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.
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.
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.
'You can still acquire the COVID-19 virus even if you are vaccinated.' 'But if you develop the disease, (after being vaccinated) the likelihood is that it will be mild.' 'It just makes sense to continue to take precautions, because you may be around a lot of unvaccinated people.'
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.
Raches Ella, project lead, Covid-19 vaccines at Bharat Biotech said in a series of tweets that he was 'surprised' that media and researchers were drawing conclusions based on non-peer reviewed work.
Vaccines Covishield and Covaxin work against SARS-CoV-2 variants Alpha, Beta, Gamma and Delta, while effectiveness tests against the Delta Plus variant is ongoing, the government said.
"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.
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.
They said 37.5 crore of Covishield doses from the Serum Institute of India and 28.5 crore Covaxin doses from Bharat Biotech will be procured by December.
Chief Medical Officer Sandip Chaudhary on Wednesday said he has ordered an inquiry into the matter and assured stern action against those found responsible for this negligence.
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.
An expert panel of the Central Drugs Standard Control Organisation on July 29 had recommended granting permission for conducting the study.
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.
'The residents are a bit apprehensive about the lack of complete trial in case of Covaxin and might not participate in huge numbers thus defeating the purpose of vaccination. We request you to vaccinate us with Covishield which has completed all stages of trial before its roll-out'
The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
The most important finding of the study was that the Spike-protein neutralising antibodies found in the mixed vaccine groups were significantly higher than the same-vaccine groups, D Nageshwar Reddy, Chairman of AIG Hospitals said.
'Antibodies remain in the blood for at least seven to nine months.'
The government on Tuesday set the maximum price private hospitals can charge for the three COVID-19 vaccines currently available in the country -- Covishield Rs 780 per dose, Covaxin Rs 1,410 and Sputnik V Rs 1,145.
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.
Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
Neutralising antibody levels waned after six months in those who were fully vaccinated against the coronavirus with Covishield, Covaxin and a mix of both.
Delhi currently has four days of Covaxin and three days of Covishield stock for those above 45, and healthcare and frontline workers.
Covishield comprises over 90 pc of 12.76 cr COVID vaccines administered so far
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.
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.
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
500 million doses per annum from its two sites in Hyderabad and 200 million doses each from its Ankleshwar and Kolar facilities.
The NTAGI has not yet suggested any change in the schedule of Bharat Biotech's Covaxin.
An association of government doctors in Karnataka has demanded that health care workers be allowed their choice of the COVID-19 vaccine, saying there have been some concerns among a section of the fraternity over the present arrangement for making available the doses.
Bharat Biotech said that it is disheartening to listen to some states complaining about company's intentions regarding supply of COVID vaccine Covaxin.
Several citizens expressed anger and frustration at the state of affairs as many of them are due for their second dose since they had taken the first jab over 42 days back.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
A technical advisory group of the World Health Organisation was on Tuesday reviewing data on Covaxin for the emergency use listing of India's indigenously-made vaccine and it could pronounce its decision within the next 24 hours or so, a spokesperson said.
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".
The move follows the World Health Organisation's Emergency Use Listing for Covaxin, which is the second most used formulation in India.
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.
Sources close to the development said the company had no further supply commitments to the WHO, and therefore, there was no suspension of any upcoming orders, reports Sohini Das.
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