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AstraZeneca's (AZN) Coronavirus Vaccine Gets EUA in Japan

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AstraZeneca PLC (AZN - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare has granted a special approval for emergency use of its COVID-19 vaccine, Vaxzevria, for active immunization of individuals aged 18 years and above in the country.

The emergency use approval was based on positive efficacy and safety data from a phase III Oxford University-led clinical study program held in the United Kingdom, Brazil and South Africa, as well as a phase I/II study in Japan.

The recommended use of the vaccine is two 0.5 mL doses administered intramuscularly, given four to 12 weeks apart. A gap of more than eight weeks is being considered preferable to maximize the vaccine's efficacy.

Notably, the first doses of the vaccine are expected to be available in the coming weeks in Japan.

Shares of AstraZeneca have rallied 14.8% so far this year compared with industry’s increase of 7.4%.

price chart for AZN


Notably, AstraZeneca’s COVID-19 vaccine is approved for emergency/condition use in more than 80 countries, but not in the United States. The company plans to submit a regulatory application seeking emergency use authorization (“EUA”) for its COVID-19 vaccine in the United States in a few weeks.

During the first quarter of 2021, AstraZeneca announced data from primary analysis of U.S. phase III study of its COVID-19 vaccine, which showed vaccine efficacy of 76% at preventing symptomatic COVID-19, consistent with previously reported interim data. Moreover, vaccine efficacy was 85% in adults 65 years and older and the vaccine was 100% effective in preventing severe or critical disease and hospitalization.

In the first quarter of 2021, AstraZeneca’s COVID-19 vaccine added $275 million to revenues from delivery of 68 million doses in several countries.

Other approved coronavirus vaccines for emergency use include Pfizer (PFE - Free Report) /BioNTech’s BNT162b, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s (JNJ - Free Report) single-shot coronavirus vaccine.

Zacks Rank

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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