"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.
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.
This apart, to further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the 'capabilities and expertise' to manufacture the inactivated viral vaccines at commercial scale.
'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 vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
Justice Rekha Palli issued notice to the Delhi government and sought its stand on whether it can provide the second dose of Covaxin to those who got the first jab, before expiry of the incubation period of six weeks between the two doses.
Adjuvants may be added to a vaccine to produce more antibodies and longer lasting immunity thus minimising the dose of antigen needed.
The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results.
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.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
'Antibodies remain in the blood for at least seven to nine months.'
Bharat Biotech is also looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin, he added.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
Covaxin is being developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research - National Institute of Virology.
After having received the government purchase order for 55 lakh doses, Bharat Biotech shipped the first batch of vaccines (each vial containing 20 doses) to Gannavaram (Vijayawada), Guwahati, Patna, Delhi, Kurukshetra, Bangalore, Pune, Bhubaneswar, Jaipur, Chennai and Lucknow.
The vaccine was well tolerated in all dose groups with no vaccine-related adverse events.
Tope said only 35,000 vials of Covaxin are currently available with the state government for administering the second dose to the people above 45 years.
The hospital authorities informed the Jaipur chief medical and health officer about the theft on Tuesday night following which an FIR was lodged on Wednesday.
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.
Last week, Estado de Sao Paulo newspaper reported that the government signed a deal for 20 million vaccine doses, $15 each. However, according to a secret message from the Brazilian embassy in New Delhi, the actual price for one dose was Rs 100 ($1.34).
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
'In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible'
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.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
These vaccines have not yet been approved by the World Health Organization
There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group," Swaminathan said.
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.
Categorically denying the charge, he slammed the BJP spokesperson Sambit Patra's claim that Punjab, along with other Opposition-ruled states, had expressed doubts and refused to accept the vaccination.
The vaccine induced robust binding and neutralising antibody responses which were comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19, according to the findings which have appeared on medRxiv, a preprint server.
It would be a trial on children aged 2-18 years for which Bharath Biotech may get the licence in the third quarter of this year.
There are 12 sites across India, including private and public hospitals, conducting Phase 1 and 2 human clinical trials for Bharat Biotech's Covaxin. Based on an earlier letter by the Indian Council of Medical Research (ICMR) to the 12 sites, volunteer recruitments for the clinical trials were to begin by July 7. At least three sites are yet to kick-start the process.
Prime Minister Narendra Modi took second dose of COVID-19 vaccine at the AIIMS in New Delhi, and asked those eligible for the shot to take it soon to defeat the virus.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.
'Seek medical help if after five days of the first symptom the fever has not subsided.'
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
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