Serum Institute of India (SII) has applied for marketing authorisation of its COVID-19 vaccine Covishield in the European Union through its partner AstraZeneca, sources told Moneycontrol.
The source declined to share specific details on when SII-AstraZeneca has sought marketing approval in the EU, but said that European Medicines Agency (EMA) would soon update its statement.
However, the information contrasts with the EMA (European Medicines Agency) statement on June 29 which clarifies that it hasn't received any request for marketing authorisation of Covishield.
"We would first clarify that we have not received a request for marketing authorisation for Covishield at this point," said an EMA spokesperson.
"The only COVID-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria (previously COVID-19 Vaccine AstraZeneca)," the spokesperson added.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Many Indians who are vaccinated with Covishield are concerned about their travel plans to Europe, as European Union declined Green Pass or vaccine passports to travellers vaccinated with the jab produced in India. The pass is required for easy travel to and within the EU and will be launched from July 1.
EMA said that even though (SII's Covishield) may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules.
"This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process," the EMA spokesperson noted.
Covidshield vaccine, a similar version of AstraZeneca's COVID-19 vaccine Vaxzevria, is being manufactured and distributed by Pune-based SII.
Moneycontrol learnt that SII didn't apply for marketing approval in Europe earlier, as it is not its core market, where AstraZeneca is marketing the Vaxzevria and is also partly based on assumption that the WHO, the UK's MHRA and approvals in dozens of other countries including India would suffice for vaccine acceptance.
Earlier Adar Poonawalla, CEO of SII, said he has taken this up at the highest levels and hopes to resolve this matter soon, both with regulators and at a diplomatic level with countries.