Tuesday’s FDA announcement also included an update for people with compromised immune systems. You are now also entitled to an additional booster. They initially received a series of three vaccinations and were already eligible for a booster shot. Now they too can get a second booster, meaning they can get a total of five shots.
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There are approximately 118 million people ages 50 and older in the United States. However, because not all people in this age group have received their first series of vaccinations or booster shots, only a fraction are immediately eligible for a fourth vaccination.
Uptake of booster shots in the United States has been slower than desired, particularly among older Americans who are at higher risk of serious illness. About 15 million people aged 65 and over – a third of people in this age group – are fully vaccinated but have not had their first booster shot. Only about 40 percent of people between the ages of 50 and 64 have received a first booster shot.
“I would urge people to get their first booster shot because one thing that has become apparent … is that the third dose provides a differentiating level of immunity that seems to offer people an added benefit in relation to the.” Preventing the serious consequences of hospitalization and death — and that appears to be lasting and more durable,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a news conference.
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The second booster shot for adults 50 and older and for immunocompromised individuals 12 and older is expected to be available immediately after the Centers for Disease Control and Prevention decides who should receive it.
The CDC is expected to say people in the age group may get a fourth shot, rather than specifically recommending it, reflecting the ongoing debate about the benefits of additional doses and uncertainties about the future of the pandemic.
The BA.2 “Stealth” Omicron variant is expected to become the dominant strain soon. Here’s what you need to know about a possible new wave of infections. (Video: Brian Monroe, John Farrell/The Washington Post, Photo: The Washington Post)
The Messenger RNA boosters will be available to people regardless of what brand of coronavirus vaccine they originally received, including Johnson & Johnson recipients. The Pfizer BioNTech Booster is approved for people aged 12 and over who have a weakened immune system. The Moderna vaccine has not yet been approved for teenagers, and its booster dose is approved for immunocompromised people aged 18 and over.
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Experts, inundated with questions from family members and emails from the public seeking advice, said they hoped the agency would provide clear guidance to help people and healthcare providers navigate the situation.
“In the past few days, I’ve had several requests from lay friends: ‘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’m finding it increasingly difficult to tell friends what to do. It’s going to be really problematic.”
It is believed that the main benefit of a fourth vaccination is protection against serious diseases, and this risk can vary dramatically in people over 50. Not all experts are convinced that the benefits are clear, and some have debated whether the age limit should be 60 or older. A matrix of factors — including underlying medical conditions, age, and time since last booster shot or infection — could play a role in what an individual should weigh in terms of risk and benefit.
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A 70-year-old with diabetes and high blood pressure who received a booster dose in October, for example, would likely have a dramatically different risk from Covid-19 than a 50-year-old with no underlying health problems. Ten million people were infected with the Omicron variant during the winter flood, and those people’s immune systems were effectively boosted – so they may not need another vaccination now.
Some experts have raised concerns about the decision-making process. There are no plans to submit the second edition of Booster to external FDA and CDC advisory committees.
“I think it’s wonderful what the FDA is doing [a second booster] available,” said William Schaffner, an infectious disease expert at Vanderbilt University and a liaison member of the CDC’s Advisory Committee on Immunization Practices. But Schaffner said such decisions would normally be reviewed by the CDC’s advisers, “and I think that mechanism should have been used for that as well.”
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Even when outside experts came to similar conclusions, having a discussion and seeing data presented at a public meeting provides transparency and a “different tone,” Schaffner said.
But the FDA news will certainly be welcome to a segment of the population “who will be at their doctor’s office or pharmacy tomorrow, if not this afternoon, to get their fourth dose,” Schaffner said. “But they’re going to be the minority of the population because before you get your fourth, you have to get your third,” Schaffner said.
Evidence for a fourth dose is limited and mixed, based mostly on data from Israel — where people aged 60 and over could get a second booster shot. Israeli studies have supported the idea that an extra shot for people over 60 could be life-saving, but have also pointed out that the shots have little benefit for young, healthy people and offer only short-term and modest protection from infection.
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A preprint study from Israel found a 78 percent reduction in deaths among people over 60 who received a fourth vaccination compared to those who received only three vaccinations. Another preprint found a lower rate of serious illness in people over 60 who received four vaccinations, but it was limited, covering only a two-week period in late January.
Data from a letter to the editor of the New England Journal of Medicine provided a more mixed picture. A fourth vaccination increased virus-blocking antibodies in health care workers in Israel. But that boost provided little protection against infection, and people who became infected showed few symptoms, regardless of whether they received three or four shots. Vaccinated people had relatively high levels of virus in their noses, suggesting they could spread the infection to others.
The Israeli data underscored that the effects of booster shots are temporary and that a fourth-dose strategy is a short-term approach. An Israeli preprint study published ahead of the peer review last week found that a fourth dose protected 73 percent from major disease compared to three doses over the course of 10 weeks of follow-up. But protection from infection was modest and short-lived, peaking at 64 percent three weeks after vaccination and falling to about 29 percent.
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Marks acknowledged that the data supporting a fifth dose for immunocompromised people is more limited but said it was seen as a way to protect vulnerable people. Vaccines tend to produce weaker protection against Covid-19 in this group of people and tend to erode more quickly.
It is difficult to time the shots’ maximum protection at the time of greatest risk from the virus. No one knows when future variants will emerge, and scientists are unsure even about known threats. Infections from the BA.2 version of the Omicron variant are increasing in the United States, but some health officials have said they don’t expect BA.2 to cause a spike. Some experts are forecasting a surge next winter.
Regarding a second refresher, Moore said: “Should you do it now – and in the fall? Or in autumn – and not now? This is where it gets a headache. What is the long-term intent and what is the long-term policy?”
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Aside from Tuesday’s action, next week the FDA plans to convene outside consultants who will discuss the long-term booster dose strategy for the general population. One possible scenario, Marks said, is a fall booster campaign to coincide with annual flu shots.
Vaccine manufacturers are working on vaccines that they believe will provide more durable protection. In recent days, executives from Pfizer, German partner BioNTech and Moderna have said they believe new versions of their vaccines, including formulations containing two versions of the coronavirus, will create longer-lasting immunity.
“I’m thinking of my family – my loved ones and what I would say. … I would probably tell them to just hold off until there is 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. “Timing has something to do with it — and where the numbers remain low and they’ve been ramped up not too long ago, a few months ago, I wouldn’t go out and tell them they need that now.”
Dan Keating and Lena H. Sun contributed to this report.