One-dose vaccine may be days away

J&J candidate expected to get FDA authorizat­ion

- Karen Weintraub

A government advisory committee is likely to give a thumbs up Friday to a third COVID-19 vaccine, paving the way to increased supply of the muchin-demand vaccines.

The new vaccine, from drugmaker Johnson & Johnson, offers a few advantages over the two that have been administer­ed to 45 million Americans since mid-December, although it may be somewhat less effective. The J&J vaccine requires only one shot; the others, from Pfizer-BioNTech and Moderna, need two. It can be kept refrigerat­ed rather than frozen for longer, making it easier to distribute through doctors’ offices and rural outposts. And it may cause fewer side effects.

The advisory panel, called the Vaccines and Related Biological Products Advisory Committee, is likely to recommend the shot for use in adults. An emergency use authorizat­ion from the acting commission­er of the Food and Drug Administra­tion is anticipate­d to follow within days.

Most people will not have a say in which vaccine they get. Allocation is decided by individual states, which have generally provided only one type of vaccine at a time to each vaccinatio­n center. Public health officials say it doesn’t matter which vaccine someone receives.

A third vaccine is “nothing but good news,” Anthony Fauci, America’s top infectious disease doctor, told NBC’s “Today” show Thursday. “To have two is fine. To have three is absolutely better.”

Johnson & Johnson said it will make 20 million doses of the vaccine available in March and an additional 80 million by the end of June to fulfill a contractua­l agreement with the government. Taxpayers paid nearly $500 million to help develop the vaccine and $1 billion to produce and deliver these 100 million doses.

The government prepaid for the vaccines, and insurance companies or the government are likely to pick up the cost of administer­ing shots, so no one should have to pay out of pocket for protection.

As new variants circulate that might make vaccines less effective, it’s important to get as many people vaccinated as quickly as possible, Fauci said, to reduce transmissi­on.

Vaccines from Moderna and PfizerBioN­Tech were shown in large clinical trials last fall to be more than 94% effective, a result confirmed by a real-world study in Israel.

The J&J vaccine was found in its large trial to be 72% effective in the USA but less effective in South Africa and Latin America, where variants circulated.

Some people will be more comfortabl­e with the J&J vaccine because it is based on a technology with a longer track record or requires only one shot; others will balk at a vaccine that may be less effective.

All the COVID-19 vaccines have been shown to prevent serious disease and death.

“People should get vaccinated with whatever vaccine they can get of the ones that FDA authorizes,” said Dr. Jesse Goodman, professor of medicine and infectious diseases at Georgetown University Medical Center.

The J&J vaccine is more effective than the annual flu shot and will help rein in the pandemic, said Dr. Eric Schneider, senior vice president for policy and research at the Commonweal­th Fund, a private philanthro­py that studies health care policy and practice.

“Anything that slows transmissi­on for even a portion of the population is going to be a great addition,” Schneider said.

The less restrictiv­e storage requiremen­ts will enable the J&J vaccine to be distribute­d by primary care doctors’ offices, he said, although it’s not clear whether these offices can handle vaccinatio­ns after the disastrous year they had financiall­y in 2020, when patients stayed away and billings dropped.

“If we didn’t already have Moderna and Pfizer with 95% efficacy, we’d be jumping up and down with about J&J,” said Dr. Thomas Balcezak, chief clinical officer for Yale New Haven Health. “Somehow now that we’ve got a 95% effective vaccine … we seem to be cooling on this vaccine that a year ago we would have been thrilled to have.”

J&J uses different technology

All the vaccines are equally effective where it counts, said Anna Legreid Dopp, senior director of clinical guidelines and quality improvemen­t at the American Society of Health-System Pharmacist­s.

“They’re reducing symptomati­c severe disease that leads to hospitaliz­ation and death,” she said. “It’s those two things that will reduce the societal burden overall and the strain on our health care system on a whole.”

She said pharmacist­s will be ready to handle any vaccine, but J&J’s is based on a technology that pharmacist­s have used, so they’re likely to be more familiar with it than they were with the Pfizer-BioNTech and Moderna vaccines.

The first two vaccines are based on mRNA technology, and are virtually indistingu­ishable, with similar safety and effectiven­ess profiles. They use the body’s natural protein manufactur­ing system to deliver instructio­ns to cells to make the spike protein on the outside of the SARS-CoV-2 virus particles. Once the immune system is taught to recognize this spike protein, it will attack upon infection with SARS-CoV-2.

The J&J vaccine instead uses a harmless virus called adenovirus 26 to deliver the spike protein to cells, training the immune system.

No one in the trial suffered a severe enough allergic reaction to require epinephrin­e, though one man did endure extended hives and discomfort.

Although all the vaccines appear to be very safe, side effects seemed to be milder and less widespread with the J&J vaccine than with the other two, Dr. Colleen Kraft, associate chief medical officer for Emory University Hospital, said Thursday.

The Pfizer-BioNTech and Moderna vaccines have triggered serious allergic reactions in two to six vaccine recipients per million doses delivered. Those reactions turned up once the vaccines were given to millions of people, not during their large clinical trials.

All the vaccines can cause sore arms, muscle aches, headaches, fever, chills and other symptoms that usually pass within a day or two.

The COVID-19 vaccines are not made with eggs, unlike many flu vaccines, so they are considered safe for people with egg allergies, though other ingredient­s may trigger allergic responses.

Will vaccine distributi­on change?

Because it doesn’t need to be stored at freezer temperatur­e, it may make sense to send the J&J vaccine to rural communitie­s and small practices that may not have pharmaceut­ical-grade freezers, said Julie Morita, executive vice president of the Robert Wood Johnson Foundation.

An advisory committee to the Centers for Disease Control and Prevention, scheduled to meet Sunday and Monday, may take up the idea of targeting distributi­on to particular population­s, she noted.

Morita said she hopes increasing the overall supply of the vaccine will enable a more equitable distributi­on of shots.

Balcezak said he sees a third vaccine as “one more variable that’s going to create one more potential for inequity.”

In some ways, he said, it makes sense to allocate the J&J vaccine to inner city neighborho­ods, where it’s difficult to deliver one shot, no less two.

“The challenge with that is that’s going to inherently bias them to getting this less efficaciou­s vaccine,” he said. The country needs to “figure out how we don’t allow this to become yet another way health disparitie­s impact our Black and brown communitie­s or our inner cities.”

Goodman, co-chair of the COVID-19 Vaccine Analysis Team, a group of experts, said there’s not a lot of informatio­n about how the J&J vaccine will perform in older people. Some have suggested that it might make sense to target the J&J vaccine to younger people, who are less likely to suffer severe disease or die from COVID-19.

He would like to see major national studies of how authorized vaccines perform in the real world to better understand whether some vaccines are better suited to certain population­s.

“That’s how we’re going to uncover if these difference­s are real,” he said.

 ?? AP ?? Johnson & Johnson’s vaccine doesn’t need freezer storage like others.
AP Johnson & Johnson’s vaccine doesn’t need freezer storage like others.
 ?? DAMIAN DOVARGANES/AP ?? About 45 million have gotten a shot since December.
DAMIAN DOVARGANES/AP About 45 million have gotten a shot since December.

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