US agency authorises Covid booster for vulnerable people
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US health officials have authorised a third dose of mRNA Covid-19 vaccines for immunocompromised adults to protect them from a wave of cases driven by the contagious Delta variant.
The booster of either the BioNTech/Pfizer or Moderna jab will be offered to a small group of people with weakened immune systems, such as organ transplant recipients, and will be administered at least 28 days after the original two-dose regimen is completed, the US Food and Drug Administration said in a statement on Thursday.
“The country has entered yet another wave of the Covid-19 pandemic, and the FDA is especially cognisant that immunocompromised people are particularly at risk for severe disease,” Janet Woodcock, acting FDA commissioner, said in a statement.
An advisory committee for the Centers for Disease Control and Prevention will meet on Friday to further discuss the issue.
Speaking to reporters at the White House earlier on Thursday, Rochelle Walensky, director of the CDC, said: “Emerging data show that certain people who are immune compromised, such as people who have had organ transplants and some cancer patients, may not have had an adequate immune response to just two doses of the Covid vaccine.”
“To be clear, this is a very small population,” she added. “We estimate it to be less than 3 per cent of adults.”
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The move comes as cases and hospitalisations from Covid-19 have increased due to the spread of the contagious Delta variant. The US reported 132,384 infections on Wednesday, Walensky said, bringing the seven-day average to about 113,000 cases, a 24 per cent increase from a week ago.
An average of 9,700 patients have been admitted to hospitals with Covid-19 each day over the past week, she said, a 31 per cent increase from a week ago.
The increases have been most notable in parts of the country where vaccinations have lagged behind, leading some officials to describe the current surge as a “pandemic of the unvaccinated”.
Earlier on Thursday Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told NBC News that “inevitably” everyone would need a third dose of vaccinations.
“No vaccine, at least not within this category, is going to have an indefinite amount of protection,” Fauci said. “Inevitably, there will be a time when we’ll have to give boosts.
“Right now at this moment, other than the immunocompromised, we’re not going to be giving boosters to people,” he added. “But we will be following them very carefully and if they do need it, we’ll be ready to give it to them.”
Fauci’s comments were underscored by Jeff Zients, the White House Covid-19 response co-ordinator, who said the US had enough vaccine supply and the infrastructure to quickly roll out booster shots should they be needed.
The Biden administration announced last month it had secured another 200m doses of the BioNTech/Pfizer Covid-19 vaccine, expanding its total order to 500m, as officials prepare for the next phase of vaccinations, including children under 12 and potential booster shots.
“If and when there is a decision, we are prepared,” Zients said on Thursday. “We have the supply and you will be able to get a booster in a fast and efficient way, if and when the science dictates.”
ABC News on Wednesday published internal CDC documents showing that an estimated 1m Americans had already received unauthorised third doses of Covid-19 vaccines.
Walensky, when asked about the reports, said the health officials were “asking people to follow our guidance, to follow what APIC [Association for Professionals in Infection Control and Epidemiology] will say and the FDA will say in the coming days, several days, and to follow recommendations”.
Additional reporting by Peter Wells in New York