WASHINGTON — Additional COVID-19 vaccine booster shots are not needed for the general population, leading scientists including two departing senior U.S. Food and Drug Administration officials and several from the World Health Organization (WHO) said in an article published in a medical journal on Monday.
The scientists said more evidence was needed to justify boosters. That view disagrees with U.S. government plans to begin offering another round of shots to many fully vaccinated Americans as soon as next week, contingent on approval from health regulators.
As COVID-19 cases caused by the Delta variant of the virus rise, President Joe Biden’s administration is concerned that infections among those already vaccinated are a sign that their protection is waning and has pushed boosters as a way to rebuild immunity.
The WHO has argued that the vaccines are still needed for first doses around the globe.
“Any decisions about the need for boosting or timing of boosting should be based on careful analyses of adequately controlled clinical or epidemiological data, or both, indicating a persistent and meaningful reduction in severe disease,” the scientists wrote in the Lancet medical journal.
The risk-benefit evaluation should consider the number of severe COVID-19 cases that boosting would be expected to prevent, and whether it is safe and effective against the current variants, they said.
“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” the scientists wrote.
Some countries have begun COVID-19 booster campaigns, including Israel, providing some of the data on which the Biden administration has made its case for additional shots.
The article’s authors included the FDA Office of Vaccines Research and Review Director Marion Gruber and Deputy Director Phil Krause, both of whom plan to leave the agency in the next several months.
They acknowledged that some individuals, such as those who are immunocompromised, could benefit from an additional dose.
Broader use of boosters may be needed in the future if there is waning immunity to the primary vaccination or if new variants evolve so that the vaccines no longer protect against the virus, they said.
Boosters could also prove risky if introduced too soon or too frequently, the scientists wrote.
A panel of experts that advises the FDA on vaccines plans to meet on Sept. 17 to discuss additional doses of the Pfizer/BioNTech shot, the first step in a wider booster roll-out.
The article’s authors included WHO top scientists Soumya Swaminathan, Ana-Maria Henao-Restrepo and Mike Ryan.
“Current vaccine supplies could save more lives if used in previously unvaccinated populations,” the authors wrote.
Japan to double COVID-19 vaccine donations to other countries to 60 mln doses
TOKYO — Japan plans to give other countries 60 million doses of COVID-19 vaccines, Prime Minister Yoshihide Suga said on Thursday, doubling the target from the previous pledge of 30 million doses.
“Today, I am pleased to announce that, with additional contributions, Japan will provide up to approximately 60 million doses of vaccine in total,” Suga said in a pre-recorded video message at the U.S.-hosted Global COVID-19 Summit.
Of the first 30 million, Japan has already provided about 23 million doses mostly to Asian destinations including Taiwan, Vietnam and Indonesia.
Japan initially lagged behind other industrialised nations in its vaccination rollout, but now 55% of its population are fully vaccinated, roughly on a par with the United States.
Earlier this month, in a surprise announcement, Suga said that he was stepping down as prime minister, ending a one-year term that has seen his support crumble as COVID-19 cases surged.
U.S. FDA clears Pfizer COVID-19 booster for older and at-risk Americans
The U.S. Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer Inc and BioNTech COVID-19 vaccine for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus.
The decision paves the way for a quick rollout of the booster shots as soon as this week for millions of people who had their second dose of the vaccine at least six months ago.
The change to the vaccine’s emergency use authorization will allow boosters for groups such as health-care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, FDA acting Commissioner Janet Woodcock said in a statement.
Pfizer had asked the FDA to expand its vaccine approval to include boosters for all people aged 16 and older and presented data last week to an outside FDA panel of advisers that it said showed waning immunity over time.
The panel voted against the proposition that boosters were needed by everyone but said evidence showed they were helpful to older people and those at high risk.
Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases (NFID), said the FDA’s statement was more expansive in who it included as eligible for boosters when compared to the panel’s recommendation.
“Very broad indeed, especially that ‘among others.’ That could essentially give the green light for giving boosters to a very substantial proportion of the previously vaccinated adult population,” said Schaffner, who serves as the NFID’s liaison to the Advisory Committee on Immunization Practices (ACIP) at the U.S. Centers for Disease Control and Prevention (CDC).
ACIP could vote Thursday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday.
“Tomorrow’s ACIP meeting at the CDC will be focused on turning this into an official recommendation for implementation,” said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.
The FDA authorization was “generally in line” with the advisory panel vote, said Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington and former chief scientist at the FDA.
“These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunizations,” he added.
President Joe Biden and eight top health officials including Woodcock announced in August the government’s intention to roll out booster shots for people aged 16 and older this week, pending approval by the FDA and CDC.
But the advisory panel said there was not enough evidence to support booster shots for that population and also sought more safety data. The FDA does not have to follow the advisory panel’s recommendation, but often does.
The agency could revisit the issue for a broader authorization in the future.
“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Pfizer chief Albert Bourla. The company had argued that boosters are needed for the general population.
Top FDA members have been split on the need for boosters for the general population, with Woodcock backing them while some of the agency’s senior scientists argued that current evidence does not support them.
Some countries, including Israel and Britain, have already rolled out COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and over 2 million people have already received a third shot, CDC data showed.
WHO’s Tedros wins German backing for second term
BERLIN — German Health Minister Jens Spahn backed a second term for World Health Organization chief Tedros Adhanom Ghebreyesus and called on other countries to support the former Ethiopian health minister ahead of a deadline this week.
“We invite partner countries to join us nominating DG (Director General) Tedros,” Spahn told Reuters. The support is significant as Germany is a major financial backer of the WHO.
Last week, sources told Reuters that Tedros looks set to run unopposed for a second term at the helm of the WHO as it tries to guide the world through its biggest health crisis in a century, even though he lacks the support of Ethiopia due to friction over the Tigray conflict.
He has steered the agency through several Ebola outbreaks as well as the COVID-19 pandemic, surviving savage criticism from the Trump administration for allegedly being “China-centric”.
Those criticisms were echoed in a Wall Street Journal editorial on Tuesday arguing against a second term.
“The White House is committing diplomatic malpractice by not working with allies and partners to back a credible alternative,” the newspaper wrote.
The WHO had no immediate comment on the issue.
While Tedros has not publicly acknowledged his plans to run again for a second five-year term, saying he was focusing on fighting the pandemic, four sources said he is the only known candidate.
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