Infectious Disease

‘Train has left the station’ on COVID-19 boosters despite questions

September 01, 2021

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Healio interview.

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Schaffner does not disclose any relevant financial information.

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As COVID-19 continues to rise in the United States, hospital admissions, deaths, and capacity problems in hospitals have increased across the country.

CDC director Rochelle P. Walensky, MD, MPH, said Tuesday that the U.S. averaged around 129,000 new cases and 11,500 hospitalizations of COVID-19 per day over the past week. These were declines from the previous week, but the infections are still occurring at levels not seen since winter and well above last summer’s high.

vaccination

More people may soon have access to COVID-19 booster vaccinations. Source: Adobe Stock

Given these increased case numbers, and despite the fact that the FDA has only approved third doses of the COVID-19 vaccine for immunocompromised people, the Biden government announced last month that the US will offer booster doses to all fully vaccinated Americans starting September 20 will .

William Schaffner

“Although the FDA has not yet approved the booster, and the CDC’s advisory committee” [on Immunization Practices (ACIP)] Has not made any recommendations yet, so much publicity has been given that boosters are already being given. Wilhelm Schaffner, MD, Professor of Preventive Medicine and Infectious Diseases at Vanderbilt University Medical Center and a member of the editorial board of Infectious Disease News, said Healio. “Some patients go to vaccination centers on their own and ask and get them, and there are already doctors out there who get all kinds of questions about it.”

“It’s not that dangerous,” said Schaffner, “but it definitely indicates that the train has left the station.”

Safe and effective, but not approved

In the summer, discussions began about offering booster doses of the COVID-19 messenger RNA vaccines to immunocompromised people. The data show that a third dose is safe for this population that does not respond optimally to vaccination, with side effects being local and short-term compared to the first and second doses.

“It doesn’t look like it [post-booster vaccination reactions] are worse, and that’s very, very comforting, “Schaffner said, adding that those doses also produce a” very lively, big antibody response. “

Third doses are only available to certain immunocompromised patients, especially recipients of solid organ transplants or those diagnosed with conditions considered to be equivalent.

Many uncertainties remain and are likely to remain for some time, Schaffner said, even if third doses actually help protect people from serious illness and continue to keep people out of the hospital and protect against serious illness, and whether they have any impact on breakthrough infections.

A complicated process

According to Schaffner, getting the FDA green light for the booster doses will be even more complicated than approving the first emergency vaccines.

He stated that no new formulations were proposed to the FDA, meaning that all approved boosters would be the same vaccine formulations. To make matters worse, two types of vaccines are used, Johnson & Johnson’s single-dose adenovirus-based vaccine and the two mRNA vaccines, which need to be treated separately. Schaffner said this will raise more questions in the future, how do people who received the Johnson & Johnson vaccine get another dose of it or do they get a dose of mRNA vaccine?

In Europe, experts have already begun to take steps to address this issue by giving patients who have received the AstraZeneca vaccine, similar to the Johnson & Johnson vaccine, their first and only dose of the vaccine, followed by a dose of mRNA -Vaccine, said Schaffner.

“Are we going to do something like this here?” he asked. “The ACIP would need data to confirm this, as would the FDA, and I don’t know if we will have enough data to confirm this.”

The process is made even more difficult by the fact that vaccine manufacturers have started work on variant-specific vaccines and boosters.

Booster and Variants

The Delta variant has established itself as the dominant SARS-CoV-2 strain in the USA, which raises questions about vaccine effectiveness. Data recently published in an MMWR suggest that the vaccines against Delta are less effective but still protect against serious illness.

Schaffner said it was difficult to “divide” whether the reduced protection was due to social behavior or the delta variant.

Manufacturers are working on variant-specific vaccines and could submit data to the FDA on newly engineered vaccines and even candidates that are combined with flu vaccines, Schaffner said.

“We may see all sorts of interesting options that are not currently available to us,” he said.

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