Booster Shots a Likely Reality for COVID-Vaccinated Americans

FRIDAY, April 16, 2021 (HealthDay News) -- Vaccinated Americans will probably need booster shots to guard against emerging coronavirus variants in the future, a White House adviser and Pfizer's CEO said Thursday.

The United States is already planning for future booster shots, Dr. David Kessler, chief science officer for the pandemic response, said during a House subcommittee hearing on the country's vaccination efforts.

And in remarks released Thursday, Pfizer CEO Albert Bourla said the most likely scenario included the need for a third vaccine dose six to 12 months after initial inoculation, after which "there will be an annual revaccination."

"There are vaccines like polio where one dose is enough, and there are vaccines like flu that you need every year, " Albert Bourla, the Pfizer chief, said in a conversation hosted by CVS Health, CNBC News reported. "The COVID virus looks more like the influenza virus than the polio virus."

In February, Pfizer said it was testing a third dose of its COVID-19 vaccine to understand the immune response against new variants of the virus. And Moderna said this week that it was at work on a booster for its vaccine, while Johnson & Johnson has said that its single-shot vaccine will probably need to be given annually, The New York Times reported.

Kessler, who runs the Biden administration's vaccine effort, told the House subcommittee that the government was looking ahead, the Times reported. While he emphasized the "strong efficacy" of the current vaccines, including against the new variants, he said the government was "taking steps to develop [the] next generation of vaccines that are directed against these variants if in fact they can be more effective."

He was one of several top health officials at the subcommittee hearing who implored Americans to get vaccinated and sought to reassure the country that all three federally authorized vaccines are safe. However, they said little about restarting distribution of J&J's shots, which the U.S. Food and Drug Administration has paused to examine a handful of clotting cases in those who got the vaccine.

Late Thursday, the U.S. Centers for Disease Control and Prevention said it had scheduled a new emergency hearing on the safety of J&J's for April 23.

As of Thursday, more than 125 million people in the country had received at least one dose of a COVID-19 vaccine, including over 78 million who have been fully vaccinated.

Johnson & Johnson COVID vaccine in limbo after clotting reports

The fate of Johnson & Johnson's coronavirus vaccine hangs in the balance after a government advisory committee said it needed more time and evidence to determine whether unusual, but severe, blood clots seen in a handful of people were caused by the vaccine.

So far, only six clotting cases have been officially reported out of more than 7 million shots given of the one-dose vaccine. But on Tuesday, U.S. health officials recommended a pause in J&J vaccinations.

On Wednesday, advisers to the U.S. Centers for Disease Control and Prevention held an emergency meeting to look at the evidence and decided they did not have enough information or time to recommend how to proceed, the Associated Press reported. A second emergency hearing has been scheduled for next week.

But some vaccine specialists who watched the deliberations said the public shouldn't have to wait for more advice.

"What they did was they punted," Dr. Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, told the AP. "I just don't think waiting is going to give you a critical amount of information that is going to help you make a decision."

But the CDC advisors stressed they need to proceed carefully.

"I continue to feel like we're in a race against time and the variants, but we need to [move forward] in the safest possible way," said CDC adviser Dr. Grace Lee, of Stanford University, who was among those seeking to postpone a vote on the vaccine, the AP reported.

Authorities have studied the clots for only a few days and have little information to judge the shot, said fellow CDC adviser Dr. Beth Bell, from the University of Washington, the AP reported.

"I don't want to send the message [that] there is something fundamentally wrong with this vaccine," Bell said. "It's a very rare event. Nothing in life is risk-free. But I want to be able to understand and defend the decision I've made based on a reasonable amount of data."

One of the most worrying things about the clots is that they atypical and require different treatment. They occur in unusual places, such as in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets, the AP reported. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see of more typical clots, said the CDC's Dr. Tom Shimabukuro.

"What we have here is a picture of clots forming in large vessels where we have low platelets," Shimabukuro explained to the AP. "This usually doesn't happen," but it is eerily similar to European reports of clotting with the AstraZeneca vaccine.

The J&J clotting cases in the United States were all among women younger than 50. In Europe, most but not all cases following AstraZeneca vaccinations have been among women under 60, leading different countries to deploy that vaccine in more limited ways.

Also, a 25-year-old man experienced a similar clot during U.S. testing of J&J's vaccine, something the government scrutinized at the time but could not link to the shot. And on Wednesday, the company also brought to the CDC's attention a woman whose clot did not occur in the brain, the AP reported. So far, the clots have occurred between one and three weeks after people received the J&J vaccine, and officials cautioned that more reports could surface, the AP reported.

Antibody cocktail offers protection

People living with someone who has COVID-19 appear to get powerful protection against infection when they are given Regeneron's antibody cocktail, a new study shows.

The findings suggest that beyond preventing the worst outcomes for coronavirus infection when given early enough, the cocktail could also prevent people from getting sick in the first place, the company said earlier this week.

"With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus, and we are also working to understand its potential to provide ongoing protection for immunocompromised patients who may not respond well to vaccines," Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.

There's "a very substantial number of people" in the United States and globally who could be a good fit to receive these drugs for preventive purposes, Dr. Myron Cohen, a University of North Carolina researcher told The New York Times. He leads monoclonal antibody efforts for the Covid Prevention Network, a U.S. National Institutes of Health-sponsored initiative that helped oversee the Regeneron trial.

"Not everyone's going to take a vaccine, no matter what we do, and not everyone's going to respond to a vaccine," Cohen noted.

The new data on Regeneron's antibody cocktail comes from a clinical trial that enrolled more than 1,500 people who lived in the same house as someone who had tested positive for the virus within the previous four days. Those who got an injection of Regeneron's drug were 81 percent less likely to get sick with COVID-19 compared to volunteers who got a placebo, the company said.

Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital who was not involved in the study, told the Times that the data were "promising" for people who have not been vaccinated. But he noted that the type of patients that would be needed to determine whether the drug should be used preventively for immunocompromised patients were not included in the trial. "I would say we don't yet know that," Gandhi said.

The treatment received emergency authorization last November. Doctors are using it, as well as another antibody cocktail from Eli Lilly, for high-risk COVID-19 patients, to guard against severe disease and hospitalization.

But many hospitals and clinics have not made the treatments a priority because they are time-consuming and difficult to administer, mostly because they must be given intravenously. Regeneron plans to ask the FDA to allow its drug to be given via an injection, as it was in the latest study, which would allow it to be given more quickly and easily.

The U.S. coronavirus case count passed 31.5 million on Friday, while the death toll neared 565,000, according to a Times tally. Worldwide, more than 139.2 million cases had been reported by Friday, with nearly 3 million dead from COVID-19.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

SOURCES: The New York Times; Associated Press