The Johnson & Johnson shot cleared by the FDA

© Dado Ruvic / Reuters

WASHINGTON – The Food and Drug Administration on Saturday cleared Johnson & Johnson’s single-injection Covid-19 vaccine for emergency use, beginning the rollout of millions of doses of an effective third vaccine that could reach Americans early in next week.

The announcement came at a critical time, as the steep drop in coronavirus cases appears to have stabilized and millions of Americans are on waiting lists for vaccines.

Johnson & Johnson has pledged to deliver 100 million doses to the United States by the end of June. When combined with the 600 million doses of the two-dose vaccines manufactured by Pfizer-BioNTech and Moderna, which are expected to arrive by the end of July, there will be more than enough vaccines to cover any American adult who wants them. .

But federal and state health officials fear that even with solid data to back it up, some people may perceive the Johnson & Johnson shot as an inferior option.

The 72% efficacy rate of the new vaccine at the US clinical trial site – a number of scientists have celebrated it – is lower than the approximately 95% rate found in studies testing the Moderna and Pfizer vaccines – BioNTech. At all trial sites, the Johnson & Johnson vaccine also showed 85% effectiveness against severe forms of Covid-19 and 100% against hospitalization and death.

© Carlos Bernate for the New York Times
Dr Danny Avula, Vaccine Coordinator in Virginia, is delighted with the arrival of the new vaccine.

“Don’t necessarily get caught up in the numbers game because this is a very good vaccine, and what we need are as many good vaccines as possible,” said Dr Anthony S. Fauci , the government’s leading infectious disease specialist. in an interview on Saturday. “Rather than analyze the difference between 94 and 72, accept the fact that you now have three very effective vaccines. Period.”

© Philip Cheung for The New York Times
A Covid-19 vaccination site at Dodger Stadium.

If Johnson & Johnson’s vaccine had been the first to be cleared in the United States instead of the third, “everyone would be doing handstands and back flips and high-fives,” said Dr. James T. McDeavitt, Dean of Clinical Affairs at Baylor College of Medicine.

On Sunday, a committee of vaccine experts who advise the Centers for Disease Control and Prevention will meet to discuss whether to prioritize certain population groups for the vaccine, a focus that health officials have said. State eagerly awaited clearance from the FDA.

An administration official familiar with the distribution of the vaccine said shipments would begin on Monday and deliveries could arrive as early as Tuesday.

Johnson & Johnson has said it will ship nearly four million doses as soon as the FDA clears distribution and an additional 16 million doses by the end of March. That’s far less than the 37 million doses requested in its $ 1 billion federal contract, but the contract says deliveries 30 days late will still be considered timely.

The federal government is paying the company $ 10 per dose for a total of 100 million doses to be ready by the end of June, significantly less per dose than it has 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, the vaccine coordinator for Virginia, said shipments from Johnson & Johnson will increase the state’s vaccine allocation by nearly one-fifth next week.

“I’m super excited about this,” 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 quell any suspicion that it is a lesser product aimed at specific groups.

“It will be very clear that this is Johnson & Johnson, here is what you need to know about it. If you want to do that, you come in with your eyes wide open, ”he says. “Otherwise, you’ll keep your spot on the list.”

Michele Roberts, assistant secretary of the Washington state health department, said it would be difficult to explain the technicalities of the difference between Johnson & Johnson’s vaccine trials and those of other drug makers. Because the studies were conducted at different times and with different protocols, precise comparisons can be problematic. All three trials showed that the vaccines offered strong protection against Covid-19, especially for serious illnesses.

Understanding the subtle contrasts requires a lot of “science literacy,” she said. “There are so many different factors at play. But these aren’t, you know, quick public messages.

Even some clinicians misinterpret the differences between Covid-19 vaccines, health officials said. “They assume it’s apples to apples, but apples to oranges, or worse, apples to tires,” said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention.

Last week, Dr Shah said, the head of a group of specialist health clinics in his state initially refused his offer to ship doses of the Johnson & Johnson vaccine, saying his health practitioners feared that it is less efficient than the other two.

He said he told her, “Stop there. We need to have a Zoom conversation now with all of your medical staff. Instead, he carefully explained Johnson & Johnson’s results to the supplier, who then spoke to his staff. Twenty minutes later, the supplier sent him a message saying, “We are on board. Send us the J & J. »

Some state officials have been frustrated by what they see as a lack of a coordinated plan from the Biden administration on how to roll out the new vaccine. Governors have sought advice from the White House, but administration officials have so far left it up to states to decide.

Even though Johnson & Johnson received broad federal support and agreed to manufacture at risk, federal officials familiar with its operation said the company had taken an overly conservative approach to production, emphasizing the scale of the end of his contract.

As a result, Johnson & Johnson are expected to deliver the bulk of its 100 million doses in late spring or early summer. The country will need it again: At the end of May, Pfizer and Moderna pledged to ship enough doses to immunize 200 million Americans, leaving an estimated 60 million eligible adults still uncovered. But with more contagious variants of the virus spreading, health officials are eager to vaccinate as many Americans as quickly as possible.

Johnson & Johnson has produced its first batch of around four million doses at its Dutch factory, federal officials said. The company’s new plant in Baltimore is expected to supply most of its doses to the United States.

Americans are increasingly open to Covid-19 vaccines, according to the latest survey from the Kaiser Family Foundation, which has been monitoring attitudes since December. Fifty-five percent of adults now say they’ve received a dose or will get it as soon as they can, up from 34 percent in December.

But Rupali Limaye, who studies vaccine reluctance at Johns Hopkins University, said she was worried about whether health officials and community leaders would put enough emphasis on the strengths of the Johnson vaccine. & Johnson, including how well it prevents the onset of severe Covid-19, hospitalization and death.

“People will want to know: why is this one so less important and what does it mean to us?” she said. “I’m afraid this will cause more questions than trust.”

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 chief medical officer of the Association of State and Territory Health Officials, which represents state health agencies, predicted that “many states are going to be a little cautious” about the where they initially ship the vaccine.

“You don’t mean, ‘OK, we’re going to use this vaccine for our rural people because it’s easier to ship.’” This can trigger backlash from people who mistakenly suspect that they are being offered a vaccine. second-rate, he said.

Dr Shah of Maine said the new vaccine was particularly well suited to drive-thru vaccination sites, in part because it seemed less likely to trigger the types of side effects that require monitoring. Health officials in other states have said it might also be a good idea to direct doses to transient population groups who may be less likely to show up for the second injection. Colleges could be particularly interested.

Dr Jennifer Dillaha, the state epidemiologist with the Arkansas Department of Health, said the easier storage conditions for the vaccine could also increase the number of vaccinations in other non-medical settings, such as clinics. or sites for the elderly in underserved communities that lack pharmacies or health care providers.

In order to limit possible confusion, some state health officials have said they initially plan to direct the new vaccine to new sites, not those that already administer the other vaccines.

Dr Shah said some pharmacists in Maine prefer to handle one type of Covid-19 vaccine at a time. While that may change, Dr Shah said, “Every day matters. Anything that gets fed into the workflow that slows down the pace of vaccination hurts us. “

Carl Zimmer contributed reporting.