Will the Fourth COVID-19 Vaccine in U.S. Get FDA Nod Soon?

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There are already three approved (emergency use) vaccines in the United States marketed by PfizerPFE/BioNTech, Moderna MRNA and J&J JNJ. However, it seems that the fourth vaccine from AstraZeneca plc AZN is not too far from getting emergency approval from the FDA as the latest data from the U.S study for the AstraZeneca vaccine for COVID-19 looks promising.

Late-stage data from a large-scale U.S. study on AstraZeneca and Oxford University’s COVID-19 vaccine, AZD1222 showed that the candidate was 79% effective in preventing COVID-19 infection.

The study also demonstrated 100% efficacy against severe or critical disease and hospitalization. The efficacy appeared to remain consistent across ethnicity and age. In participants aged 65 years and over, vaccine efficacy was 80%. The efficacy analysis was based on 32,449 participants. There were 141 cases of symptomatic COVID-19 among the participants. The findings reconfirm previous results observed in AZD1222 studies. We remind investors that interim data, announced in November last year from late-stage studies in the UK and Brazil on AZD1222 had shown that the vaccine was around 70% effective in preventing COVID-19 infection.

AstraZeneca’s shares rose 4% on Monday as the efficacy results from the U.S. study were better than investors’ expectations. This year so far, the company’s shares have risen 2.4% against a decrease of 1.1% for the industry.

Meanwhile, a specific review of thrombotic events as well as cerebral venous sinus thrombosis (CVST) was conducted by the independent data safety monitoring board (DSMB). The DSMB concluded that there was no increased risk of thrombosis or events characterized by thrombosis in the 21,583 participants who had received at least one dose of the vaccine.

The DSMB’s conclusion can prove to be a boost to the stock, which recently took a hit as many European countries, including Germany, France and Italy, temporarily paused vaccinations with AstraZeneca’s jab following some reports of blood clots in people who had received the shot.

The European Medicines Agency’s (“EMA”) safety committee investigated the thromboembolic/blood clot events related to AstraZeneca’s COVID-19 vaccine.

Last week, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded there was no increase in the overall risk of blood clots with the use of AstraZeneca’s vaccine. The PRAC, however, informed that there could be a causal link of the vaccine with some very rare cases of serious thromboembolic events with thrombocytopenia. The issue needs to be further analyzed.

The Medicines and Healthcare products Regulatory Agency (MHRA) also confirmed that the benefits of the vaccine in preventing COVID-19 far outweigh the risks after it reviewed the small number of blood clot events that occurred in the United Kingdom. Germany, France, Italy and some other European nations have now resumed using AstraZeneca's COVID-19 vaccine.

AstraZeneca will submit the latest data from the U.S. study to the FDA to seek Emergency Use Authorization (EUA) for its vaccine. Its vaccine is approved for temporary/conditional use in more than 50 countries including the European Union. However, it has not yet received authorization from the FDA.

Though Pfizer, Moderna and J&J have ramped up their production of COVID-19 vaccine, having one more effective and safe vaccine in the market will help speed up the vaccination drive in the United States as infection rates continue to rise. In-fact the AstraZeneca vaccine is the cheapest and most widely available vaccine. It can be transported and stored at normal refrigerator temperatures (2°-8°C) for at least six months. These normal storage needs may give the company an advantage from logistics point of view as it makes it much easier to distribute globally using the normal immunization distribution system.

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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