Novavax Files for EUA as Covid Market Sees more Moves

04.01.2022 - Between the Christmas and the New Year’s bells and on both sides, the international pharmaceutical and healthcare sector continued battling the coronavirus pandemic. In one of the most watched developments – most of which took place in the US – Novavax finally fulfilled its pledge to file final data to the US Food and Drug Administration (FDA) for Emergency Use Authorization of its protein-based Covid-19 vaccine during the year’s fourth quarter.

The move had been delayed twice as the US biotech tussled with the FDA over clinical trial methodology. The health watchdog has not signaled when it might review the data, but some commentators thought it possible that by February the US could have its fourth vaccine on the market alongside the mRNA shots made by Pfizer-BioNTech and Moderna and the viral vector product manufactured by Johnson & Johnson subsidiary Janssen.

The Novavax shot is derived from the spike protein of the original strain of the coronavirus and is bolstered by an adjuvant. The European Medicines Agency (EMA) approved the candidate in December following a months-long rolling review, and the UK’s Medicines and Health Regulatory Authority (MHRA) greenlit it in November.

Last month, Novavax said it planned to begin delivering the vaccine to the EU in January. Brussels has ordered 100 million doses, with an option to order 100 million more. Supplies for the region will be produced by the Serum Institute of India, with which the company based in the state of Maryland has a partnership.

FDA approves Merck and Pfizer oral treatments.

With a nod to its cautious advisory panel, the FDA granted EUAs to US Merck & Co’s as well as to Pfizer’s oral Covid treatment. Both are recommended for people at a high risk of developing severe Covid-19. While Merck’s molnupiravir (brand name Lagevrio) was seen to be only about 30% effective in preventing hospitalization, Pfizer’s nirmatrelvi (Paxlovid) was claimed to reduce that risk by 89%.

The US health agency also authorized the first drug for widespread use in preventing Covid in people with weakened immune systems who cannot be adequately protected by vaccines. The antibody treatment developed by AstraZeneca and branded as Evusheld reportedly offers protection for an estimated six months, more than other monoclonal antibody treatments currently administered to this high-risk group.

German health ministry orders Paxlovid

The EMA has already granted conditional marketing approval for molnupiravir but it has not dealt with Paxlovid. Nevertheless, Germany’s new federal health minister Karl Lauterbach, days after taking office, ordered more than 1 million treatment units of the Pfizer drug in an effort to be ready when the country’s federal institute for drugs and medical products Bfarm awards the treatment emergency use status. Initial supplies should arrive during January, reports said.

FDA amends EUA status for Comirnaty in adolescents

In the first week of January, the FDA amended the EUA for the Pfizer-BioNTech Covid vaccine Comirnaty to be given to adolescents aged 12 to 15 years. The authorization shortens the recommended time between completion of the initial two-dose course and a booster dose to “at least five months” and allows for a third primary series dose to be offered to certain immunocompromised children 5 to 11 years of age.

The FDA said it based its decision on a review of real-world data from Israel in the same age cohort, adding that no new safety concerns following a booster had become evident. Additionally, no new cases of the heart conditions myocarditis or pericarditis were reported and no new safety concerns emerged in those 16 and older who received a booster dose at least five months following the two initial doses.

Pfizer and BioNTech have gone back to the lab to find a new vaccine formulation for Comirnaty that can sufficiently protect children under five years of age. The American and German partners announced last autumn that the first candidates tested did not produce the desired result.

Covid triggers drop in US life expectancy          

As a new wave of Covid washes across the US, the Centers for Disease Control (CDC) said at the end of 2021 that the country’s life expectancy declined by nearly two years during 2020, from 78.8 years in 2019 to 77. It was the biggest drop since World War II. Previously, the CDC had forecast a decline of 1.5 years. Around 350,000 people died from Covid in the US in 2020.

Covid was also the third leading cause of death in the US in 2020, and it was the "primary driver” in the decline in life expectancy and the increase in mortality, the CDC said. Broken down by ethnic origin, the death rate increased 43% for Hispanic males, 28% for African-American males, and 13 % for Caucasian males. 

Author: Dede Williams, Freelance Journalist