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AstraZeneca’s troubled vaccine not renewed in EU; Pfizer gets big, new deal


Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.
Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

“We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters. “We’ll see what happens,” he added, leaving open the possibility of future orders.

Beyond the spat over underwhelming deliveries, the rollout of AstraZeneca’s vaccine has been crippled by data linking the vaccine to an extremely rare, life-threatening blood clotting condition that is now called “thrombosis with thrombocytopenia syndrome,” or TTS. Officials in Europe and South Africa were also troubled by preliminary data suggesting that AstraZeneca’s vaccine may not be effective against the B.1.351 variant widely circulating in South Africa.

French President Emmanuel Macron expressed his approval of the EU’s decision to pass on AstraZeneca’s vaccine for now. Current use will “help us get out of the crisis,” he said. “But for future orders, in order to respond in particular to variants, we see that other vaccines are now more effective, so this signals a European pragmatism, which I welcome.”

Shot of success

On Saturday, EU Commission President Ursula von der Leyen announced via tweet that the commission had signed a deal for Pfizer and BioNTech to provide a guaranteed 900 million vaccine doses, with an option to provide an additional 900 million, all between 2021 and 2023. The news lands on the heels of another agreement with the EU last month, in which Pfizer and BioNTech upped their shipments to the EU by 50 million doses, bringing the bloc’s total to 250 million doses in the second quarter of this year.

Pfizer and BioNTech have had a relatively charmed vaccine rollout throughout the pandemic, avoiding much of the headline-grabbing safety, efficacy, and production pitfalls that have hampered AstraZeneca, Johnson & Johnson, and other vaccine-makers.

On Friday, Pfizer and BioNTech announced that they are now seeking a full Food and Drug Administration approval of their vaccine for use in people ages 16 and up. Currently, the FDA has granted the vaccine an emergency use authorization, which is only applicable during the health emergency and involves a lighter data-submission process than a full approval. No COVID-19 vaccines have earned a full approval from the FDA to date.

It’s also widely expected that in the next few days, the companies will earn FDA authorization to use their vaccine in adolescents ages 12 to 15—another potential first.

But the success of the Pfizer and BioNTech vaccine is not without limitations. The mRNA vaccine, similar to the successful Moderna vaccine, requires ultra-cold storage, which can be challenging in low-resource settings. And currently, low- and middle-income countries are desperate for supplies of COVID-19 vaccines, which have largely been snatched up and hoarded by rich countries.

Global need

The World Health Organization on Friday granted an emergency use listing (EUL) for China’s Sinopharm COVID-19 vaccine, which has relatively easy storage requirements and is estimated to be 79 percent effective against symptomatic disease and hospitalizations.

The granting of an EUL means that the vaccine can now be rolled out globally. It is the sixth COVID-19 vaccine that the WHO has listed and the first made in China. (The five others are vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson, plus AstraZeneca’s vaccine, which is made by two different producers.)

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” Dr. Mariângela Simão, WHO’s assistant-director general for access to health product, said in a statement. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”

However, Chinese officials and experts have tempered optimism for the EUL’s immediate impact, noting that China is struggling to produce enough doses for its own people.

“This should be the golden time for China to practice its vaccine diplomacy. The problem is, at the same time, China itself is facing a shortage,” Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations, told The New York Times. “So in terms of global access to vaccines, I don’t expect the situation to significantly improve in the coming two to three months.”





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