EU ‘Green Pass’ plan leaves Covishield out, serum not seeking approval

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Covishield is derived from AstraZeneca shooting, called Vaxzevria outside of India. As such, virologist Shahid Jameel said The science of yarn, Vaxzevria and Covishield are qualitatively similar.

However, the Serum Institute in Pune, which manufactures Covishield in India with a license from AstraZeneca, has not sought approval of the vaccine by the European Medicines Agency (EMA).

EMA confirmed The science of yarn to date, it has not received an application for approval for Covishield. An email to Serum Institute had not elicited a response at the time of posting.

However, the CEO of the Serum Institute, Adar Poonawala had said in September of last year, the company and the Indian government had “committed to reserving half of the shares of the company … So the Serum Institute did not have to seek approval from the EMA .

Covishield is an important part of the international COVAX alliance. Vaccines for this initiative must have WHO approval. On the other hand, the ‘Green Pass’ initiative is based on the approval of the EMA.

Covishield and Vaxzevria

The EMA regulates drugs and medical products in European countries. The nations “passport to vaccines” program, officially called the “Green Pass”, has approved only four vaccines, according to Economic times. These are Vaxzevria (Oxford-AstraZeneca), Comirnaty (Pfizer-BioNTech), Spikevax (Moderna) and Janssen-Johnson & Johnson.

Iceland previously reopened its borders to international travelers after vaccinating most of its small population of 3.6 lakh (2019), allowing anyone who received a WHO-approved vaccine to enter the island country . Covishield has WHO accreditation. However, the “Green Pass” program only supports vaccines approved by the EMA.

Doses of the Oxford-AstraZeneca COVID-19 vaccine – Vaxzevria – are produced largely by three companies: Serum Institute of India, SK Biosciences in South Korea and the four from AstraZeneca. manufacturing sites.

WHO has given an emergency wink at eight So far, COVID-19 vaccines, including AstraZeneca’s Vaxzevria and corresponding “versions” from the Serum Institute and SK Biosciences. India’s other major COVID-19 vaccine, Covaxin, has not been approved by either the WHO or the EMA.

Jameel, director of the Trivedi School of Biosciences, Ashoka University, Haryana, said The science of yarn that Vaxzevria and Covishield are biologically equivalent despite being produced by different manufacturers. “They’re just made in different locations using the same manufacturing and quality assurance and quality control protocols,” he said.

In November 2020, Serum Institute launched a clinical test to test the safety of Covishield and compare its immunogenicity with AstraZeneca’s Vaxzevria, with 1,600 trial participants. The results of this trial have not yet been published. However, the immunogenicity data, available from the Central Drug Standards Control Organization of India, suggested that Vaxzevria and Covishield generate a comparable level of antibodies. (Note that the trial predates the rise of the delta variant in India.)

The study recruited around 1,600 participants. Its administrators assigned 1,200 people to a group they would follow to assess the safety of the vaccine. The other 400 were assigned to a group to assess the immunogenicity of the vaccine. These were further divided – 300 received Covishield and 100 received Vaxzevria.

The antibody titer against the spike protein of the novel coronavirus was 9,988.1 in those who received Covishield and 6,738.5 in those who received Vaxzeria at 29 days after receiving the first dose, and up to 33,331.6 and 33,263.6 after 57 days. Note that this data is only based on a quarter of the trial participants. Serum Institute has yet to release the complete data after 57 days or the safety cohort data.

In one February 2021 report of Covishield, after the Serum Institute applied for an “emergency use” authorization, WHO experts also noted that the different parameters of the immune response induced by the two vaccines – Covishield and Vaxzevria – were comparable . Interestingly, they admitted the Serum Institute’s candidacy after also looking at the data from Vaxzevria’s trial.

Receipt of applications

Every major drug regulatory body, like the EMA or the Drug Controller General of India, receives requests for approval from manufacturers. Different manufacturers of the same vaccine must submit separate applications. One of the reasons for this is that the approval process involves an inspection of the manufacturing facilities.

For example, earlier last week, a team of WHO investigators visited Ufa in southern Russia, where some of the country’s Sputnik V vaccine manufacturing facilities are located. Investigators reported issues in a factory which Russia claimed had been resolved. Until all issues are resolved, approval may not be granted.

Bharat Biotech, the maker of Covaxin, had encountered similar problems in Brazil, whose health authorities had reported problems at manufacturing facilities in India. Although the issue was subsequently resolved, authorities had not rejected the company’s overall claim itself.

Murali Neelakantan, senior lawyer at amicus and former global general counsel for Cipla, said the EMA has approved each of AstraZeneca’s projects. manufacturing sites that would make Vaxzevria.

“The AstraZeneca website lists sites in South Korea, China, the Netherlands, the UK, Belgium and the US. The Serum Institute should explain why it is not listed here, ”he said. “Was it because SII did not have a license from AZ to sell in the EU? Has the issue of vaccination certificates not been taken into account? “

Following public reaction to Covishield’s exclusion from the “Green Pass”, Adar Poonawalla, CEO of the Serum Institute tweeted on June 28: “I hope to resolve this matter soon, both with the regulators and at the diplomatic level with the countries.”

Relaxation of restrictions

The emergence of new variants of the virus that causes COVID-19 – but especially the WHO-recognized “worrisome variants”, recently dubbed alpha, beta, gamma and delta – has severely restricted international travel. Although entry rules differ from country to country, the immunization status of travelers has an important role to play in facilitating travel.

For example, there are two two different restriction levels for passengers traveling from India to France. All travelers are required to produce a negative RT-PCR report upon boarding and will be retested upon arrival in France. Those who have been vaccinated will have to “commit to self-isolate for seven days.” Those who have not been vaccinated will have to undergo a “mandatory 10-day quarantine supervised by the security forces”.

France only considers vaccines approved by the EMA. And since none of the vaccines approved for use in India – Covaxin, Covishield and Sputnik V – have EMA approval, even vaccinated Indians will be considered “unvaccinated,” according to the. French government rules. The situation is the same in Germany.

In fact, with the “Green Pass” program, which is scheduled to be launched on July 1, this will be the case in all the countries of the European Union.

With contributions from Vasudevan Mukunth. This article has been updated at 1:16 p.m. on June 28, 2021 to include details of the Serum Institute’s transition trial in India and quotes from Murali Neelakantan.

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