moderna covid 19 vaccine production capacity

'This is like, you know, within a week, you can try and get this thing wrapped up properly.' 'These are easy to fix,' says Thakur, who raised the alarm about quality-control problems at generics drugmaker Ranbaxy, resulting in a 2013 guilty plea and a $500 million settlement. The fact that Catalent didn't appear to have fixed its microbial contamination procedures a year earlier is what bothers him. It's a simple lapse in training, says Dinesh Thakur, a former drug company executive turned whistleblower. For example, employees weren't making sure sterile forceps didn't touch non-sterile surfaces, and they didn't follow rules around sanitizing gloved hands in certain situations involving vials and syringes.īy itself, the finding is fixable. Inspectors again found that the employees weren't following rules to prevent microbial contamination. In September, the Indiana facility received another visit from the FDA. But the company announced that it would be helping Moderna make its vaccine in June of this year. However, the findings didn't result in more serious punitive steps by the FDA, which can include formal warning letters and, in rare cases, injunctions and product seizures.Īt the time, of course, the Catalent facility wasn't working on coronavirus vaccines. public that the product is what it says it is. 'So the safety identity, the strength, the quality or the purity of the product that is being manufactured may not meet the specifications or the attestation the company is making to the U.S. 'There were production and process control failures that make it possible that the product itself is not what it purports to be,' Conti says. That could mean problems for the quality of the plant's products, Conti says. Inspectors also wrote that the facility had problems storing pharmaceuticals at the right temperature and humidity levels. Still, FDA inspectors visited Catalent's Bloomington facility in October 2019, and found that it had problems with making sure sterile products weren't contaminated with bacterial or fungal particles. population for a very long time and have a proven safety record and quality record.' They've been making vaccines for the U.S. 'There are no fly-by-night new manufacturing facilities that are being set up to make these products by definition, because there are only so many manufacturers who could make these products to begin with,' says Rena Conti, a health economics professor at Boston University whose research includes the pharmaceutical supply chain. It's a big job, but Catalent and the other contract manufacturers have long histories of doing it. Vice President Mike Pence speaks during a roundtable discussion at Catalent Biologics in Bloomington, Ind., on Tuesday.Ĭatalent is processing 500,000 doses per day, but the factory is hoping to ramp up to a million doses a day to fulfill its contractual obligations and deliver 100 million doses by the end of March, Denis Johnson, Catalent Bloomington's general manager, told the vice president.

The company's facility in Pence's home state is working with Moderna on filling vials with the vaccine and preparing them for distribution. It has dozens of factories around the world and makes more than 70 billion doses of all kinds of drugs each year. Catalent is probably the biggest drugmaker you've never heard of.

Vice President Mike Pence traveled to Bloomington, Ind., on Tuesday to tour Catalent, a contract manufacturing facility expected to help produce millions of Moderna coronavirus vaccines in the coming weeks and months. Still, the use of multiple companies to help make and package the vaccine stretches the supply and production chain and could add some risk to fulfillment of orders. Moderna is ultimately responsible for making sure the vaccine is made in compliance with regulations, and the FDA periodically inspects facilities around the world to make sure they are up to snuff. So how will Moderna make the 200 million doses it has contracted to provide the federal government for $3.2 billion by the end of June? A big part of the answer is outsourcing production to contract manufacturers that will make the vaccine on Moderna's behalf. Shots - Health News Why I'm A Vaccine Volunteer: Doing What Needs To Be Done

Moderna covid 19 vaccine production capacity