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WHO approves Novavax as 10th authorized COVID jab

Vials with a sticker that read
Vials with a sticker that read “COVID-19 / Coronavirus Vaccine / Injection only” and a medical syringe are visible in front of a Novavax logo shown in this illustration. Reuters-Yonhap

The World Health Organization on Tuesday approved a COVID vaccine made by US pharmaceutical giant Novavax for emergency use, after the European Union’s drug regulator gave it the green light.

The European Medicines Agency evaluated and approved Nuvaxovid on Monday.

It’s made using more conventional technology than others already approved, which has led Brussels officials to express hope that it will help persuade those hesitant about vaccination to come forward.

The jab uses traditional technology involving proteins found on advanced coronavirus proteins that trigger an immune response.

It is a proven approach, used for decades to immunize people against diseases such as hepatitis B and pertussis.

A WHO Emergency Use List (EUL) paves the way for countries around the world to quickly approve and import a vaccine for distribution.

It also opens the door for them to enter the Covax global vaccine sharing system, set up to provide equitable access to doses around the world and especially in the poorest countries.

The two-shot Nuvaxovid vaccine is the 10th COVID vaccine issued by the United Nations health agency.

90% efficient

WHO said Nuvaxovid was around 90% effective in reducing symptomatic cases of Covid-19 in two major clinical studies, one in Britain and the other in the United States and Mexico, involving more than 45,000 people.

In a separate document, the WHO Strategic Advisory Group of Experts on Immunization recommended the use of the new vaccine in people over 18 years of age, with an interval of three to four weeks between the two doses.

“The vaccine should not be administered with an interval of less than three weeks,” he warned.

It can be stored in the refrigerator at temperatures between 2 and 8 degrees Celsius, giving it a logistical advantage in hard-to-reach areas over mRNA vaccines, which must be stored at ultra-low temperatures.

Among the COVID vaccines already handed over to a WHO EUL is the Covovax vaccine, a version of the Novavax vaccine manufactured by the Serum Institute of India under license from the US-based company.

It was cleared on December 17.

Also on the list are mRNA vaccines produced by BioNTech / Pfizer and Moderna, Johnson & Johnson, AstraZeneca (which is double counted for versions made in Europe and India), Indian-made Covaxin, and Sinopharm and Sinovac made. Chinese. .

The WHO also recently resumed evaluation of the Russian-made Sputnik V vaccine against COVID-19, after several months in limbo, pending further data.

Rogerio Gaspar, head of the WHO’s regulatory and prequalification department, said on Monday that the United Nations health agency would start assessing the quality of data received next month and aim to conduct on-site inspections in February.

He told reporters he could not provide “any approval date because approval will really depend… on the quality of the information.”

So far, neither the US nor EU drug watchdogs have authorized Sputnik V, which has been in use in Russia and other countries since late 2020 (AFP)