BOSTON — In a statement, Johnson and Johnson says it is providing additional experts in manufacturing, technical operations, and quality to be on-site at the Baltimore plant where the manufacturing mistake happened.
J&J says it “identified a batch of drug substance that did not meet quality standards at the site it says was not yet authorized to manufacture drug substance for its vaccine.” That means someone used the wrong ingredients. This mistake is being blamed for ruining 15-million doses.
J&J has slowed plans to get FDA approval for the Baltimore plant to produce an additional 24 million single-shot vaccine doses through April.
The good news here, J&J says it caught the mistake before the vaccine was put into vials.
More good news, the mistake had no impact on the 20-million doses already supplied to the U.S. including the 100,000 doses Massachusetts is getting next week.
This is because that bad batch was made in the Netherlands. However, Massachusetts League of Community Health Centers CEO Michael Curry says this is still a big deal in the long run as we try and schedule more appointments.
“What you don’t want is any community relying on anyone vaccine for this exact purpose,” said Curry. “To have 15 million doses of a particular vaccine ruined, it’s going to mean that the providers that have the schedules for those appointments coming up will be told ‘Well, by the way, you’re not going to get the shipment you requested and you should cancel appointments.’ You never want to cancel an appointment”
J&J confirmed the manufacturing mistake hours after Gov. Charlie Baker announced Massachusetts will be receiving 100,000 doses of the single-shot vaccine next week. That’s more doses of J&J’s vaccine than the Commonwealth has received so far.
The state received about 41,000 extra J&J doses this week. They were used for the newly launched home delivery programs. The state is now in the process of figuring out where to prioritize this new shipment coming in next week, whether it’s home delivery, or mass vax sites, or some of the hospitals and health centers.
“It’s a big deal,” Baker said Wednesday. “We got some very good news from the federal government yesterday with respect to next week. The first really significant shipment of the one-dose J&J vaccine will be going out nationwide. The total amount to be distributed next week is 10 million doses. That’s five million doses, right, that’s a big deal. Five million doses through the retail pharmacy program and then another five million doses to states.”
Governor Baker says he’s especially thrilled to get more J&J vaccines because people can be fully vaccinated within two weeks, compared to five or six weeks with Pfizer and Moderna.
“Here in Massachusetts, that’ll be definitely north of 100,000 doses of J&J vaccine and I can’t tell you how important that is. As I said before, thank God Pfizer and Moderna were there when they were there but the difference between two doses and one dose is not just convenience, it’s also capacity. If you think about all the people who you can serve with one dose and not have to schedule a second dose and take up a second seat at some point, later on, it basically doubles the amount of capacity that is available, and in addition to that the speed with which somebody actually becomes fully vaccinated.”
Johnson & Johnson’s one-dose coronavirus vaccine was approved for emergency use by the U.S. Food and Drug Administration last month.
The news of the shipments comes as the state is approaching its date where nearly all residents will become eligible for the vaccine.
“I think for many of us this is a big sign and a big statement and we have heard many times that it’s coming, that it’s coming, and this is a big sign that things are actually starting to get here,” Baker said.
“Once you receive more J&J it allows you to free up the allocation of Moderna and Pfizer,” said Curry.
Curry says although getting extra doses is good news, it doesn’t mean we will be opening up a location for people to just walk in whenever they’re free.
“We intentionally didn’t do that here because that doesn’t contribute to equity,” said Curry. “We’re opening it up by the middle of April if you want a vaccine you should be able to schedule an appointment and I think that means we have very little time to figure out this equity dilemma before we could see this become even worse.”
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