While Lupin is working on a Remdesivir powder for inhalation, Glenmark has tied up with a Canadian Biotech firm for nitric oxide nasal spray that reduces Sars-CoV-2 viral load and thus transmission.
"The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the consent form said.
The foreign envoys were taken to Hyderabad over a month after the ministry of external affairs briefed over 190 heads of diplomatic missions and representatives of leading international organisations on COVID-19 related issues.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
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.
'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'
The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
'I would go for Bharat Biotech's Covaxin and not Covishield, and that is my personal judgment since at least 11,500 have got at least one dose by now and it has proven to be safe.'
'he Centre has not issued any mandate, the stand of centre is that it should be 100 per cent but it is not a mandate'
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively.
Covishield comprises over 90 pc of 12.76 cr COVID vaccines administered so far
A bench of Justices L Nageswara Rao and B R Gavai said bodily autonomy and integrity are protected under Article 21 of the Constitution.
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
Out of the 45 lakh doses, the Hyderabad-based vaccine maker will be supplying over eight lakh to some of the friendly countries such as Mauritius, Philippines and Myanmar, free of cost as good will gesture sources added.
A nasal vaccine, one expert said, is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable.
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
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.
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
Covaxin, a whole-virion inactivated SARS-CoV-2 vaccine used for mass immunization in the country, showed a 65.2 per cent protection against the Delta variant in a double-blind, randomized, multicentre, phase 3 clinical trial.
The primary objective was to get the adult vaccine as children rarely have a severe form of the disease. Once schools reopen, the demand for vaccines for children under 12 may soar.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
As the United States focuses on the Indo-Pacific, in particular the Quad, the Biden administration needs to address India's ties with Russia and its 'downward trend of democratic values and institutions', said a report by the Democratic Party of the Senate Foreign Affairs Committee.
The Kraken COVID-19 variant accounts for almost 41 per cent of all Covid infections.
In a statement Bharat Biotech clarified that the vaccine's efficacy can only be determined 14 days after the second dose.
Apart from the 1.1 crore doses of Covishield being procured from the Serum Institute of India, 55 lakh doses of indigenously developed Covaxin were being obtained from Bharat Biotech, Union Health Secretary Rajesh Bhushan said at a press conference.
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 US has invoked the Defence Act and banned export of raw materials.' 'This is as good as banning vaccines.'
"I appeal to all those who are eligible to take the vaccine. Together, let us make India COVID-19 free!" Modi said.
The NTAGI has not yet suggested any change in the schedule of Bharat Biotech's Covaxin.
Experts, however, feel that given the intensity of the second wave and the high single dose coverage, India is in a good position to avoid any drastic wave in the near future.
Dominic Xavier salutes every single person involved in making this miracle possible.
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".
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
The production of Covaxin will increase from the current 10 million doses per month to 60 million-70 million by July-August.
Apollo Hospitals and Fortis Healthcare are open to importing vaccines.
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