Pfizer’s ( PFE Quick Quote PFE - Free Report) mRNA-based COVID-19 vaccine, Comirnaty (BNT162b), has become the first vaccine to receive full approval in the United States. It is also the first COVID-19 vaccine anywhere across the globe to gain complete approval in any country. The full approval to the vaccine is for individuals aged 16 years or older. Other available COVID-19 vaccines are currently authorized for emergency/conditional/temporary use in several countries for adults, with a few for adolescents as well.
The complete approval to Comirnaty has not only boosted the stocks of other COVID-19-vaccine makers but also fueled a small rally in the broader market.
Pfizer achieved the full approval for its COVID-19 vaccine within nine months of its first authorization for emergency use in the United States in December 2020.
Amid rising COVID-19 infections with prevalence of the Delta variant, the full approval to Comirnaty comes as a relief. The approval will allow Pfizer to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering infection cases. Per a National Geographic
article, experts believe that the full approval will likely reduce hesitancy among people regarding inoculation with the vaccine as well as provide doctors with more flexibility in terms of doses. The company’s COVID-19 vaccine booster dose was recently authorized for immunocompromised individual in the United States. Rise in infection cases in the United States even after vaccination of majority of the citizens may see authorization for a booster dose for all adolescents and adults as early as next month.
We note that Pfizer’s Comirnaty is already leading the vaccination race, having achieved $11.3 billion sales in the first half of 2021. Moreover, the anticipated sales for 2021 for Comirnaty stands at $33.5 billion. The complete approval in the United States is likely to be followed by other countries as well soon. A complete approval in multiple countries may further boost the demand for Comirnaty.
Here we present three companies whose vaccines enjoy the U.S. authorization and have gained or will likely gain with full approval for Pfizer’s vaccine approval.
BioNTech SE ( BNTX Quick Quote BNTX - Free Report)
The company has developed Comirnaty in collaboration with Pfizer. It is a direct beneficiary of the full approval. It is the only commercialized product in BioNTech’s portfolio that has significantly boosted its prospects over the course of last few quarters. In the first half of 2021, the company recorded aggregate contribution from COVID-19 vaccine of more than $9 billion. The company anticipates total COVID-19 vaccine revenues in 2021 to be more than $19 billion (nearly €15.9 billion).
Shares of the company gained 9.6% following full approval to Comirnaty from the FDA. The company’s stock is likely to gain further going forward with more regulatory approval in other countries. Moreover, the vaccine is authorized for emergency use in individuals 12-15 years and may gain full approval for this patient population soon.
The company’s earnings estimates have moved north 19.4% for 2021 and 35.2% for 2022 over the past 30 days. The stock has surged 368.7% so far this year. It carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here Moderna ( MRNA Quick Quote MRNA - Free Report)
The company is a key player in the COVID-19 vaccine space. The company also markets a mRNA-based COVID-19 vaccine, mRNA-1273, which significantly boosted its revenues in the first half of 2021. However, the vaccine has been lagging Pfizer’s vaccine in gaining regulatory approvals for expanded labels in the United States as well as in terms of total sales.
Moderna’s vaccine generated sales of nearly $6 billion in the first half of 2021. The company expects total COVID-19 vaccine revenues to be approximately $19.2 billion for the full year 2021. Moreover, the company is also seeking full approval for its COVID-19 vaccine. It has initiated
rolling submission of a biologics license application for the same in June. It has also submitted regulatory applications seeking emergency use authorization in the United States and other countries for the use of its COVID-19 vaccine, mRNA-1273, in adolescents (aged 12 to less than 18). Along with Pfizer, the company also gained authorization for a booster dose in immunocompromised individuals.
Earnings estimates were revised upward by 13.4% for 2021 and 25.8% for 2022 over the past 30 days. The company’s stock has gained 294.2% so far this year. Moderna carries a Zacks Rank #2 (Buy) currently.
Johnson & Johnson ( JNJ Quick Quote JNJ - Free Report)
The pharma bigwig’s COVID-19 jab is the only single-shot vaccine across the globe. The vaccine uses an adenovirus-based technology instead of mRNA-technology used by Pfizer and Moderna, the leaders in this race.
Although the vaccine is far behind in the COVID-19 vaccine race, the prominence of J&J may help gain market share with its presence in multiple countries. The company has faced manufacturing delays with its COVID-19 vaccine that has hampered its prospects. The company’s vaccine has generated approximately $264 million in sales since its first authorization in the United States in March 2021. The company anticipates COVID-19 vaccine to generate $2.5 billion in sales in 2021.
The company’s late authorization is adversely impacting its regulatory approvals for expanded patient population or booster dose due to unavailability of enough data. However, its authorization in different countries will boost the vaccine sales going forward.
The company’s earnings estimates were up 0.8% for 2021 over the past 30 days. The company’s stock has increased 19.3% so far this year. J&J currently carries a Zacks Rank of 3.
Novavax ( NVAX Quick Quote NVAX - Free Report) can be another potential winner in the COVID-19 vaccine race. Although the company’s COVID-19 vaccine is yet to receive an authorization/approval, the vaccine demonstrated robust efficacy in a late-stage study. In June 2021, Novavax announced data from the phase III PREVENT-19 study, which evaluated NVX-CoV2373 in the United States and Mexico. The study met its primary endpoint by demonstrating an overall vaccine efficacy of 90.4%. The vaccine also provided 100% protection against moderate and severe disease — a key secondary endpoint. The company plans to file for emergency use authorization with the FDA in the fourth quarter of 2021. The company is also developing a booster dose of its COVID-19 vaccine.