The Pfizer-BioNTech Covid-19 vaccine has become the first vaccine to receive WHO validation for emergency use. This means the poorer countries may get access to the shots soon.

Every country that has a drug regulatory agency will have to issue its own approval for any coronavirus vaccine, but countries with weak health care systems usually rely on WHO to vet the shots.

The WHO said the decision to issue its first emergency use validation for a coronavirus vaccine “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.”

It also said its review found the Pfizer-BioNTech vaccine, which has already received clearance in the United States, Britain, the European Union and a dozen other countries, “met the must-have criteria for safety and efficacy set out by WHO”.

BioNTech-Pfizer’s coronavirus vaccine’s requirement to be stored at ultra-frozen temperatures is a big hurdle for developing countries where the required freezers and reliable electricity supply may not be available.

The coronavirus vaccine by Pfizer, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

Rural areas in India and many poorer countries are likely to have a hard time in Pfizer’s coronavirus vaccine distribution. Plus, many hospitals in big cities also do not have the facilities to store vaccines at minus 70 degrees Celsius (-94 F) or below.

“This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible,” WHO said, adding that it was “working to support countries in assessing their delivery plans and preparing for use where possible”.

In India, PM Narendra Modi had held a meeting with chief ministers of all the states and Union Territories to review the coronavirus situation and asked them to start working on cold storage facilities for the coronavirus vaccine.

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He said he believes trials will show his firm has achieved a vaccine efficacy similar to Pfizer BioNTech and Moderna vaccines.

Earlier, several reports suggested that AstraZeneca vaccine may not be as good as the one made by Pfizer, already being distributed in the UK and other countries. Partial results suggest that the AstraZeneca shot is about 70 percent effective for preventing illness from coronavirus infection, compares to the 95% efficacy reported by Pfizer and its German partner BioNTech.

“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” the chief executive said, while saying only that data would be published at “some point”.

The United Kingdom government announced on December 23 that the developers of the Oxford-AstraZeneca vaccine had submitted their data to the Medicines and Healthcare products Regulatory Agency (MHRA). Approval is expected to be granted to roll out the jab on January 4.

The Pfizer-BioNTech vaccine was the first coronavirus shot to be authorised for use by the UK’s independent medicines regulator and has been given to 600,000 of the country’s most vulnerable people since last month.

Earlier trials had shown different outcomes in the AstraZeneca shot’s efficacy. The vaccine initially showed an average 70 per cent effectiveness but that level jumped to 90 per cent depending on the dosage.

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US regulators are now weighing in whether to grant emergency use authorisation for Moderan vaccine. A panel of outside advisers to the US Food and Drug Administration encouraged the emergency use of Moderna vaccine.

Early data from the trials of the coronavirus vaccine candidate being developed by Oxford University and AstraZeneca show two full doses of the vaccine give better immune response than the previously tried one full dose and a half-dose booster.

Developers of the vaccine candidate have already published late-stage trial results showing higher efficacy when a half dose is followed by a full dose, compared to a two full-dose regime.

Meanwhile, AIIMS- Delhi is reportedly unable to find enough number of volunteers for the Phase 3 trials of Covaxin, a coronavirus vaccine candidate being developed by Bharat Biotech and ICMR. AIIMS officials have observed people are unwilling to participate in the trials thinking a vaccine would be anyway be available soon.

The All India Institute of Medical Sciences (AIIMS) in Delhi is one of the sites conducting the final phase of the trial of Covaxin and it needs around 1,500 volunteers.

“We wanted 1,500-2,000 participants but so far, we have been able to recruit only around 200 participants. People are unwilling to participate in the exercise thinking why take part in a trial when a vaccine would be available soon for everyone,” Dr Sanjay Rai, professor at AIIMS and also the principal investigator of the study, said.

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