Research & Development Moderna and Pfizer race to get FDA approval for...

Moderna and Pfizer race to get FDA approval for RSV vaccine

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Pre-Covid datasets from 2019 show that before the pandemic RSV was the second most significant cause of respiratory diseases leading to hospitalization in the U.S. and most recently, there has been a spike in young children and older people suffering from RSV in the U.S.

The disease currently has no vaccine, therefore, Moderna and Pfizer’s work in developing a treatment for the disease following the record-breaking speed in the development of the Covid vaccine has been termed the golden age of vaccines.

8 years is generally considered the standard time for producing such technology but Modena Therapeutics has claimed to cut it to 2 years with the help of its mRNA technology.

Moderna Therapeutics CEO Stéphane Bancel shared that after starting phase 1 for its RSV drug in 2021, only 24 months later they have been able to produce positive phase 3 data which has been unheard of for traditional technology, which can typically take up to 6-8 years.

Although Moderna has not yet filed for FDA approval, the company has shared recent findings from its vaccine trial of over 37,000 participants- spanning over 20 countries. With the use of the developed treatment in trials, a reduction in respiratory tract diseases was observed. 

The efficacy results of the vaccine are yet to be published in a peer review journal. Moderna has revealed that in patients suffering from 2 or more symptoms of RSV over the age of 60, the drug was able to effectively prevent disease in approximately 84% of participants. The drug had an effectiveness of around 82% in patients with 3 or more symptoms. Moderna claims that no safety concerns were identified during the trial.

On the other hand, Pfizer’s vaccine is focused on helping pregnant women transfer their antibodies to the fetus to the extent that the fetus has been protected for at least 6 months of its life. Pfizer’s efficacy results are approximately 82% for the first 90 days of a baby’s life, following these results the company was quick to send out its vaccine for the FDA’s approval which is currently in consideration.

Despite the fact that the companies are in litigation against each other due to claims brought by Moderna that allege mRNA infringement, Pfizer CEO Albert Bourla has expressed his delight over Moderna’s success.

Bourla said that you cannot make a direct comparison between the two trials and Moderna’s efficacy seems to be “at the same range as our efficacy, more or less.” Once Moderna’s data is checked out Bourla is sure that the company will proceed ahead. The fact that there is no current approved vaccine for the disease and the data presented by Pfizer is quite compelling, the company is confident it will gain approval in priority review.

Moderna and Pfizer, however, are not the only companies working on getting their RSV vaccines approved. GSK who filed for FDA approval last year for its vaccine, is expecting results this May. The company’s RSV vaccine has an overall efficacy of 82.6% and reported a 94% efficacy against severe RSV for older adults as supported by trial data shared last year. 

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