FDA clears Johnson & Johnson’s shot, the third vaccine for USA

Rethinking America
By Editor_1
An investigational pharmacy technician holds a dose of the Johnson & Johnson COVID-19 vaccine before it is administered in a clinical trial on December 15, 2020 in Aurora, Colorado, USA -Michael Ciaglo/Getty Images
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By Noah Weiland and Sharon Lafraniere

WASHINGTON — The Food and Drug Administration (FDA) on Saturday (27) authorized Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use, beginning the rollout of millions of doses of a third effective vaccine that could reach Americans by early next week.

The announcement arrived at a critical moment, as the steep decline in coronavirus cases seems to have plateaued and millions of Americans are on waiting lists for shots.

Johnson & Johnson has pledged to provide the United States with 100 million doses by the end of June. When combined with the 600 million doses from the two-shot vaccines made by Pfizer-BioNTech and Moderna slated to arrive by the end of July, there will be more than enough shots to cover any US adult who wants one.

But federal and state health officials are concerned that even with strong data to support it, some people may perceive Johnson & Johnson’s shot as an inferior option.

The new vaccine’s 72% efficacy rate in the US clinical trial site — a number scientists have celebrated — falls short of the roughly 95% rate found in studies testing the Moderna and Pfizer-BioNTech vaccines. Across all trial sites, the Johnson & Johnson vaccine also showed 85% efficacy against severe forms of COVID-19 and 100% efficacy against hospitalization and death.

“Don’t get caught up, necessarily, on the number game, because it’s a really good vaccine, and what we need is as many good vaccines as possible,” Dr. Anthony Fauci, the government’s top infectious disease expert, said in an interview Saturday. “Rather than parsing the difference between 94 and 72, accept the fact that now you have three highly effective vaccines. Period.”

If Johnson & Johnson’s vaccine had been the first to be authorized in the United States instead of the third, “everybody would be doing handstands and back flips and high-fives,” said Dr. James McDeavitt, dean of clinical affairs at Baylor College of Medicine.

On Sunday (28), a committee of vaccine experts who advise the Centres for Disease Control and Prevention were set to meet to discuss whether certain population groups should be prioritized for the vaccine, guidance that state health officials have been eagerly awaiting in anticipation of the FDA’s authorization.

An administration official familiar with the distribution of the vaccine said that shipments would begin Monday (March 1) and deliveries could arrive as soon as Tuesday (March 2).

Johnson & Johnson has said it will ship nearly four million doses as soon as the FDA authorizes distribution and another 16 million or so doses by the end of March. That is far fewer than the 37 million doses called for in its $1 billion federal contract, but the contract says that deliveries that are 30 days late will still be considered timely.

The federal government is paying the firm $10 a dose for a total of 100 million doses to 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 one-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, vaccine coordinator for Virginia, said the Johnson & Johnson shipments would boost the state’s allotment of vaccine next week by nearly one-fifth.

“I’m super-pumped about this,” he said. “A hundred percent efficacy against deaths and hospitalizations? That’s all I need to hear.”

He said the state was planning mass vaccination events specifically for the Johnson & Johnson vaccine, partly to quell any suspicion that it is a lesser product targeted to specific groups.

“It will be super clear that this is Johnson & Johnson, here’s what you need to know about it. If you want to do this, you’re coming in with eyes wide open,” he said. “If not, you will keep your place on the list.”

Michele Roberts, assistant secretary of Washington state’s health department, said that it would be difficult to explain the technical aspects of how Johnson & Johnson’s vaccine trials differed from those of other drugmakers. Because the studies were conducted at different times and with different protocols, precise comparisons can be problematic. All three trials showed the vaccines provided strong protection against COVID-19, especially for severe disease.

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

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

Some state officials have been frustrated by what they view as a lack of a coordinated plan from the Biden administration on how to deploy the new vaccine. Governors have asked the White House for guidance, but administration officials have so far left it up to the states to decide.

Even though Johnson & Johnson received ample 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 scaling up on the back end of its contract.

As a result, Johnson & Johnson is expected deliver the bulk of its 100 million doses in the late spring or early summer. The country will still need them: By the end of May, Pfizer and Moderna have promised to ship enough doses to vaccinate 200 million Americans, leaving roughly 60 million eligible adults still uncovered. But with the spread of more contagious variants of the virus, health officials are anxious to vaccinate as many Americans as fast as possible.

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

Shah of Maine said the new vaccine was particularly well-suited for drive-thru vaccination sites, partly because it appeared less likely to trigger the kinds of side effects that require monitoring. Health officials in other states said it might also make sense to direct doses toward transient population groups who might be less likely to show up for second shots. Colleges might be particularly interested.

-New York Times

 

 

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