Canada’s 1.5 Million AstraZeneca Doses From Troubled Emergent Plant Safe and High Quality, Regulator Says

As work continues on remedying a host of concerning issues at Emergent BioSolutions’ Bayview, Md., facility, Health Canada has reported that the 1.5 million AstraZeneca (AZ) doses it received from the site were up to par for safety and quality.

The country’s health regulator, after reviewing the test results of all AZ vaccine lots imported into Canada from the plant and Emergent’s quality control steps, concluded that the 1.5 million doses it received met quality specifications and were safe for use despite the highly publicized vaccine material mix-up at the site that rendered 15 million Johnson & Johnson (J&J) shots useless.

The regulator noted that it has not allowed any J&J vaccines made at the Emergent facility to enter the country.

The incident, first reported on March 31, prompted the U.S. government to intervene, putting J&J in sole control of the facility and prohibiting production of AZ vaccines there. It also moved the FDA to conduct an eight-day inspection in April that resulted in a Form 483 detailing a lengthy list of problems at the site. The situation has also drawn the attention of Democrat lawmakers who are now investigating how Emergent obtained its federal COVID-19 contract for the troubled facility and whether it “leveraged its relationship” with a Trump administration official to obtain it (DID, April 22). The site received a Form 483 in April 2020 for similar issues, and problems were also found in previous years.

The latest 483, according to John English, a regulatory compliance expert and consultant, was posted publicly by the FDA’s Centers for Biologics Evaluation and Research (CBER) with “unusual haste.” He described the document as “rather brutal in its observations,” which included personnel-related cross-contamination issues, problems with the facility’s layout and maintenance, and a lack of employee training.

Canada is due to receive 20 million AZ doses in total through a prior agreement with the British-Swedish drugmaker that will see the supply come from the U.S. It has also secured an additional 2 million doses through a deal with Verity Pharmaceuticals and the Serum Institute of India.

Until the problems at the Emergent Bayview facility are resolved and the facility gets the FDA’s Emergency Use Authorization (EUA), the U.S. is unlikely to see large amounts of J&J’s one-shot vaccine. Production of J&J’s vaccine at the site is currently halted until the issues are taken care of (DID, April 20).

Reportedly, J&J could take up to four months to replace any doses found to be contaminated beyond the initial 15 million J&J doses that were discarded, calling into question just how much use the shot will see in the U.S. after the delays.

Read the full Form 483 here: www.fdanews.com/04-21-21-Emergent483.pdf. — James Miessler