Changes after Pfizer and Moderna vaccines' full approval

What changes will be seen when Pfizer and Moderna’s vaccines receive full regulatory approval?

Currently, 3 COVID-19 vaccines have received EUA approval from the FDA… none received full regulatory approval

Pfizer filed for BLA of its vaccine in May, Moderna in June… The U.S. FDA plans to grant first formal approval by early next month

The approved vaccine will have an advantage protecting market entry of latecomer vaccines ... will also increase vaccination rate

Expectations are rising that COVID-19 vaccines of multinational pharmaceutical companies such as Pfizer-BioNTech and Moderna will receive full regulatory approval early next month.

 

If the vaccines are formally approved, what changes will we see in the current landscape where people worldwide are already receiving vaccinations under the EUA?

 

Pfizer and Moderna’s COVID-19 vaccines are the most widely used vaccines around the globe.

 

Both have received the Emergency Use Authorization (EMA) from the US Food and Drug Administration (FDA) in December last year.

 

Janssen’s vaccine also received the EUA approval in February this year.

 

However, no COVID-19 vaccine has been formally approved after submitting a Biologic License Application (BLA) to the FDA.

 

Among the three EUA-issued vaccines, Pfizer and Moderna have been taking steps for the full regulatory approval of their drugs since May and June, respectively.

 

EUA is granted when no preventive therapies or treatments are currently available, and a product in development is known to be effective or has potential benefits that outweigh the known and potential risks.

 

However, the EUA only remains effective during a public health emergency.

 

In other words, when the government lifts the declaration of the COVID-19 pandemic, vaccines that are not fully approved cannot be used for vaccination.

 

A company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials.

 

Unlike EUAs, the procedure requires extensive paperwork, which takes months to review.

 

Unlike EUAs that only require a minimum of two months’ worth of follow-up data, the full approval requires at least six months of follow-up data.

 

In addition, the regulatory authorities require more detailed CMC data in the manufacturing process and quality control in a BLA submission.

 

Simply put, the full approval process with a BLA requires an average of ten times more data than the EUA submission.

 

Nevertheless, perks do exist for receiving full regulatory approval.

 

If one vaccine receives full approval, it can enjoy exclusivity.

 

The EUA system is operated under the premise that there are no adequate or available vaccines, therefore, with a rollout of qualified, fully approved vaccines, the FDA will not be able to issue EUAs to latecomer vaccines.

 

The fully approved vaccines can also be considered for off-label prescriptions.

 

Physicians, under their own discretion, may choose to prescribe vaccines off-label to subjects that are not indicated under the EUA, such as adolescents under the age of 12.

 

Also, the fully approved vaccines can be used regardless of the pandemic period, and if Pfizer and Moderna have a fully approved vaccine, the companies will have an easier time receiving approval for their booster shots that are in development.

 

In particular, a full approval by the FDA may greatly influence approvals and reviews in other countries.

 

Also, from the health authorities’ perspective, a fully approved vaccine can improve a nation’s vaccination rate, as the ‘full stamp of approval’ works as grounds for persuading some portion of the public that were reluctant in receiving vaccinations due to concerns over side effects.

 

Also, vaccination cannot be mandated under EUA, but if a vaccine is fully approved, it will speed up mandating vaccines in companies, schools, and government agencies.

 

For these reasons, the US FDA is speeding up its review process to fully approve the first COVID-19 vaccine in early September.

 

The FDA is comprehensively reviewing the COVID-19 vaccines’ real-world data such as the efficacy, immune response, reduction over time, new infections in clinical trial participants, etc., as well as factory inspection data for the BLA.

 

The authorities are also reviewing the use of booster shots on whom and when the booster shots are needed, and what vaccines may be used as booster shots.

 

An official from the Korea Biotechnology Industry Organization explained, “The full approval may bring various ripple effects in terms of increasing the vaccination rate and market expansion.

 

That is why pharmaceutical companies spend the additional cost and time to seek full approval and why the Biden administration supports BLA submissions."