without insurance in the U.S., and there are additional adults whose insurance will not provide free coverage for COVID-19 vaccines after these products transition to the commercial market for procurement, distribution, and pricing, later this fall.”

HHS went on, “Under the management and oversight of CDC, the Bridge Access Program – for a limited time – will allow adults who are uninsured or underinsured to receive free COVID-19 vaccinations.”

The CDC will purchase COVID-19 vaccines and allocate them, along with the funding needed to implement this new program, through the CDC’s established network of state and local immunization programs, HHS said; to broaden access, the CDC is also working closely with select national pharmacy chains, as well as vaccine manufacturers, to enable uninsured adults to receive free COVID-19 vaccines at participating retail pharmacy locations.

The bridge program is scheduled to end in December 2024.

“Protecting people from COVID-19 remains a top priority for CDC,” CDC Director Dr. Mandy Cohen said in the HHS release. “CDC is partnering with state and local public health agencies, health centers, and pharmacies to ensure that all adults nationwide maintain access to lifesaving COVID-19 vaccines.

“Ultimately, we know that vaccines save money and lives. Vaccination is especially important as we head into fall and winter, a time when COVID-19 and other respiratory diseases are likely to circulate.”



The new vaccines are being released amid reports of the new variant — BA.2.86 has now been detected in New York state — and following a rise in COVID-19 cases and hospitalizations this summer.

In Albany County, 29 people were hospitalized with confirmed cases of COVID-19 in the past week, down 19 percent from the prior week, according to the Centers for Disease Control and Prevention.

That compares with 36 people hospitalized with confirmed cases of COVID-19the week before in Albany County, up 80 percent from the prior week.

The most recent data on the CDC site, through Sept. 2, shows hospital admission with COVID-19 at 5.8 per 100,000 of population, which is considered “low” well below the threshold of 10 per 100,000.

A new sublineage of the Omicron variant, BA.2.86 has the potential of escaping the antibodies that protect people from getting sick — even if people have been recently infected or vaccinated.

In an Aug. 23 risk assessment, the CDC says, “Based on what CDC knows now, existing tests used to detect and medications used to treat COVID-19 appear to be effective with this variant. BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines.”

The vast majority of counties across the nation and in New York state — including Albany County — are labeled by the CDC as currently having “low” rates of hospitalization for COVID-19.

The CDC also maps the deaths due to COVID-19 in the last week. New York is one of eight states — the others are Pennsylvania, Massachusetts, Tennessee, Florida, Texas, Arizona, and California —to have between 2.0 and 3.9 percent of its deaths due to COVID-19; all of the other states have lower rates.

As of Sept. 6, New York state had 2.2 percent of its deaths over the last week from COVID, an increase of 4.8 percent from the week prior.

The national average is 2.1 percent, a 105 percent increase from the week prior.


Albany County

The latest update on Albany County’s wastewater surveillance, a way of tracking COVID infections since the stringent mechanisms for reporting test results have fallen by the wayside, was filed on Sept. 8.

The report shows the Guilderland wastewater plant along with the North and South plants in Albany each with an “increasing” two-week trend. Guilderland and the North Plant, which serves Cohoes, Guilderland, Colonie, Green Island, Watervliet, and the North End of Albany, are both lower than the statewide rate but the rate from the South Plant, which serves the majority of the city of Albany, is higher.

The fourth wastewater plant participating in the program, in Bethlehem, had a decreasing two-week trend but a rate higher than statewide. However, only Guilderland had its quality control assessed as “good.”

Albany County, now in its 183rd week of dealing with the virus, still advises on its website that residents stay up to date with vaccines.

The numbers for vaccination in Albany County have hardly budged since May. The state’s dashboard now reports on these two categories:

— People with a primary series, for those who have completed the recommended initial series of a given COVID-19 vaccine product — two doses of Pfizer or Moderna vaccine or one dose of Johnson & Johnson vaccine; and

— People who are up to date, for those who have completed all COVID-19 vaccinations, including the bivalent booster, as appropriate per age and clinical recommendations.

As of Tuesday, 23.9 percent percent of Albany County residents were up to date on vaccines, a gradual increase from 17.9 in February.

At the same time, 76.8 percent of county residents have completed a primary series, up slightly from 76.3 percent in May.

This compares with 77 percent of New Yorkers statewide completing a vaccination series, and 15.5 percent being up to date with vaccinations, up from 10.6 percent in February.

Some experts have estimated that vaccinating Americans of all ages could reduce the number of hospitalizations and deaths by 20 percent.

More Regional News

The Altamont Enterprise is focused on hyper-local, high-quality journalism. We produce free election guides, curate readers' opinion pieces, and engage with important local issues. Subscriptions open full access to our work and make it possible.