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Covid Vaccines: FDA Approved Johnson & Johnson Shots

Washington — Saturday’s Food and Drug Administration approves emergency use of Johnson & Johnson’s single-shot Covid-19 vaccine, hundreds of third effective vaccines that could reach Americans by early next week We have started to deploy 10,000 times.

The announcement arrived at a crucial moment as the number of cases of coronavirus plummeted. Seems to have leveled off And millions of Americans are on the waiting list for shots.

Johnson & Johnson has promised to provide the United States with 100 million doses by the end of June. Combined with 600 million doses of Pfizer-BioNTech and Moderna from a two-shot vaccine arriving by the end of July, there are enough shots to cover American adults who want it.

However, federal and state health officials are concerned that even with strong data to support it, some may consider Johnson & Johnson shots to be an inferior option.

The 72% efficacy rate of the new vaccine on US clinical trial sites, which many scientists praise, is less than the approximately 95% efficacy rate found in studies testing the Moderna and Pfizer-BioNTech vaccines. At all study sites, the Johnson & Johnson vaccine was 85% effective against severe forms of Covid-19 and 100% effective against hospitalization and death.

“Don’t necessarily get involved in number games because it’s a really good vaccine and we need as many good vaccines as possible,” said Dr. Anthony S. Forch, the government’s top infectious disease expert. I did. In an interview on Saturday. “Rather than analyzing the difference between 94 and 72, accept the fact that there are now three highly effective vaccines. Limit.”

If the Johnson & Johnson vaccine was first approved in the United States instead of the third, “everyone would do a handstand, backflip, or high five,” said James T. McDavid, director of clinical practice in the United States. The doctor said. Baylor College of Medicine.

On Sunday, a committee of vaccine experts advising the Centers for Disease Control and Prevention Meet to discuss Guidance that state health officials are eagerly awaiting FDA approval as to whether specific population groups should be prioritized for vaccines.

A government official familiar with vaccine distribution said shipments would begin on Monday and deliveries could arrive on Tuesday.

Johnson & Johnson announced that it will ship nearly 4 million times as soon as the FDA approves the distribution, and another 16 million times by the end of March. This is far less than the 37 million doses required by the $ 1 billion federal contract, but the contract states that 30-day delayed deliveries are still considered timely.

The federal government is paying the company $ 10 each time to prepare a total of 100 million doses by the end of June. This is significantly less than the amount agreed to be paid to German partners BioNTech and the vaccine developers Moderna and Pfizer.

With Johnson & Johnson’s single dose vaccine, the state can rapidly increase the number of people who are fully vaccinated. Unlike the other two vaccines, it can be stored at standard refrigeration temperatures for at least 3 months.

Virginia Vaccine Coordinator Dr. Danny Avla said the shipment of Johnson & Johnson will increase state vaccine allocations by nearly a fifth next week.

“I’m very excited about this,” he said. “100% effectiveness against death and hospitalization? That’s all you need to ask.”

He said the state is planning a mass vaccination event specifically for Johnson & Johnson vaccines. This is to quell allegations that there are fewer products targeted at a particular group.

“It’s very clear that this is Johnson & Johnson. Here’s what you need to know about this: If you want to do this, open your eyes wide,” he said. “If not, keep your position on the list.”

Michelle Roberts, Deputy Assistant Secretary of Health in Washington State, has a hard time explaining the technical aspects of how Johnson & Johnson’s vaccine trials differ from those of other pharmaceutical companies. I said I would. Accurate comparisons can be problematic, as studies were conducted at different times and with different protocols. All three trials have shown that the vaccine provides strong protection against Covid-19, especially against serious illness.

She said it takes a lot of “scientific literacy” to understand the subtle contrasts. “Various factors are involved, but they are not simple public messages.”

Health officials said that even some clinicians misunderstand the difference between the Covid-19 vaccines. “They assume it’s apple-to-apple, but it’s apple-to-orange, and worse, apple-to-tire,” said Dr. Nirav Shah, director of the Maine Centers for Disease Control and Prevention. ..

Last week, Dr. Shah first declined his offer to ship a dose of Johnson & Johnson vaccine by a group leader in his state’s specialty clinic, and his healthcare professionals were better than the other two. He said he was concerned that the effect would be low.

He said he told him. Now you need to have a Zoom conversation with all the medical staff. Instead, he carefully explained the results of Johnson & Johnson to the provider, who spoke to the staff. Twenty minutes later, the provider sent him a message similar to the following: Please send J & J. “

Some state officials are dissatisfied with the lack of coordinated plans from the Biden administration on how to introduce new vaccines and what they see. The governor sought guidance from the White House, but authorities have so far left the decision to the state.

Johnson & Johnson agreed to risky manufacturing with full federal support, but federal authorities familiar with its operation emphasized that the company would scale up the contract backend and against production. He said he was taking an overly conservative approach.

As a result, Johnson & Johnson is expected to provide most of the 100 million doses in late spring or early summer. The country still needs them: By the end of May, Pfizer and Moderna have promised to ship enough doses to vaccinate 200 million Americans, about 60 million eligible Not yet covered by adults. However, with the spread of more contagious variants of the virus, health officials are anxious to vaccinate as many Americans as possible as soon as possible.

Federal officials said Johnson & Johnson produced the first batch of about 4 million batches at its Dutch factory. The company’s new plant in Baltimore is expected to supply most of its dosage to the United States.

According to, Americans are more open to getting the Covid-19 vaccine. Latest survey From the Kaiser Family Foundation, which has been monitoring attitudes since December. Currently, 55% of adults say they have taken a single dose or as soon as possible, starting with 34% in December.

However, Ruparilimaier, who is studying vaccine repellent at Johns Hopkins University, said he was worried whether health officials and community leaders would fully emphasize the strengths of the Johnson & Johnson vaccine. death.

“People will want to know: why this is so low, and what does that mean for us?” She said. “I’m worried that it will raise more questions than I’m confident.”

With no further instructions from the federal government, state health officials are discussing where to direct new sources.

“Many states will be a little cautious” about where to first ship vaccines, said Dr. Marcus Precia, chief health officer of the State and Territory Health Officials Association, which represents state health agencies. Did.

“I don’t want to say,’OK, I’m going to use this vaccine for local people because it’s easy to ship.'” It can cause backlash from people who mistakenly suspect it for some reason. He said a second-class vaccine was offered.

Dr. Shah of Maine said the new vaccine is particularly suitable for drive-through vaccination sites. This is because it is unlikely to cause the kind of side effects that need to be monitored. Health officials in other states said it might also make sense to direct doses to temporary population groups that are unlikely to appear in the second shot.The university Especially interested..

Dr. Jennifer Dilaha, a state epidemiologist at the Arkansaw Department of Health, said that due to the simple storage conditions for vaccines, pharmacies and health care providers are in short supply, such as senior citizen centers and poorly serviced areas He said the number of vaccinations in non-medical environments could also increase.

To limit possible disruption, health officials in some states initially said they were planning to direct the new vaccine to a new location rather than where they were already receiving other vaccines. It was.

Dr. Shah said some pharmacists in Maine want to treat one Covid-19 vaccine at a time. That may change, but Dr. Shah said: Anything introduced into the workflow that slows the pace of vaccination will hurt us. “

Carl Zimmer contributed to the report.

Covid Vaccines: FDA Approved Johnson & Johnson Shots

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