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US officials extend expiration dates on J&J vaccine doses

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By MATTHEW PERRONE AP Health Writer

WASHINGTON (AP) — Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by an extra six weeks.

The company said a Food and Drug Administration review concluded the shots remain safe and effective up to 4 1/2 months. The announcement comes after state officials warned that many unused doses in storage would expire before the end of the month.

Expiration dates for vaccines are determined based on data the manufacturer submits to regulators proving how long the shots stay at the right strength. FDA originally authorized J&J’s vaccine for use for up to 3 months after manufacture when stored at normal refrigeration levels. But J&J said the FDA extended the period to to 4 1/2 months, based on data from ongoing studies assessing the vaccine’s stability.

The FDA has been reviewing expiration dates on the three authorized vaccines as companies have continued to test samples of batches in the months since the shots first rolled out.

The extension will help maintain vaccine supplies even as the rate of new injections continues to slip. The country averaged about 800,000 new injections per day last week. That’s down from a high of nearly 2 million per day two months ago. Government officials have turned to a growing number of incentives to encourages shots — from paid time off to $1 million lottery prizes.

As vaccinations have slowed it’s become clear the U.S. is unlikely to meet President Joe Biden’s goal target to have 70% of American adults partially vaccinated by July 4. Roughly 64% of Americans older than 18 have had at least one dose, according to the Centers for Disease Control and Prevention.

J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration requirements. The shot was expected to play a key role in vaccination campaigns in rural areas and low-income countries with limited health care infrastructure.

But rival drugmakers Pfizer and Moderna have already supplied more than enough doses to meet U.S. demand, with more than 129 million Americans fully vaccinated with the companies’ two-dose shots. By comparison just 11 million Americans have been vaccinated with the J&J shot.

The U.S. is set to announce plans to donate 500 million Pfizer vaccine doses for global use over the next year, on top of 80 million doses already pledged by the end of the month.

Uptake of J&J’s vaccine in the U.S. has also been hurt by contamination problems at a Baltimore factory that helps manufacture the shots. The facility was shuttered after an FDA inspection uncovered multiple problems in April and none of the vaccines made there have been distributed.

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AP Health Writer Linda A. Johnson contributed to this story

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

COPYRIGHT 2021 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED.

FDA inspection found problems at factory making J&J vaccine

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By LINDA A. JOHNSON AP Medical Writer

The Baltimore factory hired to help make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material going into a batch of shots, U.S. regulators said Wednesday.

The Food and Drug Administration released a statement and a 13-page report detailing findings from its just-completed inspection of the idled Emergent BioSciences factory.

Agency inspectors said a batch of bulk drug substance for J&J’s single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.

Other problems cited in the inspection report included peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine batches and ingredients.

Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.

Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.

After quality problems surfaced late last month, J&J took control of the factory. The Biden administration now is working to move AstraZeneca vaccine manufacturing to another factory. AstraZeneca has yet to seek emergency authorization for use of its vaccine in the U.S.

The Baltimore factory halted all production late last week at the FDA’s request. The agency hasn’t given emergency approval to the factory, which is needed before any vaccine material made there can be distributed.

All the bulk vaccine substance inside Emergent’s factory, plus early batches made there and then put in vials and packaged by other J&J contractors, are being stored and will undergo additional testing by the FDA, the agency said.

“We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” the FDA said.

At the moment, use of the J&J vaccine is on hold in the U.S. as government health officials investigate its possible connection to very rare blood clots. Their decision on whether to allow its use to resume could come Friday.

On Tuesday, the European Medicines Agency’s safety committee concluded the blood clots are a very rare side effect but that the vaccine’s benefits outweigh that risk.

Emergent, a little-known drug manufacturing contractor, was granted a major role in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press.

After the J&J vaccine batch was contaminated, FDA inspectors started checking the Emergent factory on April 12 and finished their investigation on Tuesday.

The inspectors also reviewed security camera footage, which showed employees carrying unsealed bags of medical waste around in the factory, with the bags touching materials ready to be used to make vaccine batches.

The footage also showed employees moving between manufacturing areas for the two vaccines without documenting whether they changed protective gowns and showered in between, as well as removing protective clothing in the warehouse near prepared vaccine ingredients, dropping the clothing on the floor and then tossing it in open trash cans.

The report noted that Emergent didn’t sufficiently investigate the contamination of the later-discarded J&J batch and didn’t appear to have done any extra cleaning after it was discovered.

“There is no assurance that other batches have not been subject to cross-contamination,” the report stated.

It noted other problems at the factory, known as Bayview: inadequate procedures for assuring the vaccine met all quality and purity requirements, and floors and walls too damaged to be properly sanitized. The plant also was too small and not properly designed for thorough cleaning, maintenance and operations, inspectors said.

It’s unclear how long it will take the companies to resolve all the problems.

J&J has pledged to provide 100 million doses for the U.S. by the end of May and 1 billion doses globally by the end of the year.

“Right now, we can’t speculate on any potential impact this could have on the timing of our vaccine deliveries,” J&J said in a statement.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

News to Know (04/19/2021)

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BALTIMORE, Md. — Doctor Anthony Fauci is indicating the government is likely to resume use of Johnson and Johnson’s Covid-19 vaccine this week. The Center for Disease Control advisers plan to meet Friday to discuss the pause in the J & J shot after several women suffered rare blood clotting, with one dying. The CDC now says half of all American adults have received at least one Covid vaccine dose.

MINNEAPOLIS, Minn. — The prosecution and defense are set to deliver closing arguments today in the Derek Chauvin trial in Minneapolis. Then jurors will decide if Chauvin is guilty of murder for the death of George Floyd last May. During three weeks of testimony, the jury heard from 45 witnesses

NEVADA, Mo. — On Sunday a group of people in Nevada gathered at Earp park to protest recent lives lost after police encounters. The group wanted to bring attention to this issue to the local community, and says although these deaths did not occur in Missouri, they still hope to being awareness to the local community and spark conversations here.

JOPLIN, Mo. — Saturday evening Joplin for Justice hosted a rally at 7th and Rangeline to bring awareness to the death of Daunte Wright. Wright was the 20 year old man who was fatally shot by a police officer during a traffic stop in a Minneapolis suburb. Joplin for Justice says this local protest was meant to bring awareness to racial injustice in the country and show how Joplin can make changes locally.

Kansas suspends Johnson & Johnson vaccine distribution

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MISSION, Kan. (AP) – Kansas’ top health official said Tuesday that the state is suspending distribution of Johnson & Johnson’s coronavirus vaccines as federal health officials investigate reports of potentially dangerous blood clots.

(Previous Story:  US recommends ‘pause’ for J&J vaccine over clot reports)

Lee Norman, secretary of the Kansas Department of Health and Environment, predicted the pause won’t have a “big impact” on the state’s overall rate of shots. That’s because less than 4% of the shots administered in Kansas have been from Johnson & Johnson, according to KDHE data.

However, Norman noted some clinics scheduled for Tuesday morning had been put on hold, The Kansas City Star reports.

“I don’t think it’s going to be a huge setback because the last few weeks we talked about all the Johnson & Johnson vaccine we were supposed to be getting but for a variety of production and other reasons, it never materialized,” Norman said.

David Wild, vice president of performance improvement at the University of Kansas Health System, said the pause is a signal that the country’s vaccine safety mechanisms are working as designed.

“There are people up and awake 24 hours a day looking for these types of things to make sure that it is safe for the people receiving the vaccines in your community, in the country, in the world,” Wild said.

Missouri pauses J&J COVID-19 vaccine administration

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JEFFERSON CITY, Mo. (AP) – Missouri announced Tuesday that it is “pausing” administration of the single-dose Johnson & Johnson COVID-19 vaccine after federal health officials began an investigation into potentially dangerous blood clots.

Dr. Randall Williams, director of the state’s Department of Health and Senior Services, said in a news release that Missouri was taking the step out of “an abundance of caution.” The move came after the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women that occurred 6 to 13 days after vaccination

(Previous Story:  US recommends ‘pause’ for J&J vaccine over clot reports)

US recommends ‘pause’ for J&J vaccine over clot reports

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WASHINGTON (AP) – The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred 6 to 13 days after vaccination. The clots were observed in the sinuses of the brain along with reduced platelet counts – making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.”

More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.

U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow. The other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the U.S. and are not affected by the pause.

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.

They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.

Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.

Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, but that no link to its vaccine had been established.

“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines,” said Johnson & Johnson in a statement. “At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the U.S. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.

Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.

Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.

Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.

The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.

But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.

The announcement hit U.S. stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of Johnson & Johnson dropped almost 3%