VaccineImage by: NBC Los Angeles

FDA Approves Moderna’s Second-Ever Product: RSV Vaccine for Seniors

Moderna has successfully received FDA approval for a new RSV vaccine for use with adults above 60 years, making it the second product from the drug-maker to be accredited for sale in the USA. This approval is important for Moderna since it markets only one other product that is Covid-19 vaccine, hence diversifying its revenue streams is crucial.

The decision is taken after a late-phase trial of the vaccine conducted on seniors, who are prone to developing severe RSV infections. Influenza and RSV are killed by an estimated 6,000 to 10,000 seniors each year, and hospitalize between 60,000 and 160,000 seniors. The announcement marks the route for an mRNA vaccine against a disease besides COVID and the only RSV vaccine offered in a pre-filled syringe, to be convenient for those administering it and the patient.

mRESVIA’s clinical efficacy will begin to be evaluated from the third week of June, after which a CDC advisory panel will be asked to vote on its use and its target population. Moderna is expecting it to get approvals for RSV that are akin to the existing approvals on RSV vaccines from GSK and Pfizer or the ones it got for its vaccine and booster, both of which were launched in the U. S. during the fall season of the previous year and have made hundreds of millions of dollars in sales. This forecast contains Moderna’s regular and vaccine sales besides the sales from the respiratory syncytial virus (RSV) vaccine envisaged for 2024 of $4bn.

This approval occurs at a time when Moderna is demonstrating the versatility of its mRNA technology besides the Covid-19 vaccine. On this platform it is endeavoring on establishing treatment to different diseases such as cancer diseases or norovirus diseases. In the case of mRESVIA approval, the company’s chief executive, Stéphane Bancel insisted on the fact that it affirms the efforts of Moderna towards addressing challenges towards global health.

However, a universal booster shot that targets multiple strains is still a thing of the future Moderna has over 40 products in its pipeline at the moment, some of them are at the final stage of testing, including the Covid-19 and flu vaccine that can be released for use by 2025. Other projects on the pipeline are; Flu shot, Personalized cancer vaccine with Merck and Virus vaccines latent.

Moderna expects to achieve sales growth in 2025 and achieve break-even in the same year alongside new automated products. With Moderna’s mRNA platform, investors magnify their level of confidence having marked their investment over 40% this year after shrinking by 45% in 2023.

Vaccine trial data

The FDA ‘s approval of Moderna’s RSV vaccine that was supposed to be announced on May 12, 2023 was shifted due to internal ‘administrative issues. ’

A phase three trial with approximately 37,000 participants investigated and upheld that Moderna’s inoculation was 83. 7% efficacy in reducing at least two aspects of RSV after about three months. However, the recent data from February showed that the vaccine had a 63% efficacy rate after 8. 6 months. This mean reduction in efficacy brought worried among investors given the possibility that it will decline more than vaccines from GSK and Pfizer.

Moderna wrote that it cannot make direct comparisons between vaccines as these trials are not designed to compare the efficacy of vaccines directly against one another and different populations, geographic areas, as well as different RSV definitions have been used.

This trial also demonstrated that the drug was relatively safe with only a few side effects reported, those being of mild to moderate intensity, conditions like injection site discomfort, fatigue, headache, muscle and joint ache.

 

People also ask;

Is there an RSV vaccine?

There are two RSV vaccines approved for adults ages 60 years and older: GSK Arexvy pipeline and Pfizer Abrysvo pipeline. Both vaccines work as protein vaccines whereby the human body is presented with the RSV antigen and develops antibodies against it.

 

Is the RSV vaccine approved by the FDA?

(NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

 

Is RSV recommended for seniors?

RSV immunizations are recommended only for these groups: People 60 years and older: Two RSV vaccines, GSK Arexvy and Pfizer Abrysvo, are approved by the FDA and recommendable based on shared decision-making by healthcare providers and adults aged 60 and older.

 

What is the new drug for RSV?

The Latest in RSV Protection for Kids: An Antibody Treatment Called Beyfortus – close. Parents in the U. S. can breathe a sigh of relief: Recently, the FDA approved a new drug which can help children below 2 years get shielded from RSV throughout the viral season.

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