Inspectors force AstraZeneca's Mexico vaccine partner to overhaul its factory, holding up shot production

While Mexico is receiving small shipments of AstraZeneca's COVID-19 vaccines from overseas, two large shipments of the active ingredient used to make it remain unused. The holdup? Problems at a domestic factory tasked with finishing the shots, according to Mexico’s foreign minister Marcelo Ebrard.

The delay is another blow to the U.K.-based drugmaker, which aggressively locked down worldwide supply deals early in the pandemic but is struggling to deliver what was promised. 

In Mexico, which has registered more than 2 million coronavirus cases and 175,000 deaths, according to the Johns Hopkins Coronavirus Resource Center, local manufacturer Laboratorios Liomont has had to overhaul its operations to win government certification, forcing production delays.

Ebrard said Mexico’s regulatory agency, the Federal Commission for the Protection against Sanitary Risk, made 185 “observations” during a visit to Laboratorios Liomont, which previously produced flu shots.

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“They almost had to make another factory,” said Ebrard at a government news conference on Tuesday. “You are talking about health, life … so you do have to be very strict in any medicine, with a vaccine more, and even more when the vaccine is so recent.”

The facility expects to start shipping doses of the COVID-19 vaccine by early April. AZ has delivered at least two shipments of the active ingredient, enough to finish out 7 million doses.

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Meanwhile, Mexico has received 870,000 of a 2 million-dose order from AstraZeneca’s manufacturing facility in India. Another 494,000 doses of Pfizer-BioNTech's shot are expected to arrive this week.

As part of an ambitious plan to supply 2 billion COVID-19 vaccine doses per year worldwide, AZ also made lucrative deals with Brazil, Argentina, China and Japan, as well as closer to home with the EU. It has a deal with the U.S. for up to 400 million doses, but the shot has yet to win the FDA's blessing because of conflicting data from its late-stage trials. The company is running a follow-up trial to support another run at FDA authorization.

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Reduced yields at a manufacturing site in Europe have hit the supply chain to the EU, creating friction with the 27-country trading bloc.

And with evidence that AstraZeneca’s COVID-19 vaccine is ineffective against the disease’s variant in South Africa, that country is set to return one million doses to AZ’s production facility, the Serum Institute of India.

Additionally, in another bit of difficult news for AstraZeneca, SVB Leerink analysts are now saying that inconsistent manufacturing of its vaccine for clinical trials against the South African variant may account for the inconclusive results FDA has questioned.