'Game-Changing' Johnson & Johnson Single-Dose Covid-19 Vaccine Meets Requirements For Emergency Use Authorization, FDA Says
BALTIMORE (WJZ) -- Johnson and Johnson's new Baltimore-made vaccine is safe and effective at fighting COVID-19 according to a new analysis from the Food and Drug Administration, which is likely to vote Friday to allow emergency use by the public.
"It's been challenging, but it has also been exciting. Obviously, we are at the forefront in the fight against COVID-19, and we are very proud to play that role," said Sean Kirk, the executive vice president at Emergent BioSolutions where the vaccine is made in Southeast Baltimore.
If the vaccine is approved, Maryland could get 40 thousand doses by next week.
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"There's going to be a tremendous--no pun intended--shot in the arm," a hopeful Maryland Governor Larry Hogan told The Washington Post.
Earlier this month, WJZ toured the inside of the Bayview facility.
The manufacturing process is not waiting for the FDA's approval. Emergent has already been making doses for weeks.
While Johnson & Johnson is made here, the vaccine is shipped to another location where it is placed in vials then sent around the country.
"It's going to take a little bit of patience. The supply is going to ramp up over time. Enough doses are going to be available," Kirk told WJZ Investigator Mike Hellgren. "There is light at the end of the tunnel for returning to a state of normalcy."
A Johnson & Johnson representative told lawmakers this week that manufacturing is moving more slowly than expected. 12 million doses were supposed to be ready by the end of this month but that number is down to roughly 4 million.
"If an emergency use authorization is issued, we anticipate allocating 3 to 4 million doses of Johnson & Johnson vaccine next week. Johnson & Johnson has announced it aims to deliver a total of 20 million doses by the end of March. We're working with the company to accelerate the pace and time frame by which they deliver the full 100 million doses, which is required by contract by the end of June," said Jeff Zeints, the White House COVID-19 Response Coordinator who met with Governor Hogan this week. "While we await the FDA's decision, we want the American people to know that we're doing the work so that if the EUA is granted we will waste getting this life-saving vaccine into the arms of Americans."
Kirk told Hellgren the supply question "is an important one" but wanted to assure Marylanders his team is up to the task.
"There's obviously a high sense of urgency to vaccinate everyone as quickly as possible. Practically speaking, that is a challenge," he told Hellgren. "There was always going to be a supply ramp over time. It was always going to be that way. I would like everyone to appreciate and understand that we are doing the very best we can to get as much safe and effective product out of the manufacturing process as possible."
The Johnson & Johnson vaccine has some big advantages: It requires just a single dose and can be refrigerated at normal temperatures and stored for three months.
It is also 72 percent effective overall in the United States, which is less than the current two-dose Moderna and Pfizer vaccines, but it is 86 percent effective against severe forms of COVID--meaning it will keep many out of the hospital.
And it was proven effective in trials at fighting more contagious strains of the virus that are now circulating in Maryland. There are at least 60 combined cases of the South African, U.K. and Brazilian variants here. Johnson & Johnson was found to be 82 percent effective at fighting severe COVID-19 symptoms in South Africa and is 64 percent effective there overall.
Trials found the vaccine was 100 percent effective at preventing deaths. "28 days after vaccination, the vaccine provided complete protection against COVID-19 related hospital and hospitalization and death," said Johnson and Johnson's Dr. Richard Nettles.
Governor Hogan said Tuesday that Maryland is in a race to vaccinate as many people as possible before variants spread widely. Most cases involving the new strain are not linked to travel, suggesting community spread already.
The state has now fully vaccinated 6.3 percent of its population.
For the latest information on coronavirus go to the Maryland Health Department's website or call 211. You can find all of WJZ's coverage on coronavirus in Maryland here.
