Novavax vaccine gets WHO approval for emergency use

GENEVA • The World Health Organisation (WHO) on Tuesday approved a Covid-19 vaccine made by US pharmaceutical giant Novavax for emergency use, after the European Union medicines regulator gave it the green light.

The European Medicines Agency had assessed and approved Nuvaxovid on Monday.

It is made from a more conventional technology than others already approved, which has led officials in Brussels to express hope that this will help persuade those hesitant about vaccination to come forward.

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

It is a tried and tested approach, used for decades to vaccinate people against diseases including hepatitis B and whooping cough.

A so-called emergency use listing (EUL) by the WHO paves the way for countries worldwide to quickly approve and import a vaccine for distribution.

It also opens the door for them to enter the Covax global vaccine-sharing scheme, set up to provide equitable access to doses around the world and particularly in poorer countries.

The two-shot Nuvaxovid jab is the 10th Covid-19 vaccine issued an EUL by the United Nations health agency. WHO said Nuvaxovid was around 90 per cent effective at 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, WHO's Strategic Advisory Group of Experts (Sage) on Immunisation recommended the new vaccine for use among people over the age of 18, 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," it warned.

Novavax said yesterday that Sage had also recommended a third dose of its vaccine, NVX-CoV2373, for immunocompromised persons.

Nuvaxovid can be kept at refrigerated temperatures of between 2 deg C and 8 deg C, giving it a logistical advantage in difficult-to-access regions over the mRNA vaccines, which must be stored at ultra-low temperatures.

Among the Covid-19 vaccines already handed a WHO EUL is the Covovax shot, a version of Novavax's vaccine made by the Serum Institute of India under licence from the US-based company. It was authorised last Friday.

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

The WHO also recently resumed evaluating the Russian-made Sputnik V vaccine against Covid-19, after several months in limbo, as it waited for additional data.

Dr Rogerio Gaspar, head of the WHO's regulation and pre-qualification department, said on Monday the WHO would begin assessing the quality of the data received next month, and aims to carry out inspections on site in February.

He told reporters he could provide "no date on approval because the approval will depend really... on the quality of the information".

Neither US nor EU medicine watchdogs has so far granted authorisation for Sputnik V, which has been used in Russia and some other countries since late last year.

AGENCE FRANCE-PRESSE, REUTERS