Execs At Spoiled Vaccine Company Knew Of Quality Issues In Advance

Roll Call: Executives Defend Quality Control At Troubled COVID-19 Vaccine Plant 
Executives at a vaccine contractor responsible for contaminating millions of vaccine doses defended its manufacturing quality Wednesday, even as new revelations emerged about the company’s lapses in sanitation, the role of a top Trump administration official in its COVID-19 contracts and their own bonuses. Emergent BioSolutions, a pandemic preparedness company that received billions in federal investments over the years, was contracted by Johnson & Johnson and AstraZeneca to make the active ingredient in their vaccines. But no COVID-19 vaccine manufactured by the company has been distributed for use in the United States. (Kopp, 5/19)

Stat: Emergent Knew Of Vaccine Manufacturing Issues As It Collected Millions
Under a contract awarded by the Trump administration, Emergent BioSolutions was paid $27 million a month to make Covid-19 vaccines, but the company already knew of serious quality control problems at its Baltimore plant, but failed to take any action, according to documents released by two House committees. The manufacturing problems forced the company to destroy millions of doses of Johnson & Johnson Covid-19 vaccines earlier this year that were to have been made at the plant. In fact, a J&J audit conducted shortly after the contract was awarded found potential “weaknesses” and a “deficient” strategy for controlling contamination. (Silverman, 5/19)

The Wall Street Journal: Emergent Has Made Over 100 Million Doses Of J&J Covid-19 Vaccine, CEO Says
Emergent BioSolutions Inc. has made enough of a key ingredient to yield more than 100 million doses of Johnson & Johnson’s JNJ Covid-19 vaccine, and federal health regulators are evaluating whether to release the shots, Emergent’s chief executive said. Emergent CEO Robert Kramer apologized during a congressional hearing Wednesday for the problems at the company’s Baltimore plant that resulted in the contamination earlier this year of a batch of the vaccine. (Loftus, 5/19)

Politico: J&J Vaccine Production Could Restart In U.S. 'Within Days,' Emergent Executive Testifies
Emergent BioSolutions could resume manufacturing Johnson & Johnson's Covid-19 vaccine within days, CEO Robert Kramer told a House panel Wednesday. The Food and Drug Administration ordered Emergent to pause production last month after a series of manufacturing problems at its Baltimore plant, one of which led to the contamination of 15 million J&J doses with ingredients from a Covid-19 vaccine made by AstraZeneca. The federal government directed AstraZeneca to find a new production partner after the mix-up. (Owermohle, 5/19)

In other vaccine development news —

The Washington Post: FDA Allows Pfizer-BioNTech Vaccines To Be Stored In Ordinary Refrigerators For Up To A Month
The U.S. Food and Drug Administration has eased the cold storage rules for the Pfizer-BioNTech coronavirus vaccine so that the doses can be kept longer at normal refrigerator temperatures. The move will simplify the transport and delivery of this highly effective vaccine that has to be stored at ultra-cold temperatures in special freezer units. Previously once the vials had been thawed, they could only be stored in a normal refrigerator for five days — that time period has now been extended to a month.“ (Schemm and Ang, 5/20)

Axios: Pfizer CEO Albert Bourla: New Vaccine Is Coming That's Easier To Store 
Pfizer is working on a "new version" of its coronavirus vaccine that will be easier to store at higher temperatures, Pfizer CEO Albert Bourla told Axios during a virtual event on Wednesday. One of the hardest parts of the COVID-19 vaccine rollout was ensuring that vaccination centers, pharmacies, and doctor's offices would have the correct — and very cold — storage conditions. (Saric, 5/19)