Amid reports of government’s assurance of indemnity to foreign vaccine manufacturers, Pfizer and Moderna, Pune-based Serum Institute has also sought protection against legal action in India, news agency ANI reported citing sources familiar with the matter. All vaccine makers, whether Indian or foreign, should be granted the same protection, the pharma company has reportedly told the government.
“Not just SII, all vaccine companies should get indemnity protection against liabilities if foreign companies are granted emergency use authorisation,” the vaccine maker was quoted as saying by the news agency.
The Serum Institute produces Covishield – the Indian name for Oxford-AstraZeneca’s shot – and is involved in trials for three new anti-Covid vaccines.
Earlier on Wednesday, Adar Poonawalla, CEO, SII, had said that vaccine manufacturers need to have protection against all lawsuits for their vaccines especially during a pandemic.
Earlier, it was reported that the Centre may grant legal protection from liability to Pfizer and Moderna in order to expedite the approval process for anti-covid vaccines in India, news agency ANI reported.
The decision came in backdrop of pharma giants seeking government indemnity from costs relating to severe vaccine side-effects. The move will clear way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement.
Also Read: Covid-19 Vaccine: Centre may grant protection against legal action to Pfizer, Moderna
Pfizer, which is ready to offer 5 crore doses to India between July and October, had stressed on indemnity, sharing efficacy trials and approvals for its vaccine in various countries and by WHO. Although Pfizer has obtained legal protection in several countries, including Britain and the United States, India has not given any manufacturer of a Covid-19 vaccine indemnity against the costs of compensation for any severe side effects.
In another key waiver, the drug regulator has done away with the requirement of India-specific trials for foreign vaccines approved by specific countries and WHO for emergency use.
In a letter, DCGI Chief VG Somani letter said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
