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Novavax Delays Its COVID 19 Vaccine’s Emergency Use Authorization Submission To FDA Till The Fourth Quarter

Recently Novavax announced that it is going to delay its emergency usage authorization request of its Coronavirus vaccination to the FDA till the fourth quarter. The company’s shares fell 10% after the announcement.

Novavax has filed for emergency use authorization in the Philippines, Indonesia, and India with the WHO. Once WHO approves the vaccine, its distribution and production will start at a massive scale and it will also be allowed to be part of global initiatives.

In several clinical trials, it was concluded that a booster shot after the administration of the required 2 doses of an approved vaccine provides better protection against the Coronavirus, especially its Delta variant. The research concluded that the administration of the Novavax booster shot 6 months after the administration of the 2 doses protects those with weaker immunity.

Novavax Delays Its COVID 19 Vaccine’s Emergency Use Authorization Submission To FDA Till The Fourth Quarter

Even with the delay of submission, Novavax says that it will produce 100000000 doses of its vaccine per month towards the end of the third quarter. It will become 150000000 by the fourth quarter.

Scientists, in the meantime, are debating the requirement of a booster shot. CDC and FDA recommend that it is not necessary for the time being. They also warn against the trend of people making a decision on their own in the matter. Still, certain States and counties have decided to accommodate those who request it.

Novavax Delays Its COVID 19 Vaccine’s Emergency Use Authorization Submission To FDA Till The Fourth Quarter

The country is now considering the possibility of authorizing the third dose. Studies show that a third dose will help those with compromised immune systems. Their bodies don’t generate a sufficient number of antibodies even after receiving two doses of a vaccine. Those who have had an organ transplant, HIV, or cancer patients fall in the category of vulnerable people.

As per the health professionals, providing a booster shot to those who have a compromised immune system is very important as these people remain vulnerable even after receiving the two shots of the approved vaccines. Officials are working in this direction. And they will authorize the third shot as early as possible. This, for them, is a priority.

People with compromised immunity comprise only 2.7% of the adult population of the country. But 44% of breakthrough infections ( when a person who has been fully vaccinated gets infected with the coronavirus) that lead to hospitalization are seen among them.

Certain small studies show that up to 80% of immuno-suppressed patients did not have a sufficient number of antibodies in their body even after receiving the two shots. Up to 50% of them started developing antibodies after a booster shot.

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Countries like France are already administering booster shots to people who have cancer or HIV. Last month, Israel had announced that it will offer booster shots to those above 60. Studies show that vaccine-induced immunity becomes weaker in the elderly.

Certain sections of health professionals are calling for the speedy authorization of a third shot. Certain immuno-suppressed people are even availing the same on their own.

Agencies like WHO, on the other hand, argue against such a campaign. According to it, the goal of the world should be to eliminate the virus from all countries. It cannot accept a situation where countries that used 50% of the global supply of vaccines use more. Such calls would widen the vaccine gap between rich and poor countries. Till May, wealthy nations were able to administer 50 doses for every 100 people. And for poorer countries, it is 1.5.

The trend should be reversed. From now, low-income countries should get a larger share of vaccines, says WHO.

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