WASHINGTON – The Food and Drug Administration on Saturday authorized Johnson & Johnson’s Covid-19 single-dose vaccine for emergency use, initiating the launch of millions of doses of a third effective vaccine that could reach Americans early next week.
© Dado Ruvic / Reuters
The announcement came at a critical time, as the sharp decline in coronavirus cases appears to have stabilized and millions of Americans are on vaccine waiting lists.
Johnson & Johnson has pledged to supply the United States with 100 million doses by the end of June. When combined with the 600 million doses of Pfizer-BioNTech and Moderna’s two-dose vaccines scheduled to reach the end of July, there will be more than enough doses to cover any American adult who wants one.
But federal and state health officials are concerned that even with solid data to support it, some people may perceive the Johnson & Johnson injection as an inferior option.
The 72 percent effectiveness rate of the new vaccine at the US clinical trial site – a number that scientists have celebrated – falls short of the 95 percent rate found in studies testing the Moderna and Pfizer-BioNTech vaccines. At all trial sites, the Johnson & Johnson vaccine also showed 85 percent effectiveness against severe forms of Covid-19 and 100 percent effectiveness against hospitalization and death.
© Carlos Bernate for The New York Times
Dr. Danny Avula, Virginia’s vaccine coordinator, is excited about the arrival of the newest vaccine.
“Don’t necessarily stick to the numbers game, because it is a really good vaccine, and what we need is as many good vaccines as possible,” said Dr. Anthony S. Fauci, the government’s leading infectious disease specialist. in an interview on Saturday. “Instead of looking at the difference between 94 and 72, accept the fact that you now have three highly effective vaccines. Time course.”
© Philip Cheung for The New York Times
A Covid-19 drive-through vaccination site at Dodger Stadium.
If the Johnson & Johnson vaccine had been the first to be authorized in the United States, instead of the third, “everyone would be doing handstands, jumping back and greeting,” said Dr. James T. McDeavitt, dean of clinical affairs at the Baylor College of Medicine.
On Sunday, a committee of vaccine experts advising the Centers for Disease Control and Prevention will meet to discuss whether certain population groups should be prioritized for the vaccine, guidance that state health officials eagerly awaited for FDA authorization.
A government official familiar with the distribution of the vaccine said that shipments will begin on Monday and deliveries could arrive on Tuesday.
Johnson & Johnson said it will ship nearly four million doses as soon as the FDA authorizes distribution and an additional 16 million doses by the end of March. This is far less than the 37 million doses required under his $ 1 billion federal contract, but the contract says that deliveries 30 days late will still be considered punctual.
The federal government is paying the company $ 10 per dose for a total of 100 million doses that will be ready by the end of June, substantially less per dose than it agreed to pay Moderna and Pfizer, which developed its vaccine with a German partner, BioNTech.
Johnson & Johnson’s single-dose vaccine will allow states to rapidly increase the number of people who have been fully inoculated. Unlike the other two vaccines, it can be stored at standard refrigeration temperatures for at least three months.
Dr. Danny Avula, Virginia’s vaccine coordinator, said that Johnson & Johnson’s shipments would increase the state’s vaccine distribution next week by almost a fifth.
“I’m super excited about it,” he said. “One hundred percent effectiveness against deaths and hospitalizations? That’s all I need to hear. “
He said the state is planning mass vaccination events specifically for the Johnson & Johnson vaccine, in part to suppress any suspicion that it is a minor product targeting specific groups.
“It will be very clear that this is Johnson & Johnson, here’s what you need to know about it. If you want to do that, you’re coming in with your eyes wide open, ”he said. “Otherwise, you will keep your place on the list.”
Michele Roberts, assistant secretary of the Washington State Department of Health, said it would be difficult to explain the technical aspects of how Johnson & Johnson’s vaccine tests differ from those of other drug manufacturers. Since the studies were conducted at different times and with different protocols, accurate comparisons can be problematic. All three tests showed that vaccines provide strong protection against Covid-19, especially for serious illnesses.
Understanding the subtle contrasts requires a lot of “scientific knowledge,” she said. “There are so many different factors at play. But these are not, you know, quick public messages. “
Even some doctors misinterpret the differences between Covid-19 vaccines, health officials said. “They assume they are apples with apples, but they are apples with oranges, or worse, apples with tires,” said Dr. Nirav Shah, director of Maine’s Center for Disease Control and Prevention.
Last week, said Shah, the leader of a group of health clinics in his state initially declined his offer to send doses of the Johnson & Johnson vaccine, saying his doctors feared it would be less effective than the other two.
He said he said to him, “Stop there. We need to have a conversation about Zoom right now with your entire medical team. ”Instead, he carefully explained the Johnson & Johnson results to the provider, who then spoke to his team. Twenty minutes later, the provider sent him a message saying, “We are on board. Send us J & J. ”
Some state officials were frustrated by what they see as the lack of a coordinated plan by the Biden government on how to implant the new vaccine. Governors have asked the White House for guidance, but government officials have so far left the decision of the states.
Although Johnson & Johnson received broad federal support and agreed to manufacture at risk, federal officials familiar with its operation said the company took an overly conservative approach to production, emphasizing expansion at the end of its contract.
As a result, Johnson & Johnson is expected to deliver most of its 100 million doses in late spring or early summer. The country will still need them: by the end of May, Pfizer and Moderna promised to send enough doses to vaccinate 200 million Americans, leaving about 60 million eligible adults still without coverage. But with the spread of more contagious variants of the virus, health officials are eager to vaccinate as many Americans as possible.
Johnson & Johnson produced its first batch of about four million doses at its Dutch plant, federal officials said. The company’s new plant in Baltimore is expected to deliver most of its doses to the United States.
Americans are becoming more open to receiving Covid-19 vaccines, according to the latest survey by the Kaiser Family Foundation, which has been monitoring attitudes since December. Fifty-five percent of adults now say they have received a dose or will receive it as soon as they can, up from 34% in December.
But Rupali Limaye, who studies vaccine hesitation at Johns Hopkins University, said he was concerned that health officials and community leaders would sufficiently emphasize the strengths of the Johnson & Johnson vaccine, including how well it prevents the onset of severe Covid-19, hospitalization and death.
“People are going to want to know: why is this so smaller and what does it mean for us?” she said. “I am concerned that this will cause more questions than confidence.”
In the absence of further guidance from the federal government, state health officials are consulting on where to direct the new source of supply.
Dr. Marcus Plescia, the medical director of the Association of State and Territorial Health Officers, who represents state health agencies, predicted that “many states will be a little cautious” about where they will initially send the vaccine.
“You don’t want to say, ‘OK, let’s use this vaccine for our rural populations because it is easier to transport.'” This can trigger a reaction from people who mistakenly suspect that, for some reason or another, they are being offered a vaccine. second-rate, he said.
Dr. Shah, from Maine, said the new vaccine is particularly suitable for drive-through vaccination sites, in part because it seems less likely to trigger the types of side effects that require monitoring. Health officials in other states said it may also make sense to target doses to transient population groups, who may be less likely to show up for the second injection. Colleges may be particularly interested.
Dr. Jennifer Dillaha, a state epidemiologist in the Arkansas department of health, said that easier vaccine storage conditions could also increase the number of vaccinations in other non-medical settings, such as elderly centers or locations in underserved communities that do not have pharmacies or health care providers.
To limit the possible confusion, some state health officials said they initially plan to target the new vaccine to new locations, not those already administering the other vaccines.
Dr. Shah said that some pharmacists in Maine prefer to deal with one type of vaccine Covid-19 at a time. While that may change, Dr. Shah said, “Every day is important. Everything that gets introduced into the workflow that slows down the rate of vaccination harms us. “
Carl Zimmer contributed reporting.
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