News Analysis India

Tag: Covaxin production

  • Indian Immunological Limited to start Covaxin production by September, says govt

    By Express News Service
    NEW DELHI: Hyderabad based public sector undertaking Indian Immunological Limited may start supplying 2 million doses of Covaxin—country’s first and only fully indigenously developed Covid-19 vaccine so far by September, government authorities said on Tuesday.

    In a press briefing by the Union health ministry on Covid-19 status in the country, V K Paul, head of the national Covid-19 task force said that the two other undertakings with which the government has tied up with Covaxin production will take some time to start manufacturing.

    These PSUs include BIBCOL under the ministry and Haffkine Institute under the Maharashtra government.

    He however added that Bharat Biotech’s Ankleshwar facility could add another 6 million Covaxin doses in days to come. “Covaxin production capacity will increase. We expect a quantum jump after the Bangalore facility (of Bharat Biotech) starts,” said Paul in response to a query.

    He added that there has been a delay because of standardization issues, quality, efficient flow and validation. “This needed extra work, so there was a small delay. Some hiccups can occur. But an additional facility in Ankaleshwar has started — we’ll get 6 million doses. The PSUs — to an extent, from IIL, we’ll get 2 million doses by later August or September. “

    Paul added that at Haffkine and BIBCOL, substantial infrastructure is needed,  and they will take time to get operational. “We might need to wait until November-December for activation of those PSUs.”

    Earlier in the day, health minister Mansukh Mandaviya informed the Parliament that the monthly production capacity of Covaxin is expected to increase to around 58 million doses by December.

    “As communicated by the manufacturers, the monthly vaccine production capacity of Covishield is projected to be increased from 110 million doses per month to more than 120 million doses per month, and the production capacity of Covaxin is projected to be increased from 25 million doses per month to around 58 million doses per month,” the minister said in a written reply in the Rajya Sabha.

    The low supply of Covaxin has remained a concern despite claims by the government earlier that nearly 10 crore doses of this vaccine may be produced from September, which will help it meet the target of vaccinating all the adult population by 2021.

    In response to yet another query in the Parliament earlier, the government had informed that less than 5.5 crore doses of Covaxin, has been supplied for India’s Covid vaccination programme till mid-July showing that on average, the country may have received less than 1 crore doses per month of the vaccine so far.

  • Bharat Biotech ropes in subsidiary to scale up Covaxin production, estimates nearly 1 billion doses per annum

    By Express News Service
    NEW DELHI: Bharat Biotech on Thursday announced its plan to rope in its wholly owned subsidiary Chiron Behring for speed up production of Covaxin, India’s first and only indigenously developed COVID-19 vaccine so far, by an additional 20 crore doses per year.

    This will effectively take the volumes of Covaxin to nearly 1 billion doses per annum, produced at the company’s own established campuses specialised for manufacturing inactivated viral vaccines under the highest levels of biosafety, claimed the firm.

    As of now, Bharat Biotech is manufacturing only about 1.5 crore doses of Covaxin per month which is likely to go up to 4-5 crore doses per month by July this year.

    The company, facilitated by the Union government which is under huge pressure to fulfil huge demands for Covid vaccines in the country, has tied up with three public service undertakings to scale up the production of Covaxin.

    These undertakings, however, could take quite a few months before actual productions start.

    Bharat Biotech said on Thursday that Covaxin produced at Chiron Behring at Ankleshwar, Gujarat could be available September onwards.

    “Bharat Biotech had already deployed multiple production lines at its Hyderabad and Bengaluru campuses, adding Chiron Behring to this line up of high containment BSL (bio safety lab) rated GMP facilities that are required to manufacture Covaxin,” said the company in a statement.

    “The company plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety,” it said.

    “This effectively takes the volumes up to 1 billion doses per annum, with its own established campuses specialised for manufacturing inactivated viral vaccines under the highest levels of biosafety,” it added.

    The Ankleshwar-based plant would start rolling out the much in demand vaccine from the fourth quarter of the year, it added.

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    The company said it has already deployed multiple production lines for the vaccine at its Hyderabad and Bengaluru campuses.

    Government had earlier said that talks are on with at least nine other companies in other countries-including 5 in Germany—to scale up the production of Covaxin.

    Top authorities handling the Covid crisis in India, about a week back, had said that 2.16 billion doses of  vaccines could be available between August-December of which Covaxin will comprise 55 crore doses.

    However, experts have dismissed these projections as highly unrealistic.

    Chiron Behring Vaccines, a 100 per cent subsidiary of Bharat Biotech, is one of the largest manufacturers of rabies vaccines in the world.

    Last month, Bharat Biotech had announced that it has been able to enhance the production capacity of Covaxin to 700 million doses per annum.

    Manufacturing scale up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bangalore, the company had stated.

    Bharat Biotech sells Covaxin to the states at Rs 400 per dose.

    Facing the world’s fastest-growing coronavirus outbreak, India has seen a near collapse of its health care system in several parts as hospitals ran out of oxygen and did not have enough beds to admit new patients.

    To deal with the crisis, the government has, among other measures, opened up vaccination for all above 18 years.

    But the procurement of vaccines for those between 18 and 44 years has been left to states and private hospitals.

    This has led to state after state rushing to Bharat Biotech and Serum Institute of India (SII).

    Both the companies are at the forefront of supplying COVID-19 vaccines in the country even as the second wave of the pandemic continues to ravage various states.

    India has announced expansion of its COVID-19 vaccination drive by allowing its large 18-plus population to get inoculated from May 1.

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    Over the last few days several states have pointed out a shortage in supply of vaccines.

    Some of the states have even gone ahead by floating global tenders to cater to the demand.

    Bharat Biotech has received Emergency Use Authorisations (EUAs) for Covaxin in India and in several countries across the globe with another 60 in the process.

    Pricing for international markets and supplies to governments under EUA’s have been established between USD 15-20 per dose.

    (With PTI Inputs)

  • Bharat Biotech ramps up Covaxin production capacity to 700 million doses per annum

    By PTI
    NEW DELHI: To support vaccination campaigns in India and across the globe, Bharat Biotech has ramped up the manufacturing capacity of its COVID-19 vaccine, Covaxin, to 700 million doses per annum, the vaccine maker said on Tuesday.

    The company said in a statement that manufacturing scale up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bangalore. Sources said that the company had a production capacity of 200 million doses of Covaxin in the beginning.

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    Meanwhile, the chairman and managing director of Bharat Biotech, Krishna Ella, during an event said that the company will produce 30 million doses of Covaxin next month against around 20 million doses this month and 15 million in the last month. “Last month we produced 15 million doses, this month we are reaching 20 million doses, next month we will be making around 30 million doses followed by 70 to 75 million doses,” Ella said.

    He said that the company expects to reach a production capacity of up to 800 million doses per annum by July-August. “We are ramping up the production and by July-August we will be able to reach 700 to 800 million doses production capacity per annum,” Ella said.

    The company mentioned that inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines. “The company is able to expand Covaxin manufacturing capacity in a short timeline, mainly due to the availability of new specially designed BSL- 3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know how to manufacture, test and release highly purified inactivated viral vaccines,” Bharat Biotech said.

    Manufacturing partnerships are being explored with partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment, it added.

    The Hyderabad-based firm said it has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment, it added.

    The company said it uses a proprietary adjuvant Algel-IMDG, that has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses. The synthesis and manufacture of the IMDG component has been successfully indigenised and will be manufactured at commercial scale within the country. “This is the first instance where a novel adjuvant has been commercialised in India,” Bharat Biotech said.

    It added that Covaxin has received Emergency Use Authorizations (EUAs) for COVID-19 treatment in India and in several countries across the globe with another 60 in the process. EUA’s have now been obtained from Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries.

    The company said that EUA’s are in process in the US and several European countries. Pricing for international markets and supplies to governments under EUA’s have been established between USD 15-20 per dose, it added.

    Highlighting the need for vaccination, Ella said that injectable vaccines only protect the lower lung not the upper lung so many people may still get the disease after vaccination but it won’t be lethal and one gets protection against the seriousness of the disease. Wearing a mask is a must even after vaccination.