The US Food and Drug Administration (FDA) expressed concerns over the possible risk of heart inflammation from the Novavax COVID-19 vaccine, Reuters reported on Friday.
On its side, the company said that it could reduce the chances of these risks.
The FDA said: "These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines."
After the FDA's letter, the shares of the company dropped by 14%
Novavax also responded saying: "Based on our interpretation of all the clinical data supporting NVX-CoV2373 ... we believe there is insufficient evidence to establish a causal relationship."
Last year, Novavax Inc, and Serum Institute of India applied to the World Health Organization (WHO) for having the emergency use approval for their COVID-19 vaccine, Novavax.
The corporation highlighted that the earliest productions of the vaccine will be dedicated to poor, and medium-income countries as the rest of rich and developed countries are depending on a wide collection of other vaccines to secure their residents.
The WHO may back the vaccine to be shipped to several countries that depend on WHO guidance for their pandemic related measures.
In the same context, Novavax applied their documents to several countries to have a domestic approval of emergency use in them such as India, and Indonesia.
The latest approved COVID-19 vaccine by the international organization were the Chinese Sinopharm, and Sinovac.
In a reported released by the advisory board of the WHO about Sinopharm, the group of experts assured the effectiveness of the two-dose vaccine for adults aged between 18 and 59 years old with 90%.
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