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AstraZeneca Coronavirus Vaccine May Get FDA's Emergency Tag

The Financial Times reported that the FDA may grant emergency use authorization (EUA) to British drugmaker, AstraZeneca’s AZN potential COVID-19 vaccine, AZD1222, which it is developing in partnership with Oxford University. The report said that the EUA will be assigned based on the results of a small UK study if the data from the same are positive.

The EUA is not a full approval and is granted when the FDA believes that the known and potential benefits of the treatment outweighs its risks.

AstraZeneca’s shares were up around 1.9% on Monday in response to the news. AstraZeneca shares have risen 13.8% so far this year against the industry’s decrease of 1.9%.

 

AstraZeneca has an agreement with Oxford University for the global development and distribution of the latter’s potential recombinant adenovirus vaccine, AZD1222, to prevent COVID-19

AZD1222 is currently being evaluated in phase II/III study in the UK, Brazil and South Africa with a late-stage study due to start in the United States with 30,000 participants in the third quarter of 2020. Data from the phase I/II study on AZD1222 announced in July, showed that the vaccine candidate generated strong antibody and T-cell responses in the majority of patients. Moreover, the company has signed supply deals with several countries under which it has committed to supply more than 2 billion doses of the vaccine, if it is successfully developed. Meanwhile, it has received more than $1 billion in funding from BARDA for the development, production and delivery of the AZD1222 vaccine. The company targets to file a regulatory application to the FDA later this year.

AstraZeneca is one of the dozen companies developing a vaccine for the deadly coronavirus disease. Of these, other than AstraZeneca/Oxford University, Moderna MRNA, Pfizer PFE and its Germany-based partner, BioNTech have initiated phase III studies on a coronavirus vaccine. J&J JNJ expects to initiate a pivotal phase III study in September.

The Financial Times reports comes on the heels of FDA granting EUA to convalescent plasma, or blood from recovered COVID-19 patients, for the treatment of hospitalized COVID-19 patients. However, it is being speculated that the FDA rushed with the announcement of the EUA for plasma therapy on Sunday under pressure from Trump as the latter last week publicly expressed frustration at the slow pace of approval for coronavirus treatments/vaccines by the FDA for political reasons.

Trump’s prospects for re-election in November have been clouded by the coronavirus pandemic as he has been widely criticized for the way he handled the crisis. In such a scenario, if he can get a vaccine approved on an emergency basis before the election, it can boost his chances of re-election.

However, the FDA, in July, issued guidance documents, specifying the data that the companies need to submit in order to get approval for their COVID-19 vaccines. Though the FDA is looking to expedite the development of a vaccine, it made it clear that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approval. If it approves a vaccine for EUA and it proves unsafe or ineffective, it could dent public confidence in the agency.

AstraZeneca currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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