Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.

By Kamal Choudhury (Reuters) -Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.

Novavax finally won approval of a Covid-19 vaccine after facing setback after setback that caused the stock to plunge more than 50% in the past year.The stock surged 20% to $8.10 in early trading Monday.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.

The LP.8.1 variant of the SARS-CoV-2 virus differs from the JN.1 family that previous vaccines had been designed to target, and has surpassed JN.1 as the variant circulating most widely worldwide.

Since the COVID-19 pandemic, there has been a decline in U.S. vaccine uptake, while widespread misinformation and distrust make it challenging to craft effective public health responses.

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions -- by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters.

Overall, women who received a COVID vaccine had a 19% greater risk of increase in menstrual cycle length as compared to unvaccinated women or women in pre-vaccination time periods (summary relative risk [sRR], 1.19; 95% confidence interval [CI], 1.11 to 1.26).

This vaccine did previously have emergency approval by the FDA for use but can now be marketed in the U.S. for use, the letter said.

At long last, Novavax has secured a full FDA approval for its protein-based COVID-19 vaccine, though not in the broad population the company had originally sought. | The FDA has approved Novavax’s COVID vaccine in adults ages 65 years and older and in people between the ages of 12 and 64 who have at least one underlying health condition that puts them at high risk for severe COVID outcomes.

The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.

JN.1 may not be more severe, but it spreads fast, and that’s reason enough to stay alert. Across Asia, the priority is clear: stay prepared, stay informed, and use lessons from past outbreaks to keep ahead of the virus.