{"id":603102,"date":"2024-05-31T11:07:00","date_gmt":"2024-05-31T15:07:00","guid":{"rendered":"https:\/\/platohealth.ai\/moderna-wins-fda-approval-for-rsv-vaccine\/"},"modified":"2024-06-01T09:03:13","modified_gmt":"2024-06-01T13:03:13","slug":"moderna-wins-fda-approval-for-rsv-vaccine","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/moderna-wins-fda-approval-for-rsv-vaccine\/","title":{"rendered":"Moderna wins FDA approval for RSV vaccine","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.<\/p>\n

The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot\u2019s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season<\/a> in the U.S.<\/p>\n

RSV can cause severe disease in infants, the elderly and immunocompromised individuals, in some cases leading to death<\/a>. The virus typically circulates during the fall and winter in the Northern Hemisphere, similar to the seasonal pattern for influenza and COVID-19.<\/p>\n

\u201cRSV is finally being appreciated as an adult disease with a considerable morbidity, mortality, and impact on hospital capacity,\u201d said Amesh<\/span> Adalja<\/span>, an assistant professor at the Johns Hopkins Bloomberg School of Public Health and an infectious disease physician, in a May interview. \u201cThe virus is finally being taken seriously, hopefully, more vaccine options will increase uptake.\u201d<\/p>\n

Scientists for decades struggled to develop a safe and effective vaccine for RSV. Their efforts were unsuccessful until a breakthrough in 2013<\/a> paved the way for development of the current crop of vaccines that are now reaching the market.<\/p>\n

British drugmaker GSK was the first to gain approval in the U.S. with its vaccine Arexvy<\/a> cleared for use in older adults last year. Pfizer followed weeks after with its<\/a> shot Abrysvo<\/a>. Later last summer, the FDA granted Abrysvo an additional approval for maternal use<\/a><\/p>\n

Demand has been high. In the first year it was approved, Arexvy brought in 1.2 billion pounds, or about $1.5 billion, for GSK, growing the company\u2019s vaccine business. Pfizer\u2019s shot has also done well, although sales haven\u2019t been as strong as GSK\u2019s. The company reported $515 million<\/a> in Abrysvo sales in 2023.<\/p>\n

Moderna plans to compete. It will have to, as declining sales<\/a> of its popular COVID vaccine have put pressure on the company to deliver growth from other products.<\/p>\n

Like its COVID shot, mResvia is built around messenger RNA. It trains the body to recognize the \u201cprefusion\u201d F protein of RSV, similar to Pfizer\u2019s and GSK\u2019s vaccines.<\/p>\n

Moderna points to mResvia\u2019s preparation and delivery as advantages versus the competition. On a recent earnings call, Moderna CEO St\u00e9phane Bancel said the shot could ease \u201cpersonnel burden on pharmacies\u201d with a prefilled syringe formulation versus its competitors<\/a>\u2019 more-complex-to-administer shots.<\/p>\n

\u201cOur pre-filled syringe presentation is ready to use straight out of the box,\u201d said Bancel<\/span> on the May 2 call.<\/p>\n

The CDC meeting in June will be important, as contracts with pharmacies are likely to be finalized after the agency\u2019s recommendations. Due to RSV\u2019s seasonal pattern, the late summer-to-fall period is when immunization campaigns are prepared.<\/p>\n

This was borne out in the first quarter this year, as Arexvy and Abrysvo sales declined from the three months between October and December.<\/p>\n

\u201cIt very much appears like the RSV vaccination market is following a seasonal trend, so you expect the dynamics in Q4 versus Q1 to be different,\u201d said Pfizer\u2019s Chief U.S. Commercial Officer Aamir Malik on a first quarter earnings call.<\/p>\n

Moderna expects the total RSV vaccine market to grow to between $6 billion and $8 billion in annual sales.<\/a> There is \u201cdebate\u201d on how much market share Moderna could gain considering it\u2019s third to market, Jefferies analyst Michael Yee wrote in a recent note to clients<\/p>\n

\u201cI think [Moderna] may be a victim of the fact that it is later to the market than its competitors, as well as the fact that there is an irrational opposition to mRNA vaccines,\u201d said Adalja.<\/p>\n

Dan Barouch<\/a>, an immunologist and professor of medicine at Harvard Medical School, has the opposite view. He thinks Moderna\u2019s shot will perform well given the demand seen with other RSV vaccines, and doesn\u2019t expect skepticism over COVID shots to affect uptake.<\/p>\n

Moderna said it expects net sales of about $4 billion in 2024<\/a> between its COVID and RSV vaccines, but did not give specific guidance for mResvia.<\/p>\n

\u201cIf its efficacy or durability is shown or suggested to be better than Pfizer and GSK\u2019s versions, it may have an opening,\u201d Adalja said.<\/p>\n