Covid-19 vaccines that seek nod for emergency use authorisation

Emergency Use Authorisation is a mechanism by which regulatory authorities facilitate the availability and use of unapproved medical products such as vaccines during public health emergencies.

While several coronavirus (Covid-19) vaccines have reached advanced stages of trials, giving hope to the world that the pandemic that has killed nearly 1.6 million is about to be over, experts have warned that vaccines alone are not enough to do the job. The World Health Organisation (WHO) last week again stressed on the importance of wearing masks and following the Covid-19 guidelines after warning people that not everyone will be able to receive the vaccine early next year.

Nations are gearing up for a massive rollout to tackle the surging infections (REUTERS)

“Vaccines do not equal zero Covid. Vaccination will add a major, major, powerful tool to the tool kit that we have. But by themselves, they will not do the job,” WHO emergencies director Michael Ryan said. WHO Director-General Tedros Adhanom Ghebreyesus too cautioned against the “growing perception that the pandemic is over.”

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Meanwhile, nations are gearing up for a massive rollout to tackle the surging infections. According to the Union health ministry, eight vaccine candidates are at various stages of trials in India and are in the line for Emergency Use Authorisation (EUA). EUA is a mechanism by which regulatory authorities facilitate the availability and use of unapproved medical products such as vaccines during public health emergencies.

Here is a list of vaccine candidates that are under regulatory review for emergency useor are likely to get a nod for it:

Pfizer’s Covid-19 vaccine

The vaccine produced by Pfizer Inc. and its German partner BioNTech was submitted for emergency use authorisation in the US on Friday. The US Food and Drug Administration (FDA) said it would work quickly to authorise the vaccine for emergency use after an advisory panel voted in favor of it, after endorsing the vaccine on Thursday, according to news agency AP. In India, VK Paul, who heads the group of experts on vaccine administration for Covid-19 that advises India’s Prime Minister Narendra Modi, told Reuters that the country may still consider granting Pfizer emergency use authorisation, despite it not having conducted safety and immune response trials in India, but said that decision would be taken by the drugs regulator.

Oxford/AstraZenecaSerum Institute of India (SII), which is conducting trials of Covid-19 vaccine Covishield in India, has said it expects approval for emergency use in the next two weeks. UK’s drug regulator Medicines and Healthcare Products Regulatory Agency (MHRA) has already given a nod to the vaccine candidate.

Moderna

US drugmaker Moderna applied for emergency use authorisation for its Covid-19 vaccine on Monday. It had announced its plans to request the US FDA for an EUA for its Covid-19 vaccine, mRNA-1273, in November end.

Bharat Biotech

Bharat Biotech has been told by the Subject Expert Committee (SEC) on emergency use authorisation of Covid-19 vaccine that it needs to submit more data on its candidate Covaxin before it can be granted approval for emergency use. “While considering the application of Bharat Biotech company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis,” a source told ANI.

Remdesivir and Favipiravir

Remdesivir and Favipiravirgot Central Drugs Standard Control Organisation’s (CDSCO) emergency or restricted approval for use in June. CDSCO comes under the Directorate General of Health Services, Ministry of Health & Family Welfare.