Covid Vaccines: Johnson & Johnson’s shot licensed by F.D.A.

WASHINGTON – The Food and Drug Administration on Saturday approved Johnson & Johnson’s one-of-a-kind emergency Covid-19 vaccine, starting millions of doses of a third effective vaccine that could hit Americans early next week.

The announcement came at a critical time as the sharp drop in coronavirus cases appears to have plateaued and millions of Americans are on waiting lists to be shot.

Johnson & Johnson has pledged to make 100 million cans available to the US by the end of June. Combined with the 600 million doses of two-shot vaccines manufactured by Pfizer-BioNTech and Moderna due to arrive in late July, there will be more than enough shots to cover any American adult who wants one.

But federal and state health officials are concerned that some people may view Johnson & Johnson’s shot as an inferior option despite poor data.

The 72 percent effectiveness of the new vaccine at the clinical trial site in the US – as a number of scientists have celebrated – is below the rate of around 95 percent found in trials testing the Moderna and Pfizer-BioNTech vaccines. Across all trial sites, the Johnson & Johnson vaccine showed 85 percent effectiveness against severe forms of Covid-19 and 100 percent effectiveness against hospitalizations and deaths.

“Don’t necessarily get involved in the numbers game because it’s a really good vaccine and we need as many good vaccines as possible,” said Dr. Anthony S. Fauci, the government’s leading infectious disease expert, in an interview on Saturday. “Instead of analyzing the difference between 94 and 72, accept the fact that you now have three highly effective vaccines. Period.”

If the Johnson & Johnson vaccine had been the first to be approved in the US instead of the third, “everyone would be doing handstands and backflips and high-fives,” said Dr. James T. McDeavitt, Dean of Clinical Affairs, 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 populations should be prioritized for the vaccine. These guidelines have been eagerly awaited by state health authorities in anticipation of FDA approval.

A administration official familiar with the distribution of the vaccine said deliveries would start Monday and deliveries could arrive as early as Tuesday.

Johnson & Johnson has announced that it will ship nearly four million cans once the FDA clears distribution and another 16 million cans by the end of March. That’s far less than the 37 million cans foreseen in his $ 1 billion federal contract, but the contract states that deliveries 30 days late are still considered to be on time.

The federal government is paying the company $ 10 per dose for a total of 100 million doses that should be ready by the end of June, significantly less per dose than agreed to pay Moderna and Pfizer, who developed their vaccine with a German partner, BioNTech .

With Johnson & Johnson’s single-dose vaccine, states can rapidly increase the number of people fully vaccinated. 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 supplies from Johnson & Johnson would add nearly a fifth to the state’s vaccine allotment next week.

“I’m super excited,” 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 suspicions that it is a lesser product targeted at 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 this, come in with your eyes open, ”he said. “If not, keep your place on the list.”

Michele Roberts, assistant secretary for the Washington State Department of Health, said it was difficult to explain the technical aspects of the differences between Johnson & Johnson’s vaccine studies and those of other drug companies. Because the studies were conducted at different times and with different protocols, accurate comparisons can be problematic. All three studies showed that the vaccines offer strong protection against Covid-19, especially in severe illness.

Updated

Apr. 27, 2021 at 10:36 AM ET

Understanding the subtle contrasts requires a lot of “scientific expertise,” she said. “There are so many different factors at play. But that’s not quick public news. “

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

Last week, said Dr. Shah, the head of a group of specialist clinics in his state initially turned down his offer to ship doses of the Johnson & Johnson vaccine, saying his doctors were concerned that this would be less effective than the other two.

He said he said to him, “Stop right there. We now need to have a Zoom talk with all of your medical staff. “Instead, he carefully explained the results from Johnson & Johnson to the vendor, who then spoke to their employees. Twenty minutes later the provider sent him a message: “We are on board. Send us the J & J. ”

Some state officials have been frustrated with what they see as the lack of a coordinated plan by the Biden government to introduce the new vaccine. The governors have sought advice from the White House, but government officials have so far left it to the states to decide.

Although Johnson & Johnson received ample federal support and agreed to manufacture at risk, federal officials familiar with the way it worked said the company had an overly conservative approach to manufacturing and emphasized scaling at the back of its contract.

As a result, Johnson & Johnson is expected to ship the majority of its 100 million cans in late spring or early summer. The country will continue to need them: by the end of May, Pfizer and Moderna have promised to ship enough doses to vaccinate 200 million Americans, so that around 60 million eligible adults are not yet covered. However, with more contagious variants of the virus spreading, health officials are keen to vaccinate as many Americans as possible as soon as possible.

Johnson & Johnson produced its first batch of approximately four million cans at its Dutch facility, federal officials said. The company’s new facility in Baltimore is expected to supply the majority of its cans for the United States.

Americans are becoming more open to Covid-19 vaccines, according to the latest survey by the Kaiser Family Foundation, which has been overseeing attitudes since December. Fifty-five percent of adults say they either received a dose or will receive it as soon as possible, up from 34 percent in December.

However, Rupali Limaye, who studies vaccine hesitation at Johns Hopkins University, said she was concerned about whether health officials and community leaders would emphasize the strengths of the Johnson & Johnson vaccine, including how well it did the occurrence of Severe Covid-19, hospitalization and hospitalization prevents death.

“People will want to know: why is this so much less and what does it mean to us?” She said. “I worry that there will be more questions than trust.”

Without further instructions from the federal government, the state health authorities consult with each other as to where the new source of supply should be directed.

Dr. Marcus Plescia, the chief medical officer of the Association of State and Territorial Health Authorities, which represents state health authorities, predicted that “many states will be a little careful” about where they originally ship the vaccine.

“They don’t mean to say, ‘OK, we’re going to use this vaccine for our rural population because it’s easier to ship.'” This can spark a backlash from people who, for some reason, mistakenly suspect a second-rate vaccine is being offered , he said.

Dr. Maine-based Shah said the new vaccine is particularly good for drive-through vaccination sites, also because it is less likely to cause the kind of side effects that need to be monitored. Health officials in other states also said it might make sense to target the doses at transient populations who are less likely to show up in second shots. Universities could be particularly interested.

Dr. Jennifer Dillaha, the state epidemiologist with the Arkansas Health Department, said the simpler storage conditions for the vaccine could also increase the number of vaccinations in other non-medical facilities such as senior centers or locations in underserved communities with no pharmacies or health care providers.

To limit possible confusion, some state health officials said they plan to initially route the new vaccine to new locations, not those who are already administering the other vaccines.

Dr. Shah said some Maine pharmacists would prefer to treat one type of Covid-19 vaccine at a time. Although that can change, said Dr. Shah: “Every day is important. Anything that is introduced into the workflow that slows the rate of vaccination hurts us. “

Carl Zimmer contributed to the reporting.

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