FDA authorizes second coronavirus booster dose for people 50 and older
Tuesday’s announcement from the FDA also included an update for immunocompromised people. They are now also eligible for an additional booster. They initially received a series of three vaccinations and have already been eligible for a booster. Now they too can receive a second booster, which means they can receive a total of five injections.
There are approximately 118 million people age 50 and older in the United States. But since not everyone in this age group has received the first round of vaccines or booster shots, only a fraction are immediately eligible for a fourth vaccine.
Booster uptake in the United States has been slower than desired, especially among older Americans who are at higher risk of serious illness. About 15 million people aged 65 and over – a third of people in that age group – are fully vaccinated but have not received a first booster. Only about 40% of people aged 50 to 64 have received a first reminder.
“I urge people to get their first booster because one thing that has become clear…is that the third dose provides a different level of immunity that seems to give people an added benefit, in terms of prevention serious consequences of hospitalization and death – and it seems to last and be more durable,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, at a press conference.
The second booster for adults 50 and older and for immunocompromised people 12 and older should be available immediately after the Centers for Disease Control and Prevention makes a decision on who should get it.
The CDC is expected to say that people in this age group could receive a fourth vaccine, instead of an explicit recommendation to do so, reflecting the ongoing debate over the benefits of additional doses and uncertainties about the future of the pandemic.
Messenger RNA boosters will be available to people regardless of the brand of coronavirus vaccine they originally received, including Johnson & Johnson recipients. The Pfizer-BioNTech booster is licensed for immunocompromised individuals 12 years of age and older. The Moderna vaccine is not yet authorized for adolescents, and its booster is authorized for immunocompromised people aged 18 and over.
Experts, who have been inundated with questions from family members and emails from the public seeking advice, said they hoped the agency would give clear advice to help people and healthcare providers navigate the situation.
“I have received several requests from lay friends over the past few days: ‘What does this mean, and what should I do?’ said John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine in New York. “I find it increasingly difficult to tell my friends what to do. This is getting really problematic. »
The primary benefit of a fourth vaccine is thought to be protection against serious disease, and this risk can vary significantly among people age 50 and older. Not all experts are convinced the benefits are clear, and some have debated whether the age limit should be 60 or older. A matrix of factors – including underlying health conditions, age and time since last booster dose or infection – could play a role in what a person should consider in terms of risk per compared to the benefits.
A 70-year-old with diabetes and high blood pressure, for example, who received a booster dose in October would likely be at a radically different risk of covid-19 than a 50-year-old without a medical condition on -lying. Tens of millions of people were infected with the omicron variant during the winter surge, and these people’s immune systems were effectively boosted – so they may not need another injection now.
Some experts have expressed concerns about the decision-making process. The second recall issue is not expected to be presented to outside FDA and CDC advisory committees.
“I think it’s wonderful that the FDA is doing [a second booster] available,” said William Schaffner, an infectious disease expert at Vanderbilt University and liaison member of the CDC’s Advisory Committee on Immunization Practices. But Schaffner said such decisions are typically reviewed by CDC advisers, “and I think that mechanism should have been used for that as well.”
Even though outside experts have come to a similar conclusion, having a discussion and seeing data presented in a public meeting provides transparency and a “different tone,” Schaffner said.
But the FDA news will certainly be welcome for a segment of the population “who will be at their doctor’s or pharmacy tomorrow, if not this afternoon, getting their fourth dose,” Schaffner said. “But they will be the minority of the population because after all, before you get your fourth, you have to get your third,” Schaffner said.
The evidence supporting a fourth dose is limited and mixed, based largely on data from Israel – where people aged 60 and over were able to receive a second booster shot. Israeli studies have supported the idea that an additional injection could save the lives of people over 60, but have also suggested that injections will only have marginal benefits for young and healthy people and will not only provide modest, short-term protection against infection.
A preliminary study in Israel found a 78% reduction in deaths among people over 60 who received a fourth injection, compared to those who received only three injections. Another preprint found a lower rate of severe illness among people over 60 who received four injections, but was limited, covering only a two-week period in late January.
Data included in a letter to the editor from the New England Journal of Medicine provided a more mixed picture. Among healthcare workers in Israel, a fourth hit has increased antibodies blocking the virus. But that boost offered little protection against infection, and those infected showed few symptoms whether they received three or four injections. Vaccinated people had relatively high amounts of virus in their noses, suggesting they could transmit the infection to others.
The Israeli data highlighted that the effects of boosters are transient and that a fourth dose strategy is a short-term approach. A preliminary Israeli study published last week ahead of peer review found that a fourth dose protected 73% against severe disease compared to three doses over 10 weeks of follow-up. But protection against infection was modest and short-lived, peaking at 64% three weeks after vaccination and falling to around 29%.
Marks acknowledged that data supporting a fifth dose for immunocompromised people was more limited, but said it was seen as a way to protect vulnerable people. Vaccines tend to generate weaker protection against covid-19 in this group of people and tend to erode faster.
Timing the maximum protection of injections when the virus risk is highest is tricky. No one knows when future variants will appear, and scientists are uncertain even of known threats. Infections of the BA.2 version of the omicron variant are increasing in the United States, but some health officials have said they do not expect BA.2 to cause an outbreak. Some experts predict a surge next winter.
As for giving a second reminder, Moore said, “Do you have to do it now – and in the fall? Or in the fall — and not now? This is where it turns heads. What is the long-term intention and what is the long-term policy? »
Regardless of Tuesday’s action, the FDA plans next week to convene outside advisers to discuss the long-term booster dose strategy for the general population. One possible scenario, Marks said, is a fall recall campaign that coincides with annual flu shots.
Vaccine makers are working on shots they believe will provide longer-lasting protection. In recent days, executives from Pfizer and its German partner BioNTech and Moderna have indicated they believe new versions of their vaccines, including formulations incorporating two versions of the coronavirus, will create longer-lasting immunity.
“I think about my family – my loved ones and what I would say. … I would probably tell them to hold back until there’s clear evidence of an increase in their field,” said Natalie Dean, a biostatistics expert at Emory University’s Rollins School of Public Health. in Atlanta. “There’s something about the timing – and where the numbers stay low and they were bumped up not so long ago, a few months ago, I wouldn’t go out and tell them they’re in. need right now.”
Dan Keating and Lena H. Sun contributed to this report.