When Will the FDA Fully Approve Moderna's COVID-19 Vaccine?

Investors want to know when the FDA will fully approve Moderna’s COVID-19 vaccine. FDA approval could fuel sales. Here's what investors can expect.

Ruchi Gupta - Author

Sep. 29 2021, Published 8:28 a.m. ET

COVID-19 vaccine
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As the Delta variant continues to spread, there's pressure to get out more COVID-19 vaccines and bolster people’s confidence in the shots. Vaccines with the full FDA approval stamp can reach more people and win over those who have been hesitant to get vaccinated. Pfizer’s vaccine, developed in partnership with BioNTech (BNTX), has already secured full clearance. When will the FDA fully approve the Moderna (MRNA) vaccine?

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After COVID-19 struck, drug companies raced to develop vaccines to protect people from the disease. That also sparked a rush to find the best vaccine stocks to buy amid the COVID-19 pandemic. The FDA accelerated its review process to speed up the release of COVID-19 vaccines. The regulator proceeded to grant emergency use authorization to Pfizer, Moderna, and Johnson & Johnson (JNJ) vaccines. In August 2021, the FDA granted full approval to the Pfizer vaccine.

What does full FDA vaccine approval mean?

For the population, the full FDA stamp of approval can bolster the confidence in the vaccine. Out of the millions of eligible Americans who haven’t gotten vaccinated, some simply lack faith in the vaccines because they still view them as experimental work. In a survey, the Kaiser Family Foundation found that three out of 10 Americans who haven’t been vaccinated against COVID-19 were open to getting a full-approved vaccine.

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Recently, NBA superstar LeBron James confirmed that he got a COVID-19 vaccine after previously being skeptical of it. Although it isn't clear the specific vaccine the star received, the confirmation comes after Pfizer’s vaccine won full FDA approval.

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For vaccine companies, full FDA approval can fuel sales. With full approval, a company can market its vaccine directly to consumers. The company can reach more potential customers and generate more revenue. Also, full authorization allows a company to continue selling its vaccine even after the COVID-19 pandemic ends. A company might be more flexible to raise the price of its vaccine after it secures full FDA clearance.

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When will the FDA fully approve Moderna’s COVID-19 vaccine?

Moderna has applied to the FDA for full approval of its COVID-19 vaccine. It launched the application process in June 2021 and completed it in August 2021. It could take eight months before the FDA completes the review of Moderna’s application.

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The review of Pfizer’s application for full approval took a shorter period. Pfizer sought full approval of its vaccine in May 2021 and the FDA granted it in August 2021 after about three months. Therefore, the FDA could expedite the approval of Moderna’s vaccine as well.

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When will the FDA fully approve other COVID-19 vaccines?

Johnson & Johnson is also expected to follow Moderna and seek full FDA approval of its COVID-19 vaccine, which could happen before the end of 2021. Novavax (NVAX) plans to seek FDA approval of its vaccine. Unlike the Pfizer, Moderna, and Johnson & Johnson vaccines, the Novavax vaccine hasn’t been granted emergency use authorization in the U.S. Novavax could still seek full approval of the vaccine straightaway.

What is the FDA COVID-19 vaccine approval process?

Once a company completes the clinical trials of its vaccine candidate, it applies to the FDA for approval. That process involves submitting data on clinical studies and other documents the regulator might require.

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The FDA evaluates the vaccine candidate for safety and efficacy. It also inspects the facility that will produce the vaccine. Depending on the outcome of its review and the length of clinical trial data, the regulator can deny approval, grant limited approval in case of an emergency, or issue a full-blown clearance.

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Best COVID-19 vaccine stocks to buy now

If you’re seeking exposure to the COVID-19 vaccine business, some of the best vaccine stocks to consider now are:

  • Pfizer (PFE)

  • BioNTech (BNTX)

  • Moderna (MRNA)

  • Johnson & Johnson (JNJ)

  • Novavax (NVAX)

  • AstraZeneca (AZN)

Pfizer and BioNTech are behind the only fully approved COVID-19 vaccine in the U.S. currently. Moderna could win full approval of its vaccine soon, which could boost its sales. Johnson & Johnson could also expand its vaccine market with full FDA clearance.

Novavax plans to seek FDA approval of its vaccine but has sought approval in other countries. Novavax looks to distribute its vaccine through the Covax program to low-income countries. The AstraZeneca (AZN) vaccine hasn’t been approved in the U.S. but is already in the market in more than 100 countries.


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