AstraZeneca’s COVID-19 Vaccine Gains Emergency Use in 6 Countries

AstraZeneca recently announced that its COVID-19 vaccine has been granted emergency use authorization in India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco.

The authorization of COVID-19 Vaccine AstraZeneca is intended for adults 18 years of age and older for preventing the novel coronavirus. 

The approval in India is important not only to enable supply to India, but also to a large number of countries globally.

“These emergency use authorisations will soon bring the vaccine to many millions of people and are proof of our long-held commitment to broad and equitable access around the world. We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus,” Pascal Soriot, chief executive officer at AstraZeneca, said in the announcement. 

AstraZeneca partnered with Serum Institute of India (SII), the world’s largest vaccine manufacturer, to supply the vaccine to the Indian Government as well as various low and middle-income countries. 

"The emergency licensure in India marks an important milestone for all of us. The regulatory decisions are welcoming and encouraging towards ensuring equitable access to a safe, immunogenic, and affordable vaccine for millions of people worldwide,” said Adar Poonawalla, chief executive officer at SII. 

“The pandemic of 2020, however devastating - brought public and private institutions, health authorities, governments of various countries, and most importantly the global communities together to pose a resilient front against the virus.” 

Earlier this week, the United Kingdom (UK) was the first country to approve COVID-19 Vaccine AstraZeneca for emergency use to prepare for vaccinations early this year.

The authorization was based on trial results which showed that a two-dose regimen of COVID-19 Vaccine AstraZeneca was safe and effective in preventing symptomatic coronavirus in UK and Brazil trials.

Specifically, one dosing regimen showed a 90 percent efficacy when the vaccine was given as a half dose, followed by a full dose at least one month apart, while the second dosing regimen showed 62 percent efficacy when given as two full doses at least one month apart.

There were no severe cases and no hospitalizations reported more than 14 days after the second dose. 

AstraZeneca previously submitted a data package to support conditional marketing authorization for its COVID-19 vaccine to the European Medicines Agency (EMA) as part of an ongoing rolling review process and will continue to work with EMA to seek approval in the near future.

Additionally, the company will work with regulatory authorities globally to gain emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.

In addition to the University of Oxford-led trials, AstraZeneca is conducting a large trial in the US as part of a global program. In total, the trials will enroll over 60,000 participants worldwide, with additional safety and efficacy data expected to arise from ongoing trials as well. 

In total, AstraZeneca expects to manufacture and deliver up to 3 billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. 

Although COVID-19 Vaccine AstraZeneca has yet to be approved by the FDA for emergency use in the US, it is important to note that the vaccine can be stored, transported, and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings. 

In contrast, Pfizer’s mRNA COVID-19 vaccine, which has been approved for emergency use, must be stored at -112 degrees Fahrenheit to remain effective and can only be stored in the refrigerator for five days. 

This temperature requires special freezers usually found in research labs and hospitals. 

Moderna’s vaccine, which was also approved by the FDA for emergency use, has similar requirements.