As international travel slowly opens up, countries are preparing standard protocols for issue of visa and travel documents. While United States is going ahead with its list of approved vaccines, EU has a different set and within EU many countries
EMA the agency of the European Union responsible for the evaluation and supervision of medicinal products has approved only four Covid 19 Vaccines so far Comirnaty (BioNtech – Pfizer) Moderna, Vaxzevria (Oxford – Astra Zeneca) Jansen (Johnson & Johnson).
Adar Poonawalla, Chief Executive Officer (CEO) of the Serum Institute of India (SII) today said that he has taken up the issue of exclusion of SII’s Covishield in the list of approved vaccines for the EU green pass at the highest level.
“I realise that a lot of Indians who have taken Covishield are facing issues with travel to the E.U. I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries,” Poonawalla tweeted.
On the other hand, Bharat Biotech and the World Health Organization held a ‘pre-submission’ meeting last Wednesday for international emergency use listing (EUL) of Covaxin, its COVID-19 vaccine. The meeting was to give the company a chance to receive guidance from WHO authorities before the final submission.
Last month Bharat Biotech said it had already submitted 90 per cent of the required paperwork. The Hyderabad-based manufacturer also said it was confident of getting the nod “given its experience of getting its other vaccines pre-qualified by WHO”.
The digital ‘Vaccine Passport’ recognises the Vaxzevria version of the AstraZeneca vaccine that is produced in the UK and Europe, and approved by the European Medicines Agency (EMA). However, Covishield, manufactured by the Serum Institute of India and Covaxin manufactured by Bharat Biotech has not yet been recognised by the EMA, despite being from the Astra Zeneca stable.
Adar hopes to resolve the matter soon, but a lot of it will depend on the clout that Astra Zeneca can throw in, along with the influence that Govt of India can wield. On the other hand, Bharat Biotech is pinning hopes for a quick approval for a EUL by WHO.
WHO’s emergency use listing, or EUL, is a risk-based procedure for assessing and listing new, or unlicensed, products that can be used during public health emergencies. As of now only seven vaccines have been given EULs, including the AstraZeneca-Oxford University shot produced and sold in India as Covishield. Also on the list are the Pfizer and Moderna shots that the government has said it is working to bring to India.
As of now, travel from India is restricted by most countries including high traffic flow to the Middle East. UAE is insisting of all Indians who land in their country to undergo institutional quarantine. Surprisingly, Chinese Vaccines have made it to the list, but GCC countries are cagy about letting in people who have been vaccinated by it.
The absence of an Indian vaccine from the list of approved jabs will create hurdle for people wanting to travel. EU member states that issue the Green Pass must accept these four vaccines, but are free to accept others as well.
The process of granting of an EUL involves rigorous assessment of clinical trial data – as well as data on safety, efficacy and quality – and a risk management plan. As per WHO, the submission for a vaccine EUL needs to follow a specific format that must include information on manufacturing quality data, and non-clinical data and clinical data. It must also include a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as it is available.
Most importantly for consideration for EUL, the primary efficacy endpoint estimate should be at least 50 per cent. In simple English, this means any vaccine looking to get an EUL from WHO must be at least 50 per cent effective.
