The Food and Drug Administration on Tuesday approved an extra dose of the Pfizer or Moderna vaccine for this age group and for some younger people with severely weakened immune systems. The Centers for Disease Control and Prevention later recommended the extra shot as an option, but stopped urging those eligible to rush out and pick it up immediately. This decision extends the additional aid to millions more Americans. Dr. Rochelle Walensky, director of the CDC, said it was especially important for older Americans – aged 65 and over – and 50 people with chronic illnesses such as heart disease or diabetes to consider another shot. “They are most likely to benefit from taking an extra booster at this time,” Walensky said. There are indications that protection may be particularly weak in high-risk groups, and for them another booster “will help save lives,” said Dr. Peter Marks, head of FDA vaccines. Despite attention to who should get a fourth dose of Pfizer and Moderna vaccines, only about half of Americans eligible for a third vaccine have done one – and the government has urged them to stay informed. Two shots plus a booster still offer strong protection against serious illness and death, even during the winter outbreak of the super-contagious omicron variant. The move to additional amplifiers comes at a time of great uncertainty, with limited evidence showing how much benefit an extra dose can offer at this time. COVID-19 cases have dropped to low levels in the United States, but all vaccines are less potent than newer mutants from earlier versions of the virus – and health officials are watching one Omicron brother cause alarming jumps in infections in other countries. Pfizer had asked the FDA to make a fourth installment for people 65 and older, while Moderna asked for another installment for all adults “to give flexibility” to the government to decide who really needs it. FDA Marks said regulators set the age at 50, because then chronic diseases that increase the risks of COVID-19 become more common. Until now, the FDA had only allowed a fourth dose of the vaccine for immunosuppressed people up to 12 years old. Vaccines are more difficult to rejuvenate a very weak immune system, and Marks said their protection also tends to weaken earlier. Tuesday’s decision also allows them another reminder – a fifth installment. Only the Pfizer vaccine can be used in people up to 12 years of age. Moderna’s is for adults. What about people who have been vaccinated with a single dose of Johnson & Johnson? They were already eligible for an amplifier of any kind. Of the 1.3 million who received the second J&J vaccine, the CDC has now said that they can choose a third dose – either Moderna or Pfizer. For the more than 4 million who received Moderna or Pfizer as a second vaccine, the CDC says an extra booster is only needed if they meet the latest criteria – a severely weakened immune system or are over 50 years old. This is because a CDC study that looked at which amplifiers were initially chosen by J&J recipients concluded that a second dose of Moderna or Pfizer was higher than a second dose of J&J. If the new recommendations sound confusing, outside experts say it makes sense to consider additional protection for the most vulnerable. “There may be a reason to fill the tanks a little” for the elderly and those suffering from other conditions, said University of Pennsylvania immunologist E. John Warry, who did not comment on the government’s decision. But while encouraging older friends and relatives to follow the advice, 50-year-old Wherry – who is healthy, vaccinated and refreshed – does not intend to get a fourth vaccine right away. With serious illness protection still strong, “I will wait until there is a need.” While protection against milder infections naturally decreases over time, the immune system builds multiple layers of defense and the formula that prevents serious illness and death endures. During the US micron wave, two doses were nearly 80% effective against the need for a respirator or death – and one booster boosted that protection to 94%, the CDC recently reported. The effectiveness of the vaccine was lower – 74% – in immunocompromised individuals, the vast majority of whom had not received a third dose. To evaluate an additional amplifier, US officials turned to Israel, which opened a fourth dose to people 60 and older during the micron surge. The FDA said no new safety concerns were raised in the review of the 700,000 fourth installments. Preliminary data posted online last week suggest some benefit: Israeli researchers counted 92 deaths among more than 328,000 people receiving the additional vaccine, compared with 232 deaths among the 234,000 who missed the fourth dose. What is not at all clear is how long any additional benefit from another amplifier will last and, therefore, when you will get it. “When ‘is a really difficult part. “Ideally, we could use booster doses just before the surges, but we do not always know when this will happen,” said Dr William Moss, a vaccine specialist at the Johns Hopkins Bloomberg School of Public Health. In addition, a longer interval between shots helps the immune system develop a stronger, more cross-defense. “If you get a souvenir very close to each other, it does not hurt – you just are not going to benefit much from it,” Wherry said. The latest boost may not be the last: Next week, the government will hold a public meeting to discuss whether everyone eventually needs a fourth dose, possibly in the fall, of the initial vaccine or an updated dose. Even if the Americans at higher risk are stepping up now, Marks said another dose may be needed in the fall if regulators decide to modify the vaccine. For this effort, studies in individuals – for small-scale shooting alone or in combination with the original vaccine – are ongoing. The National Institutes of Health recently examined monkeys and found “no significant advantage” in using a micron-only amplifier.
AP reporter Mike Stobbe contributed to this report.
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