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FDA grants approval for Novavax's COVID-19 vaccination

U.S. Food and Drug Administration (FDA) approves Novavax's (NVAX) COVID-19 vaccine, Nuvaxovid, for use in high-risk populations in the U.S. Learn more about it here.

COVID-19 vaccine Nuvaxovid, developed by Novavax (NVAX), receives approval from the U.S. FDA for...
COVID-19 vaccine Nuvaxovid, developed by Novavax (NVAX), receives approval from the U.S. FDA for use in high-risk individuals. Get the details here.

FDA grants approval for Novavax's COVID-19 vaccination

Protein-based COVID-19 Vaccine Nuvaxovid Now Approved for Older Adults in the U.S.

On the weekend, the U.S. Food and Drug Administration (FDA) gave a nod to the COVID-19 vaccine developed by Gaithersburg, Maryland-based biotech Novavax (NASDAQ:NVAX). This protein-based jab, known as Nuvaxovid, is now approved in the U.S. to shield those aged 65 years and over from COVID-19.

A Closer Look at Nuvaxovid

As a protein-based vaccine, Nuvaxovid consists of a Matrix M adjuvant that revs up the body's immune response against SARS-CoV-2. Originally, it was given emergency use approval in August 2022, with indications for individuals aged 12 and up. As of May 17, 2025, it's especially approved in the U.S. for seniors and those aged 12-64 with specific conditions.

Potential Side Effects

Although specific side effects for Nuvaxovid in seniors aren't covered in recent updates, all COVID-19 vaccines might spark temporary symptoms like pain, redness, or swelling at the injection site, fatigue, headache, and muscle or joint pain. These aches and pains usually subside in a few days without requiring medical attention, but you can use over-the-counter painkillers like paracetamol or ibuprofen to alleviate them.

Distribution Plans

No specific details about the distribution plans for Nuvaxovid among seniors are available in recent updates. However, standard vaccine distribution channels, including pharmacies, healthcare providers, and vaccination centers, are likely to distribute the vaccine.

Considerations and Challenges

The process to secure full FDA approval for Nuvaxovid has been fraught with uncertainties, including delays in decision-making and calls for additional data. Such uncertainties have raised questions about the vaccine's distribution timeline and scope[3]. Despite these difficulties, the vaccine's approval for individuals aged 65 and over highlights its potential to bolster protection for vulnerable populations, though comprehensive distribution plans remain less detailed in the recent reports.

Immune System Concerns

For seniors who might also be immunocompromised, it's essential to take their unique health conditions and any ongoing treatments into account when deciding on vaccination strategies. This includes understanding how their medications could impact vaccine effectiveness and adhering to evidence-based guidelines for vaccination[2].

Science and health-and-wellness are intertwined in the approval of the protein-based Nuvaxovid COVID-19 vaccine for older adults in the U.S. This vaccine, with its Matrix M adjuvant enhancing the immune response against SARS-CoV-2, could potentially offer increased protection for vulnerable populations, but it's crucial to consider the unique health conditions and ongoing treatments of seniors who might also be immunocompromised when making vaccination decisions.

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