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October 6, 2021

Coronavirus company news summary – EMA authorises third Moderna shot for immunocompromised – J&J seeks FDA approval for booster dose

By Chris Lo

The European Medicines Agency (EMA) has authorised a third shot of the Moderna Covid-19 vaccine (Spikevax) for severely immunocompromised individuals above 12 years of age. The EU agency recommended the booster shot at least 28 days after the second dose. The move comes after several studies have indicated that a third dose will benefit immunocompromised people. Moderna has received emergency authorisation for use of its mRNA vaccine in more than 50 countries.

Johnson & Johnson (J&J) has submitted data to the US Food and Drug Administration (FDA) seeking emergency use authorisation for a booster shot of its Covid-19 vaccine among adults. The submission includes recent results from the Phase III ENSEMBLE 2 study. The study found that a booster dose given 56 days after the primary dose provided 94% protection against symptomatic Covid-19 in the US. The booster shot also demonstrated 100% protection against severe Covid-19, at least 14 days after inoculation. J&J plans to submit the data to other regulators.

EmphyCorp has announced that its non-steroidal N115 nasal spray has completed Phase III clinical trials for Covid-19, long Covid-19 and pulmonary fibrosis. In a trial with active Covid-19 patients, N115 lowered viral numbers below 10,000 viral genome copies by day 6.4, compared to 10.3 days for untreated patients. For Covid-19 long haulers, N115 clinically and significantly reduced coughing/sneezing, reduced headaches and body aches, and improved breathing.

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