April 1 coronavirus news

Johnson & Johnson said Thursday it still expects to meet its commitments for the promised delivery of an additional 24 million doses of its Covid-19 vaccine in April, even after a quality problem at one of the company's contract manufacturers.

The plant that had the problem, run by Baltimore-based Emergent BioSolutions, has not yet been authorized by the US Food and Drug Administration to make the vaccine and has not made any of the doses that are in the current vaccine rollout.

Emergent told CNN the problem affected a single batch of "bulk drug substance" used to make vaccine.

In an emailed statement to CNN, Emergent said its quality control systems caught the batch that "did not meet specifications and our rigorous quality standards" before it got any further. The company said it isolated the material and will now dispose of it.

It did not detail what the ingredient was or how important it was for any resulting vaccine.

Some background: The New York Times reported Wednesday that workers at Emergent accidentally mixed up some of the ingredients that would have gone into as many as 15 million potential doses of vaccine. But Emergent CEO Bob Kramer told CNBC there was not a mixup between vaccines being made at the plant.

"It wasn't the case where an ingredient from one vaccine contaminated or impacted the other," he said.

He would not confirm the estimate that the batch would have affected 15 million doses.

"Importantly, the quality control systems worked as designed to detect and isolate this single batch," Emergent's statement said. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process."

Emergent added that it is confident the company will meet the FDA's requirements for authorization to make this vaccine. Emergent is also working on Covid-19 vaccines made by other companies.

It's still unclear when Emergent may get FDA authorization. Johnson & Johnson said it is continuing to work with the FDA and Emergent toward the authorization of the facility.

Keep reading.

More than 100,000 Covid-19 vaccine appointments were made in Connecticut on Thursday — the first day of eligibility for residents ages 16 and older, Gov. Ned Lamont said at a news conference.

About 43% of residents age 16 and older have already been vaccinated, with 65% of those 45 and older. More than 1,250,457 first doses have been administered, with 733,931 residents being fully vaccinated, the governor said.

Lamont said vaccine supply would likely outstrip demand by late April, and that complications in supply from Johnson & Johnson were not expected to immediately impact vaccine roll-out.

More data: Connecticut reported at least 1,580 new Covid-19 cases and at least 14 deaths on Thursday.

Note: These numbers were released by the state’s health agency, and may not line up exactly in real-time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project. 

People who have recovered from Covid-19 get as strong an immune response from just one dose of coronavirus vaccine as the general population gets after two doses, researchers reported Thursday. 

Their study, published in the journal Nature Medicine, lends support to earlier research that indicates vaccination boosts the effect of the immune response to natural infection.

“Overall, we found that individuals previously infected with SARS-CoV-2 developed vaccine-induced antibody responses after a single dose of the BNT162b2 (Pfizer–BioNTech) mRNA vaccine that were similar to antibody responses seen after a two-dose vaccination course administered to infection-naive individuals,” Dr. Susan Cheng of Cedars-Sinai Medical Center in Los Angeles and colleagues wrote in their report, published in the journal Nature Medicine. 

Cheng said the findings support the argument that people who know they have been infected can get by with just one dose of vaccine – potentially stretching the vaccine supply so more people can be vaccinated more quickly. 

"Overall, individuals who had recovered from COVID-19 developed an antibody response after a single vaccine dose that was comparable to that seen after a two-dose vaccination course administered to individuals without prior infections," added pathologist Kimia Sobhani of Cedars-Sinai, who worked on the study also.

"It appears that a single booster dose given to previously infected individuals offers the same benefit as two doses given to people without prior infection."

The team tested more than 1,000 health care workers in the Cedars-Sinai Health System who had been vaccinated with the Pfizer/BioNTech vaccine. They measured their antibody levels before or up to three days after the first dose, seven to 21 days after the first dose, and within seven to 21 days after the second dose.

The 35 people who had recovered from coronavirus had similar immune responses after one dose as 228 people who had not and who had been given both doses of vaccine – at least for 21 days afterwards. The team did not test people for longer than three weeks.

The approach is not supported by federal health officials and other experts, who say the studies show people need two doses of vaccine for optimal protection, regardless of whether they have been infected.

 

Pfizer said Wednesday its vaccine can protect against Covid-19 for at least six months, but doctors can tell patients that protection will likely last longer, according to a family physician based in Orlando, Florida.

Burrowes noted that data is currently limited by the length of time since people were first vaccinated. It could turn out immunity could last well beyond the six-month figure that Pfizer has announced.

"My patients are asking me all the time, 'Once I get the vaccine, how long am I immune for?' And I didn't have an answer for them," Dr. Adrian Burrowes told Brooke Baldwin on CNN Newsroom.  

Researchers cannot yet say if people will need boosters of the shot, as people do every year for flu vaccine, or whether the shot will provide long-term protection, as measles vaccines do.

"It's possible, certainly, that we would have to get recurrent shots for the coronavirus, and have a booster every year like we do with the flu vaccine, but right now focusing in on what we heard today about the efficacy of the vaccine and it lasting six months is great progress," Burrowes said.

The contract manufacturer whose Baltimore facility suffered a quality control failure affecting Johnson & Johnson’s coronavirus vaccine said its quality control systems “worked as designed” and caught and isolated a single bad batch of “drug substance.”

“Importantly, the quality control systems worked as designed to detect and isolate this single batch,” Emergent BioSolutions said in a statement to CNN. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” it added.

The company did not provide details of just where in the manufacturing process the quality control broke down and did not say precisely which vaccine ingredient was affected. The Baltimore-area plant makes vaccines for Johnson & Johnson, as well as other vaccine companies.

The New York Times reported Wednesday that a mix-up at the plant affected 15 million doses of vaccine.

The plant has not yet been authorized by the US Food and Drug Administration to make the vaccine, and the affected doses had not been shipped. The FDA inspects and authorizes all vaccine manufacturing facilities that supply product to the US.

“At Emergent, safety and quality are our top priorities. Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices,” the company said in its statement to CNN. “In addition, there are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly.” 

Johnson & Johnson told CNN on Wednesday that it continues to work with the FDA and Emergent toward the authorization of the facility. Johnson & Johnson has sent additional experts in manufacturing and technical operations and quality to be on site at the facility to supervise and to support all manufacturing of their vaccine.

On Thursday Johnson & Johnson said that it does “expect to meet our commitments” with the promised delivery of an additional 24 million doses of the Covid-19 vaccine in April.

The company met its commitment to deliver 20 million doses in March. 

The Michigan Department of Health and Human Services (MDHHS) announced that it has been notified of what it says is the first case statewide of the P.1 variant which was first identified in Brazil

The case is a Bay County resident and was reported by the commercial lab Quest.

Contact tracing is currently underway.

"We are concerned about the discovery of another variant in Michigan," Elizabeth Hertel, MDHHS director, said Thursday.

"It is now even more important that Michiganders continue to do what works to slow the spread of the virus by wearing their masks properly, socially distancing, avoiding crowds, washing their hands often and making a plan to get the safe and effective COVID-19 vaccine once it is their turn. We all have a personal responsibility to slow the spread of COVID-19 and end this pandemic as quickly as possible," she continued.

Nearly 154 million doses of Covid-19 vaccine have been administered in the United States, according to data published Thursday by the US Centers for Disease Control and Prevention. 

The CDC reported that 153,631,404 total doses have been administered, about 77% of the 200,496,635 doses delivered. 

That's about 3.4 million more doses reported since yesterday, for a record-high seven-day average of about 2.9 million doses per day. The seven-day average has topped 2.5 million doses per day for more than a week.  

Thirty percent of the US population — about 99.6 million people — has received at least one dose of vaccine, and nearly 17% — about 56 million people — have been fully vaccinated. 

Note: Data published by the CDC may be delayed, and doses may not have been given on the day reported. 

Brazil’s health regulatory agency Anvisa has approved Johnson & Johnson's single-dose Covid-19 vaccine for emergency use, the agency said in a statement Wednesday.

On March 19, Brazil’s health ministry signed a contract with Johnson & Johnson for the purchase of 38 million vaccine doses to be delivered between August and November of this year. 

Brazil has now authorized the use of at least four Covid-19 vaccines, others being Pfizer-BioNTech, Oxford-AstraZeneca and CoronaVac. 

Over recent weeks, Brazil announced it has signed contracts for the acquisition of Covid-19 vaccines from Russia (Sputnik V), India (Covaxin) and the US (Moderna). However, Anvisa rejected on Wednesday India’s Covaxin due to technical information related to the “Good Manufacturing Practices of the laboratory.”

Currently, the only Covid-19 vaccines being administered in Brazil are AstraZeneca doses locally produced by the Brazilian Fiocruz Institute, and CoronaVac doses produced by the Butantan research institute in the Brazilian state of Sao Paulo.

Maryland Gov. Larry Hogan on Thursday announced that every resident who wants a Covid-19 vaccine can now pre-register for an appointment at a mass vaccination site. 

"Though we are now opening pre-registration to all Marylanders, individuals who are currently eligible under phase one and phase two, but have still not yet been vaccinated, will continue to be prioritized," said Hogan at a briefing Thursday.  

"As of this week 75% of all Marylanders over the age of 65 have been vaccinated," he said. Hogan said the remaining 25% have not been in contact with health officials or don't want the vaccine.

The governor also announced that beginning Friday the state's Eastern Shore mass vaccination site in Salisbury will open with no appointment necessary, there will be a "walk-up line for any eligible Marylander," he said. 

On Thursday, "the first federal mobile vaccination units in the nation, arrived at the Maryland Emergency Management Agency headquarters in Reisterstown," the governor said. 

"In the coming days, these 32-foot trailers will be fanning out across the state," said Hogan. 

The mobile units will "help us get more shots into arms in remote areas and zip codes that rank high on the CDC social vulnerability index," the governor said. 

Charles Gischlar, deputy director for Maryland's Department of Health, told CNN the mobile units have a soft launch tentatively set to begin on Saturday and are expected to be fully operational on Tuesday.