The Supreme Court questioned petitioners who challenged the accuracy of India's COVID-19 vaccine adverse effect data, suggesting they unduly trusted UK figures. The court heard arguments about alleged deaths due to the Covishield vaccine and reserved its order.
Karnataka Chief Minister Siddaramaiah alleged that the rushed approval and distribution of the COVID-19 vaccine may be a contributing factor to cardiac arrest deaths, citing several international studies that recently suggested a possible link between the vaccines and a rise in heart attacks.
The world is learning about a side effect of the COVID vaccine called Thrombosis with Thrombocytopenia Syndrome, he said.
United Kingdom-headquartered pharmaceutical giant AstraZeneca (AZ) has admitted that in 'very rare cases' its Covid vaccine can cause a blood clot related side effect but the causal link is unknown, according to court papers being quoted in the UK media.
'I understand some people are comfortable getting a Covishield shot as their third dose.'
The Supreme Court of India has advised a petitioner, who claims to have suffered disability due to the side effects of the first dose of a Covid-19 vaccine, to file a suit for damages instead of pursuing his plea before the court. The court suggested that filing a suit could provide quicker relief than waiting for a potentially lengthy decision on the petition.
Serum Institute of India (SII) CEO Adar Poonawalla on Wednesday said it has restarted manufacturing of Covid-19 vaccine Covishield amid rising numbers of cases of the virus infection.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
Poonawalla said booster vaccines have no demand as there is general lethargy among people and also because they are fed up with the pandemic.
If the vaccine is recommended for use as a booster against Omicron, it may significantly boost the demand for Covishield in India.
The quantity of Covid vaccines to be exported will be decided by the government every month to ensure there is no dearth of domestic availability.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
The economics and pricing of the Covishield vaccines and the government's own decision to pay higher prices raise more than a few questions, observes Prosenjit Datta.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
The NTAGI has not yet suggested any change in the schedule of Bharat Biotech's Covaxin.
This is for the first time that a booster dose that is different from the one used for primary vaccination against COVID has been allowed in the country.
An expert panel of the Central Drugs Standard Control Organisation on July 29 had recommended granting permission for conducting the study.
A number of Indian medical experts on Monday supported calls from an eminent British Indian cardiologist for a full safety review into the use of Oxford/AstraZeneca's Covid-19 vaccine, administered in India as Covishield, over feared serious side effects such as heart attack and stroke.
India has already asked the EU member countries to individually consider allowing Indians who have taken Covishield and Covaxin vaccines and want to travel to Europe.
The study by a group of doctors showed that after two shots of the vaccines, 98 per cent recipients of Covishield showed antibody response, while the same was 80 per cent among Covaxin recipients. Sohini Das and Ruchika Chitravanshi report.
SII has so far provided more than 170 crore doses of Covishield to the government for the national immunisation programme.
The study titled 'Serendipitous COVID-19 Vaccine-Mix in Uttar Pradesh, India: Safety and Immunogenicity Assessment of a Heterologous Regime' has been uploaded on medRxiv, a preprint server and is yet to be peer reviewed.
Prior to the beginning of the nationwide vaccination drive against Covid-19 in India on January 16, the Pune-based Serum Institute of India has issued a factsheet to answer frequently asked questions that vaccine beneficiaries might have.
The Union health ministry on Sunday clarified that already booked online appointments for second dose of Covishield vaccine will remain valid and the same will not be cancelled on Co-WIN platform.
'We're clear Covishield is not a problem. The UK is open to travel and we're already seeing a lot of people going from India to the UK, be it tourists, business people or students,' Alex Ellis, British high commissioner to India, said.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
Amid concerns over dangerous side-effects of the Oxford's COVID-19 vaccine, India is evaluating all serious adverse events post-vaccination to determine the causality aspects of Covishield and Covaxin, an expert associated with the process said on Saturday.
Dr Malhotra, who has demanded a full safety review into the use of AstraZeneca's Covid vaccine, told PTI Covishield "should never have been rolled out in the country in the first place".
"I realise that a lot of Indians who have taken Covishield are facing issues with travel to the EU, 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 said in a tweet.
"The vaccination schedule is considered complete 28 days after the administration of a dose for Janssen vaccine and 7 days after administration of a second dose for other vaccines (Pfizer / Comirnaty, Moderna, AstraZeneca/Vaxzevria/Covishield)," the statement added.
"We have requested EU member states to individually consider extending similar exemption to those persons who have taken COVID-19 vaccines in India, that is Covishield and Covaxin, and accept the vaccination certificate issued through the CoWIN portal," said a source.
Pharma giant AstraZeneca's Covid-19 vaccine is being withdrawn worldwide after the company acknowledged for the first time in court documents that it can cause a rare and dangerous side effect, according to a report in the British newspaper The Telegraph.
We have applied for marketing authorisation to the EMA through AstraZeneca. We will not sell the vaccine in the EU, said a company source.
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
This decision of revised time interval between two doses is applicable only to Covishield and not to Covaxin vaccine, the ministry said.
The Union health ministry on Wednesday dismissed media reports claiming there was dissent from technical experts about increasing the gap between two Covishield doses and said the decision was based on scientific reason about the behaviour of adenovector vaccines.
The development comes after Prakash Kumar Singh, the Director, Government and Regulatory Affairs at SII, informed the Union health ministry that the firm would be able to supply 20.29 crore doses of Covishied in the month of September.
Anurag Agrawal, the Director of the Institute of Genomics and Integrative Biology, said the study on effectiveness of the available vaccines on the B.1.617 variant of SARS-CoV2 suggests that post vaccination, the infections are milder.
Those who have recovered from COVID-19 respond faster to the Covishield vaccine and reach high antibody levels, says a study, leading to hopes that they may not need a second dose and therefore help widen India's corona immunisation cover.
The Serum Institute of India has informed the Centre that it will be able to supply around 22 crore doses of Covishield in October as the Union government has announced resuming export of surplus Covid vaccines in the coming fourth quarter under the 'Vaccine Maitri' programme, official sources said.
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