'Once DCGI will give us the permission to restart the trials in India, we will resume the trials,' Serum Institute of India (SII) said in a statement.
Tope also informed that the Centre has asked the state to reduce the number of inoculation centers from 511 to 350, saying the government should focus on other emergencies also.
Covishield vaccine production won't be hit due to the fire, Serum Institute of India Chief Executive Officer Adar Poonawalla said. The Manjari facility is where the Covishield vaccine used in the nationwide inoculation drive against the pandemic is made.
Apart from making efforts to meet the requirements of India, the company is also trying its best to balance the needs of the rest of the world, he added.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
SII executive director Suresh Jadhav on Friday alleged that the government began inoculating people from multiple age groups without taking into account the available stock of vaccines and the WHO guidelines.
The Centre on Wednesday placed a second purchase order with the Serum Institute of India for the supply of one crore doses of Oxford-AstraZeneca COVID-19 vaccine 'Covishield', each costing Rs 210, including GST, sources said.
Billionaire Mukesh Ambani's Reliance Industries Ltd is the most valuable private company in the country, as per Hurun India's 2022 Burgundy Private Hurun India 500 list. The list, which was released on Tuesday, stated that with a value of Rs 16.4 lakh crore, Reliance is India's most valuable company, followed by Tata Consultancy Services (TCS) with Rs 11.8 lakh crore and HDFC Bank with Rs 9.4 lakh crore. Reliance is also the highest taxpayer with a payout of Rs 16,297 crore and the most profitable company with a bottomline of Rs 67,845 crore in 2022-23.
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.
Heads of fire departments of the Pune Municipal Corporation (PMC), Pune Metropolitan Region Development Authority (PMRDA) and Maharashtra Industrial Development Corporation (MIDC) are part of the joint probe team.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
SII has so far provided more than 170 crore doses of Covishield to the government for the national immunisation programme.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
Representatives from seven vaccine makers -- Serum Institute of India, Bharat Biotech, Dr Reddy's Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech -- will be participating in the meeting.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
Dominic Xavier salutes every single person involved in making this miracle possible.
Dispatch of the vaccine is likely to start by early Tuesday morning, sources said. According to the order placed, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
Several states and UTs including Delhi, Maharashtra, Karnataka and Telangana have decided to opt for global tenders for procurement of anti-coronavirus shots with the domestic supply falling short to meet the rising demand.
The parties intend to produce over 300 million doses of the vaccine in India per year.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
A Chennai-based man has demanded a compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine.
A source closely involved in logistical arrangements said the movement of vaccine doses is likely to start from early Tuesday morning through road and air routes amid elaborate police security.
The Bombay high court on Monday said content posted by two individuals and their organisations against vaccine manufacturing major Serum Institute of India (SII) was "prima facie defamatory" and directed them to delete it.
The prime minister was happy that the assurance given by the Serum Institute that it will make India self-sufficient in vaccines at the lowest possible price in the world was fulfilled.
This year, eight eminent individuals are being given Padma Bhushan and 54 are being conferred with Padma Shri awards, besides the two Padma Vibhushan recipents.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
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.
The study also noted that the booster dosage of the company's COVID-19 vaccine Vaxzevria also increased the immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2 variants.
A bench of Justices L Nageswara Rao and B R Gavai said bodily autonomy and integrity are protected under Article 21 of the Constitution.
Earlier this month, India had said that all British nationals arriving in India from the UK will have to undergo a mandatory 10-day quarantine if they are fully vaccinated against COVID-19.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said vaccine effectiveness will be seen only after 14 days.
In a recent letter to Union Home Minister Amit Shah, SII said its employees have been working round the clock in spite of various challenges because of the pandemic.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Five labourers had died in the fire that broke out in a five-storey building in the SII's Manjari premises in Pune on January 21.
Poonawalla said booster vaccines have no demand as there is general lethargy among people and also because they are fed up with the pandemic.
Microsoft Chairman and CEO Satya Nadella along with Alphabet Inc and its subsidiary Google CEO Sundararajan Pichai are also among those from trade and industry who have been awarded the Padma Bhushan for their distinguished services.
"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.
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