Bharat Biotech must address WHO suspension on procuring Covaxin through UN, says foreign ministry
The ministry said that the vaccine maker should avoid any situation that might lead to cancellation of Covaxin's emergency use listing.
Nearly a month after the World Health Organization’s decision to suspend the supply of Covid-19 vaccine, Covaxin, through United Nations procurement agencies, the Ministry of External Affairs said that its manufacturer Bharat Biotech should address the matter immediately, PTI reported on Thursday.
Foreign Secretary Harsh Vardhan Shringla reportedly made the observation in a communication to VK Paul, the convenor of an empowered group on coronavirus vaccination.
“Bharat Biotech must address the matter immediately through DCGI [Drugs Controller General of India] and WHO and avoid any situation that may lead to cancellation of WHO’s [emergency use listing] for Covaxin in future,” the foreign secretary said, according to PTI.
On April 2, the World Health Organization had said it has decided to suspend the supply of Covaxin through UN agencies to allow Bharat Biotech to address shortcomings in manufacturing practices that were found during an inspection.
However, the WHO had added that the vaccine was safe and effective, and that there was no “change in the risk-benefit ratio”. The global health body had recommended that countries that have received supplies of Covaxin should “take actions as appropriate”, but did not specify what these actions were to be.
Shringla, in his letter to Paul, said that this situation “further complicates the acceptance of Covaxin-based Indian vaccination certificates by other countries, especially by European Union member states such as Germany and France”.
The foreign secretary noted that some countries require international travellers to have taken m-RNA based vaccines, which negate India’s efforts to get recognition for Covaxin and Oxford-AstraZeneca’s Covid-19 vaccine Covishield.
On Friday, unidentified government officials told The Times of India that the communication by Shringla only listed out matter in a factual manner for the empowered group’s consideration, and did not reflect the position of the Ministry of External Affairs.
“Selective parts of the communication have been highlighted out of context to portray an incorrect picture,” the officials said.
On April 1, Bharat Biotech had said that it was temporarily slowing down the production of Covaxin, and would focus on pending maintenance and optimisation activities at its facilities. The vaccine maker said that it took the decision after having completed its supply obligations to procurement agencies.
Covaxin has been used in India since the immunisation drive started on January 16 last year. The vaccine received the World Health Organization’s emergency use approval on November 3.
Phase 3 trial results published by Bharat Biotech in November showed that the two-dose regimen of the vaccine had an overall efficacy of 77.8% in symptomatic Covid-19 patients.