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FDA Emergency Nod for J&J COVID-19 Vaccine Heats Up Competition

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Johnson & Johnson’s (JNJ - Free Report) single-dose COVID-19 vaccine candidate was granted Emergency Use Authorization (EUA) by the FDA, making it the third COVID-19 vaccine to be available in the United States.

The EUA followed a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday. Meanwhile, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has also endorsed the vaccine.

The approval was based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. The company plans to file a formal biologics license application (BLA) with the FDA later in 2021

J&J believes it can supply enough vaccines for inoculation of more than 20 million people in the United States by the end of this month. J&J has an agreement to supply 100 million doses to the United States in the first half of 2021.

Last month, J&J had filed a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency, seeking approval for the vaccine. The company has also begun rolling filings in other countries. It has also filed for Emergency Use Listing with the World Health Organization for its vaccine.

Interim efficacy and safety data from the ENSEMBLE study released last month showed that J&J’s vaccine candidate was 66% effective overall at preventing moderate-to-severe COVID-19, 28 days after vaccination. Meanwhile, the single-shot vaccine was 72% effective in the United States and 85% effective overall in preventing severe disease. Importantly, the protection against severe disease was observed across geographies and against multiple rapidly emerging infectious virus variants including the South African variant.

This year so far, J&J’s shares have risen 1.3% against a decrease of 1.4% for the industry.

 

 

J&J’s COVID-19 vaccine follows Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) whose mRNA-based vaccines were launched for emergency use last year. AstraZeneca (AZN - Free Report) /Oxford University’s COVID-19 Vaccine is approved for emergency/temporary use in several countries, including the EU and U.K. but not in the United States. Johnson & Johnson and AstraZeneca’s vaccines are adenovirus vector vaccine, while Pfizer and Moderna’s products are mRNA vaccines.

Pfizer and Moderna’s vaccines have taken the lead with the companies already delivering several million doses of their vaccines. While Pfizer expects $15 billion in sales from its COVID-19 vaccine in 2021, Moderna has set a target of $18 billion in vaccine sales this year.

However, J&J has a competitive advantage. Its vaccine is the only COVID-19 vaccine to be approved for single administration. Other approved vaccines globally, including Pfizer’s BNT162b2, Moderna’s mRNA-1273 and AstraZeneca C19VAZ are approved with two-dose dosing regimen separated by three/four weeks. A single dose will require lesser vaccine production, which is key when vaccines are in short supply. A single-dose vaccine also provides patient convenience.

Meanwhile, J&J’s vaccine can be stored at much warmer temperatures than the Pfizer/Moderna vaccine. Notably, the vaccine is expected to remain stable for at least three months at normal refrigerator temperatures of 2-8°C, which makes its storage/distribution requirements less burdensome. Pfizer and Moderna’s vaccines require ultra-cold storage requirements to properly store and distribute their vaccines.

Meanwhile, as mentioned above, J&J’s candidate was around 66% effective in preventing COVD-19. Pfizer and Moderna’s products, however, achieved much higher efficacy rates of 95% and 94.1%, respectively in their studies. AstraZeneca’s COVID-19 Vaccine was, on an average, about 70% effective in preventing COVID-19. However, an important factor to consider is that Pfizer and Moderna’s studies were done in mid of 2020, much before the COVID-19 virus variants like the U.K., South African and Brazilian variants emerged. These variants have raised concerns about the efficacy of vaccines that have been authorized for emergency use by the FDA. J&J’s vaccine studies, on the other hand, were done toward the latter half of last year when the more contagious variants were circulating. Nonetheless, direct comparison between the vaccines is difficult as the studies were differently designed and had separate goals.

Nonetheless, with the entire world to be vaccinated, there is a need for multiple vaccines and all the four companies may survive and make profits from their vaccine sales. Importantly, all the four vaccines are highly protective in preventing hospitalization and death, the worst effects of COVID-19.

J&J currently has 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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