Kovid Vaccine: FDA-approved Johnson & Johnson shot

WASHINGTON – The Food and Drug Administration on Saturday authorized Johnson & Johnson’s single-shot Kovid-19 vaccine for emergency use, triggering a rollout of millions of doses of a third effective vaccine that could reach Americans early next week is.

The announcement reached a critical moment due to a steep decline in coronovirus cases. Looks like a plateau has arrived And millions of Americans are on the waiting list for shots.

Johnson & Johnson has promised to deliver 100 million doses to the United States by the end of June. When combined with 600 million doses of two-shot vaccines prepared by Pfizer-BioNTech and Moderna to arrive by the end of 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 even with strong data to back it up, some may see Johnson & Johnson’s shot as an inferior option.

The new vaccine has a 72 percent efficacy rate at a clinical trial site in the US – observed by a scientist, lower than the roughly 95 percent rate found in modern and Pfizer-BioNotech vaccines tested. Across all testing sites, the Johnson & Johnson vaccine also showed 85 percent efficacy against severe forms of Kovid-19 and 100 percent efficacy against hospitalization and death.

The government’s top infectious disease specialist, Dr. Anthony S. “On the number game, not necessarily on the number, because it’s a really good vaccine, and we don’t have to put as many good vaccines as we need,” Fauci said. In an interview on Saturday. “Instead of parsing the difference of 94 and 72, accept the fact that you now have three highly effective vaccines. Period.”

If Johnson & Johnson’s vaccine were the first to be authorized in the United States instead of the third, “everyone would be handstand and back flipped and high-fives,” Dr. James T. Said McDevitt, dean of clinical affairs Byler College of Medicine.

On Sunday, a committee of vaccine experts will advise the Centers for Disease Control and Prevention See you for discussion Should some population groups be given priority for the vaccine, guidance that state health officials eagerly await in anticipation of FDA authorization.

An administration official familiar with the delivery of the vaccine said that the shipment would start from Monday and delivery could be as soon as Tuesday.

Johnson & Johnson has stated that it will ship approximately four million doses as soon as the FDA authorizes delivery and delivers 16 million or more doses by the end of March. This is far less than the 37 million doses called for in a $ 1 billion federal contract, but the contract says 30-day delayed deliveries will still be considered timely.

The federal government is paying $ 10 a dose to the firm for a total of $ 100 million dose to be ready by the end of June, much less than the dose per modern and Pfizer agreed to pay, which a German partner said Developed its own vaccine with biotech.

The Johnson & Johnson one-dose vaccine will allow states to rapidly increase the number of people who have been fully vaccinated. Unlike the other two vaccines, it can be stored at standard refrigeration temperature for at least three months.

Vaccine Coordinator of Virginia Dr. Johnson & Johnson shipment will boost vaccine allocation to the state by about one-fifth next week, said Danny Avula.

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

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

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

The Assistant Secretary of State for the Department of Health of the State of Washington, Michelle Roberts, said that it would be difficult to explain the technical aspects of Johnson & Johnson’s vaccine trials as different from other drug manufacturers. Because studies were performed at different times and with different protocols, accurate comparisons can be problematic. All three tests showed that the vaccines provided protection against Kovid-19, particularly from critical illness.

There is a great need for “scientific literacy” to understand the subtle contradictions. “There are many different factors at play. But they are not, you know, instant public messages. “

Even some physicians misinterpreted the differences between the Kovid-19 vaccines, health officials said. “They believe it is apples to apples, but it is apples to oranges, or worse, apples to tires,” said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention.

Last week, Drs. Shah said, the leader of a group of specialized health clinics in his state initially turned down Johnson & Johnson’s offer of vaccine supplements, adding that his health practitioners were concerned that it was less effective than the other two .

He said he told her: “Stop right there. We need to have a zoom conversation with your entire medical staff right now. “Instead, he carefully explained the results of Johnson & Johnson to the provider, who then spoke with his employees. Twenty minutes later, the provider sent him a message: “We are on board. Send us Jammu and Kashmir”

Some state officials have been disappointed at what they see as the lack of a coordinated plan from the Biden administration about the deployment of the new vaccine. Governors have sought guidance from the White House, but administration officials have yet to leave it to the states to decide.

Even though Johnson & Johnson received substantial federal support and agreed to build at risk, federal officials familiarized with its operation said the company took a highly conservative approach to production, on the back end of its contract Emphasis on scaling.

As a result, Johnson & Johnson hopes to distribute the bulk of its 100 million doses in late spring or early summer. The country will still need them: By the end of May, Pfizer and Modern have promised to ship enough doses to vaccinate 200 million Americans, leaving about 60 million eligible adults still open. But with the spread of more infectious forms of the virus, health officials are eager to vaccinate as many Americans as possible.

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

According to Americans Kovid-19s are becoming more open to receiving vaccines Latest survey The Kaiser Family Foundation, which has been keeping an eye on the vision since December. Sixty-five percent of adults now say they have either received a single dose or will exceed 34 percent in December.

But Rupali Limaye, who studies the vaccine hesitation at Johns Hopkins University, said she was concerned about whether health officials and community leaders would emphasize the merits of the Johnson & Johnson vaccine, including How it prevents severe Kovid-19, hospitalization and death.

“People would like to know: why is this one so low and what does it mean for us?” he said. “I believe this is going to pose more questions than confidence.”

Absent in more direction from the federal government, state health officials are consulting with each other as to where to direct the new source of supply.

The Chief Medical Officer of the Association of State and Territorial Health Officials, Drs. Marcus Plecia, who represents the state’s health agencies, predicted that “they initially ship the vaccine.”

“You don’t want to say, ‘Well, we’re going to use this vaccine for our rural population because it’s easy to ship.” He said that the second rate vaccine was being given.

Dr. of Maine Shah said the new vaccine was particularly well-suited for drive-through vaccination sites, partly because it appeared less likely to trigger the types of side effects that needed to be monitored. Health officials in other states said it also makes sense to direct doses toward transient population groups, which may be less likely to show up for other shots. Colleges can be Particularly interested.

The state epidemiologist in Arkansas’ Department of Health, Drs. Jennifer Dillaha said the easy storage conditions of the vaccine could increase the number of vaccinations in other non-judicial settings, such as senior centers or sites in untouched communities that lack pharmacies or health care providers.

To limit possible confusion, some state health officials said they initially plan to direct new vaccines to new sites, not those who are already operating other vaccines.

Dr. Shah said that some pharmacists in Maine would handle one type of Kovid-19 vaccine at a time. Although this may change, Drs. Shah said, “Everyday matters. Anything that is introduced into the workflow that slows down the pace of vaccination hurts us. “

Carl Zimmer contributed reporting.

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