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

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 reached Americans early next week. Can.

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 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-Bioentech 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. Fauci said, “On the number game, not necessarily on the number, because it’s a really good vaccine, and we don’t need to put as many good vaccines as we need.” In an interview on Saturday. “Instead of parsing the difference between 94 and 72, accept the fact that you now 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, “everyone would have been handstand and back flipped and high-fives,” Dr. James T. Said McDevitt, dean of clinical affairs Byler College of Medicine.

A committee of vaccine experts on Sunday to advise the Centers for Disease Control and Prevention See you for discussion Should certain population groups be given priority for vaccines, guidance that state health officials eagerly await in anticipation of FDA authorization.

An administration official familiar with the delivery of the vaccine said that shipments would start from Monday and delivery could happen by Tuesday at the earliest.

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

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

Johnson & Johnson’s one-dose vaccine will allow states to rapidly increase the number of people who are 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. Danny Avula said Johnson & Johnson shipment would boost vaccine allocation to the state by about one-fifth next week.

“I’m super-pumped about this,” he said. “Hundred percent efficacy against death and hospitalization? 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 super clear that this is Johnson & Johnson, here is all you need to know about it.” If you want to do that, then you are opening your eyes, ”he said. “If not, you will keep your place in the list.”

Assistant Secretary of State for Health Department of Washington State, Michelle Roberts, said that it would be difficult to explain the technical aspects of Johnson & Johnson’s vaccine trials being different from other drug manufacturers. Because the 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 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 had initially turned down Johnson & Johnson’s vaccine supplements offer, adding that his health practitioners were concerned that it was less effective than the other two Was.

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 provider’s results to Johnson & Johnson, who then spoke with their employees. Twenty minutes later, the provider sent him a message: “We’re on board. Send us Jammu and Kashmir ”

Some state officials have become frustrated with what they see as the lack of a coordinated plan from the Biden administration about the deployment of the new vaccine. Governors have asked the White House for guidance, 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 operations said the company took a highly conservative approach to production, with 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 prepared 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 American Kovid-19 vaccines are becoming more open to receiving Latest survey The Kaiser Family Foundation, which has been monitoring the approach 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 about where to direct the new source of supply.

The Chief Medical Officer for the Association of State and Territorial Health Officers, Drs. Marcus Plecia, who represents the state’s health agencies, predicted that “many states are a little cautious” where 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.” “This may lead to a retreat for people who are wrongly suspected for some reason or another. They said that a 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. While this may change, Drs. Shah said, “Everyday matters. Anything that is introduced into the workflow that slows the pace of vaccination hurts us. “

Carl Zimmer contributed reporting.

Source link

Leave a Comment