Moderna announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved its new flu vaccine, nearly six months after the regulator initially rejected the application for review.
Moderna announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved its new flu vaccine, nearly six months after the regulator initially rejected the application for review.
The US-based pharmaceutical company stated in a press release that its first mRNA-based flu vaccine, named mFLUSIVA, is approved for use by all adults aged 50 and older.
According to the release, Moderna expects mFLUSIVA to become available to eligible populations in the United States during the 2026–2027 respiratory disease season.
Earlier in February, Moderna publicly stated that federal regulators deemed its clinical trials insufficient and rejected the application for the new vaccine's review. However, a week later, the FDA reversed its previous position following a meeting which Moderna described as 'constructive.'
The new drug utilizes mRNA technology, which was criticized by health official Robert F. Kennedy Jr., a known vaccine skeptic. He had previously halted funding for federal research grants supporting mRNA development.
Under Kennedy's leadership and President Donald Trump's administration, the FDA called for a review of approval procedures for certain vaccines, including flu vaccines, and proposed changes to federal policy, causing widespread concern among healthcare workers and public health specialists.
During his first term, Trump referred to mRNA technology as a 'miracle of modernity.' This technology was used during the Covid-19 pandemic to rapidly create immunity against the fast-spreading disease and was recognized for saving millions of lives. Covid-19 vaccines are considered safe and effective by global health organizations and protect against the most severe forms of infection.
The Indian Central Drugs Standard Control Organisation (CDSCO) has granted approval for the use of the QDENGA vaccine from the Japanese pharmaceutical company Takeda in India. This vaccine is the first in the country designed to combat dengue fever.
Approval has been granted for individuals aged 4 to 60 years. Vaccination is expected to commence shortly. The introduction of this vaccine has raised several questions among the public, including the possibility of lifelong protection after a single injection, the presence of side effects, and the identification of the target audience.
Before answering questions about the vaccine, it is important to understand the disease itself. Dengue is caused by bites from Aedes mosquitoes. The dengue virus has four serotypes (DENV-1, DENV-2, DENV-3, DENV-4), and an infected mosquito can carry any of them, leading to human illness. Although the illness usually resolves on its own within a few days, it can cause death, for example, due to shock syndrome caused by a rapid drop in platelet count.
The main goal of introducing the vaccine is to reduce the number of cases and mortality from dengue.
Professor Subhash Giri, Director of the Department of Medicine at Ram Manohar Lohia Hospital in Delhi, commented on the issue of lifelong protection. He clarified that the vaccine helps reduce the risk of severe illness and the need for hospitalization. However, the drug's effectiveness depends on strict adherence to the established dosing schedule. This vaccine requires two doses administered three months apart.
Dr. Giri emphasized that vaccination does not mean people can neglect dengue prevention measures. The advantage of the vaccine lies in reducing the probability of developing severe symptoms, but it does not guarantee complete absence of the disease.
According to Dr. Subhash, vaccines are developed after extensive research and trials, so no serious side effects have been observed. Most commonly noted reactions include pain at the injection site, mild fever, headache, or fatigue, which pass within a few days. Upon the availability of the vaccine, all eligible individuals are recommended to undergo the procedure upon the advice of their doctor, ensuring the full course is completed, as one dose is insufficient to provide complete protection.
Regarding the necessity of vaccination for healthy individuals, Dr. Subhash noted that immunity does not play a decisive role in the development of dengue, as the disease can affect anyone, although symptoms may vary. The goal of the vaccine is to minimize the threat of severe infection. The decision to vaccinate must be made by a physician and comply with national guidelines, but for the elderly and patients with other serious illnesses, vaccination as prescribed by a doctor is extremely important.
