3rd shot advised for the high risk
Fast CDC approval expected
A federal advisory panel to the Centers for Disease Control and Prevention voted unanimously Friday afternoon to recommend an additional dose of coronavirus vaccines for some immunocompromised people.
CDC Director Rochelle Walensky is expected to accept the vote and give final approval for the third shots within hours, paving the way for millions of moderately or severely immunocompromised people to get another dose of either the Pfizer-BioNTech or Moderna vaccines as soon as this weekend. That means those 12 and older who have immunity disorders would be eligible for Pfizer-BioNTech; the Moderna vaccine is for those 18 and older.
The CDC, in a presenta
tion to the panel, detailed for the first time which patients should consider the extra shots. They include people being treated for tumors or cancers of the blood; organ transplant patients, including those who have gotten stemcell transplants within the past two years, and those who have diseases that damage the immune system.
Also on the list are people with advanced or untreated HIV infection, those taking high-dose steroids, and those who have chronic medical conditions that can weaken immune response, such as chronic kidney disease. The CDC estimates that about 2.7% of U.S. adults are immunocompromised, or about 7 million people.
The reccomendation was made after the Food and Drug Administration announced late Thursday that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.
The CDC will not require patients to get a prescription or a letter from a doctor for the third shot, officials said. Consumers will have to attest only that they have impaired immune systems. The goal is to minimize barriers to vaccination, the officials said. Additional doses will be free and people will be able to get them in the same way they got earlier shots, through pharmacies and other health care providers.
TAKING PRECAUTIONS
Transplant recipients and others with suppressed immune systems know they’re at more risk than the average American and some have been seeking out extra doses on their own, even if it means lying about their vaccination status. The change means now the high-risk groups can more easily get another shot — but experts caution it’s not yet clear exactly who should.
“This is all going to be very personalized,” cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third dose “increases their immune response. Yet for some people it does not seem to. We don’t quite know who’s who yet.”
One recent study of more than 650 transplant recipients found just over half harbored virus-fighting antibodies after two doses of the Pfizer or Moderna vaccines — although generally less than in otherwise healthy vaccinated people. Another study of people with rheumatoid arthritis and similar autoimmune diseases found only those who use particular medications have very poor vaccine responses.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, cautioned the panel that additional doses appeared to be only “moderately effective” at bolstering protection for immunocompromised patients. He said they should be encouraged to continue following social distancing and other safety steps to reduce their chances of infection from the coronavirus.
Patients should talk to their doctors about the severity and duration of their immune issues, and whether they are taking medicine or doing other therapies that can lower their body’s response to vaccines.
Panel members stressed that the benefits of the third doses far outweighed the risks. Immunocompromised patients are more likely to become seriously ill from covid-19, the illness caused by the coronavirus; to transmit the virus to household contacts; and to have breakthrough infections. Once infected, these patients also can potentially harbor mutations that lead to more virulent new variants, experts say.
The panel urged patients getting a third shot of the same vaccine as their first two doses, unless the same vaccine is unavailable.
Advisers also noted the recommendation covers a small population unable to mount a full response, with several stressing the urgency of providing first doses to people around the world.
Studies have shown that many immunocompromised patients have a very weak or no responses to the vaccines, even after a full regimen. The FDA said that it evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna vaccines in these individuals and determined that the administration of third vaccine doses may increase protection against the coronavirus.
CDC officials said they will be posting additional detailed guidance for clinicians by the end of Friday.
NEED FOR BOOSTERS
Panel members also heard a CDC presentation on the framework needed to evaluate the potential need for boosters. The CDC will present more data over the next few weeks to assess whether boosters are necessary based on the durability of vaccine effectiveness, and whether certain at-risk groups, including older Americans and health care workers, should get them first. Israel has started administering booster doses to older people, and other countries are planning to do so.
The Biden administration officials appear increasingly convinced that boosters for the broader population will be necessary in the future. Officials are analyzing studies from Israel, the United Kingdom, and the pharmaceutical companies on the vaccines’ durability and which groups should get priority, according to federal officials who spoke on the condition of anonymity because they were describing internal discussions.
But panel members stressed the best way to control the pandemic is for the unvaccinated to get their shots. “We have very little evidence at this point that waning immunity is a significant driver of disease,” said Matthew Zahn, medical director for epidemiology at the Orange County Health Care Agency in California. “Right now, the overwhelming driver of disease — serious disease in particular — is people who aren’t vaccinated.”
Yvonne Maldonado, representing the American Academy of Pediatrics, called for vaccine companies to provide more data about the enduring strength of the vaccines in protecting against infection and illness, noting that companies have been collecting samples from volunteers since clinical trials began more than a year ago. “I really think that the companies really owe it to the public health infrastructure of the U.S. and elsewhere to find data,” she said. “That’s not hard science.”
FEAR OF VARIANT
Discussions have become increasingly urgent as the delta variant, which now makes up 97.4% of all new infections, wreaks havoc in many parts of the country and some studies indicate a waning of the vaccines’ protection over time, those officials said. Many vaccinated Americans have sought out extra shots because they fear their current doses don’t offer sufficient protection against a virus once again roaring through all 50 states.
It’s not clear how many people may have taken matters into their own hands. For Pfizer and Moderna recipients alone, the CDC estimates that 1.1 million have received additional shots, according to an internal document reported by ABC News. On Thursday, Walensky warned that such decisions undermine the CDC’s safety monitoring since they make it harder to track who got what shots.
Alan Grossman, 64, a biology professor at the Massachusetts Institute of Technology, welcomed the authorization of the third shots for transplant patients like himself and said he is eagerly awaiting his turn.
After getting a heart transplant last fall, he received two shots of the Pfizer-BioNTech vaccine, and has been trying to get a third vaccine dose. “I can’t do it without lying, or making up a lot of stuff that I’m not willing to do,” he said.
Grossman said he thinks Massachusetts General Hospital, where he had his transplant operation, will contact patients once the CDC gives final approval. “I would get in line as quickly as possible,” he said.
ASSERTIVE MEASURES
President Joe Biden, who backed incentives like million-dollar cash lotteries if that’s what it took to get shots in arms, now appears to be testing a tougher approach as new coronavirus infections soar.
In just the past two weeks, Biden has forced millions of federal workers to attest to their vaccination status or face onerous new requirements. He’s met with business leaders at the White House to press them to do the same.
Meanwhile, the administration has taken steps toward mandating shots for people traveling into the U.S. from overseas. And the White House is weighing options to be more assertive at the state and local level, including potential support for school districts defying state rules imposed by Republican leaders preventing mask-wearing.
“To the mayors, school superintendents, educators, local leaders, who are standing up to the governors politicizing mask protection for our kids: thank you,” Biden said Thursday. “Thank God that we have heroes like you, and I stand with you all, and America should as well.”
But he has refrained from using his powers to pressure Americans to get vaccinated. He’s held off, for instance, on proposals to require vaccinations for all air travelers or, for that matter, the federal workforce. The result is a precarious balancing act as Biden works to make life more uncomfortable for the unvaccinated without spurring a backlash in a deeply polarized country that would only undermine his public health goals.
Vaccine mandates are “the right lever at the right time,” said Ben Wakana, the deputy director of strategic communications and engagement for the White House covid-19 response, noting the public’s increasing confidence in the vaccines.
Many Republicans disagree and warn of federal overreaching into decisions that should be left to individuals. Biden and Gov. Ron DeSantis of Florida, an epicenter of the latest virus wave, have spent weeks feuding over the proper role of government during a public-health crisis.
There is notable support for vaccine mandates. According to a recent poll from the Kaiser Family Foundation, 51% of Americans say the federal government should recommend that employers require their workers to get vaccinated, while 45% say it should not.
For now, Biden has required most federal workers to attest to their vaccination status under potential criminal penalties, with those who have not received a dose required to maintain social distancing, test weekly for the virus and face other potential restrictions on their work.
Health workers at the Department of Veterans Affairs and the Department of Health and Human Services will be required to get vaccinated, and the Pentagon has announced that it intends to mandate vaccinations for the military by next month.