News Analysis India

Tag: vaccine 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.

  • 216 crore Covid vaccine doses projected between August and December was ‘aspirational’: Centre

    Express News Service
    NEW DELHI: Conceding that the projection of 216 crore Covid vaccine doses between August and December this year was “aspirational”, the government on Friday conceded that the figure revised to 135 crore doses in the Supreme Court may be more realistic. 

    In a press conference on Covid status in the country by the Union ministry of health and family welfare, senior authorities said that these projections should be seen in the “right context”. 

    In May, the government had projected 216 crore Covid19 vaccine doses for India in the last five months this year but in a submission before the apex court on June 26, the target figure was lowered to 135 crore. 

    “The earlier estimate of 216 crore vaccine doses between August and December 2021 was an aspirational or optimistic one, “said VK Paul, member (health), Niti Aayog and chairman of the National Expert Group on Vaccine Administration for Covid. 

    “The figures should be seen in the right context as this is a dynamic situation.” 

    Paul further added that when the government proposed the estimate of 216 crore vaccines between August and December this year, it had collated the figures provided by vaccine makers, through their “responsible, optimistic and aspirational roadmap.” 

    ALSO READ | Now, pregnant women too can take Covid vaccine, says Centre

    “The private sector is very influential in India; they have such a major contribution to the GDP. They are reputed vaccine-maker conglomerates. We collated what they showed,” he said. 

    The official added that in its earlier estimate of 216 crore vaccine doses, the government had taken into account the future availability of Biological E, Zydus Cadila’s DNA vaccine, Novavax and Bharat Biotech’s nasal vaccines. 

    “But as far as the main vaccine makers – Serum Institute of India and Bharat Biotech — are concerned, at present 90 crore vaccine doses are estimated from each and this can also go up,” he said. 

    As per the affidavit filed in the court, the Centre has now projected availability of 50 crore doses of Covishield and 40 crore doses of Covaxin between August-December. In addition, 30 crore doses of vaccine by Bio E, 10 crore doses of Sputnik V and 5 crore doses of vaccine by Zydus Cadila are also slated to be available. 

    The government also claimed that the vaccination drive will get a further boost if it succeeds in its attempts to procure vaccines available outside India such as vaccines of Pfizer, Johnson & Johnson, Moderna. 

    “It is submitted that for the purpose of procurement of these vaccines from abroad, efforts are ongoing at the level of the highest political executive in the country and also at the highest diplomatic level,” read the affidavit.

    The Centre had maintained that since these efforts are at a very advanced stage, it is not possible to give comprehensive details but as and when these efforts materialise, “the speed of vaccination will be further augmented and enhanced”.

  • Number of Covid vaccine doses shown as available by Centre not matching up with supply

    Express News Service
    NEW DELHI: A huge 2 crore gap between total Covid vaccines available and actual inoculations in May has prompted experts to raise doubts over Centre’s assertion of 12 crore doses being available in June, saying it could only be the projected production capacity and not doses available for vaccination. 

    In May, 7,94,05,200 doses of Covid were shown as available through the central supply and the direct procurement by states and private hospitals but the doses administered in the month were just about 6.10 crore.

    For June, the government has said that 11.95 crore doses — 6.1 crore through central quota and 5.9 crore for direct purchase by states and hospitals — will be available for procurement and supply. 

    The margin seen in the doses shown as available and vaccinations in May, however, were explained by the Union Health Ministry, in a press briefing on Tuesday as either balanced doses with states for administration or “in the supply pipeline”.

    In a statement issued on Wednesday the government reiterated that while 6.1 crore vaccine doses were administered in May, 1.62 crore balance and unutilized doses were available with states.

    Experts, however, say that the numbers, despite this argument, do not add up.

    Economist R Ramakumar pointed out that while India’s production capacity for Covid vaccines, submitted by the Centre in a Supreme Court affidavit last month, may have been 8.5 crore, 6.5 crore for Covishield and 2 crore for Covaxin in May, looks like the country did nor manufacture those many vaccines.

    To support his argument, Ramakumar proposes that globally Covid vaccine makers making adenovirus based vaccines, just as Covishield, are seriously hampered by “yield instability”.

    ALSO READ | Sound-based diagnostic test for Covid shows 93% accuracy: IISc scientists

    What this means is that large tanks are used to grow mammalian cells for about 2 months which then allows the virus to replicate in these cells for a few days and producers have a prior estimate of this replication rate.

    “These prior estimates would be true only if cells divide and grow as expected. But they may not,” says Ramakumar, adding that a range of variations can exist in production conditions, which make biological production fundamentally different from industrial production.

    He therefore says that reasons like this one may be delaying production and any projection on what doses are available may be just “writing on water”.

    On the “balance dose” clarification, Ramakumar pointed out that at the end of April, the Centre had shown around 1 crore doses as balance which may have been administered in May.

    Health economist Rijo M John too told The New Indian Express that 8 crores available for May is based on an assumed production capacity.

    “I don’t think 12 crore doses would be available for June as the government says because the indicative production capacity for the Serum Institute of India and Bharat Biotech combined is only 8.5 crore,” he said.

    Even if those capacities were to materialize fully, which is quite unlikely, John added, given what happened in May, the actual inoculations for the month of June would be much less and can’t be significantly different from that in May.

    Economist Pritam Datta of the National Institute of Public Finance and Policy, reckoned that low vaccinations in May have also been due to less vaccine procurement by states, possibly due to fund crunch.

    “I think June onwards the process will be much smoother, as state governments are now better equipped or prepared to cater this need”.

  • 3.11 crore doses of Covaxin procured so far, 90 lakh doses expected in June: Centre

    Express News Service
    NEW DELHI: On a day Bharat Biotech said that the production cycle of Covaxin is 120 days, the Centre too issued a clarification saying that the company is supplying over 3.11 crore vaccine doses by May while 90 lakh additional doses are expected next month.

    It said that the current production capacity of Covaxin, which is 1 crore per month, will be doubled by May-June and then increased nearly 6-7 fold by July – August. It is expected to reach nearly 10 crore doses per month by September this year, the Union Health Ministry claimed in a statement.

    “Vaccine being a biological product of medical importance takes time for harvesting and quality testing,” said the government. “This cannot be done overnight to ensure a safe product.” 

    ALSO READ | ‘Covaxin has a production cycle of 120 days’: Bharat Biotech on delayed availability of vaccine

    Thus, an increase in capacity of manufacturing too needs to be a guided process and an increase in gross production does not translate to immediate supply, the Centre maintained.

    Till Friday morning, as per the data shared, Bharat Biotech has supplied 2,76,66,860 vaccine doses to the Centre. Out of these, 2,20,89,880 doses including wastage, have been consumed by all states in the ongoing vaccination drive.

    With this, the balance of available doses of vaccine with states are 55,76,980 doses while private hospitals have also received 13,65,760 doses of Covaxin in the same month over and above what has been supplied to the governments at the Centre and the states, said the ministry.

    In May, additional 21,54,440 doses of Covaxin are to be supplied. “This takes the total vaccine supplied and in pipeline till date to 3,11,87,060 doses,” the statement said, adding that nearly 90 lakh doses are committed for June by the manufacturer.

  • Centre’s 2 billion vaccines dream: Can happen only if daily production rises six-fold, say experts

    Express News Service
    NEW DELHI: A day after Centre’s pledge that over 2 billion doses of Covid vaccines will be available in India during the last five months this year, experts expressed scepticism over the projected numbers saying they look “impractical”, if not “impossible”.

    The country as of now produces just 2.3 million doses of Covid vaccine daily, but the figures projected by the government suggest that this will rise by 6-fold between August-December.

    In a press briefing on Thursday, V K Paul, member, Niti Aayog, who also heads the National Covid task force said that 2.16 billion doses of Covid vaccines are set to be available in the country between August-December, enough to cover nearly 95 crore of India’s adult population.

    The projected doses include 75 crore doses of Covishield, 55 crore doses of Covaxin and 15.6 crore doses of Sputnik V whose local production will begin from July. 

    The estimates also included 30 crore doses of Covid vaccine by BioE, 5 crore doses of Zydus Cadila vaccine, 20 crore doses of vaccine by Serum Institute of India-Novavax, 10 crore doses of Bharat Biotech-Washington University’s nasal vaccine and 6 crore doses of Gennova vaccine—all of which are still under various phases of clinical trials.

    Those who have tracked Covid vaccine developments over the years, however, have a major concern — how can the production be ramped up so quickly?

    “It is a very ambitious target and I would be happily surprised if that’s achieved—but I am now sure how that is going to happen,” said microbiologist and immunologist Sudhanshu Vrati.

    According to R Ramakumar, an economist with Tata Institute of Social Sciences, as per the projections, SII will have to raise the production of Covishield to nearly 3 times per day to meet the target.  

    ALSO READ | Centre says open to facilitate Covaxin tech transfer to ramp up production

    “SII is already struggling to meet the promise of 3.3 million doses of Covishield per day by July. How are they going to make 6.4 million doses per day by December?,” he asked.

    To meet the target of 55 crore doses of Covaxin in 5 months, its 3.7 million doses will have to be produced per day, Ramakumar also pointed out, adding that how is that possible given that the three undertakings that the government has tied up with for its production, will not start producing before 8-12 months.

    Vrati said, given that the undertakings roped in include BIBCOL, a firm which has no experience of vaccine manufacturing, it may take 36, not 6 months, before it can start shelling out the vaccine.

    ALSO WATCH: India’s COVID situation hugely concerning, says WHO | Expert Talk​

    “Even if the work starts on war footing now to create biosafety level 3 labs in these companies, required for Covaxin production, it may take at least 6 months for the vaccine batches to roll out from these plants,” he said.

    But it’s not only the experts who are raising doubts. The Union government, in an affidavit to the Supreme Court last week, had said that Covaxin production per day will rise from 0.3 million doses to 3.3 million “in the next 8-10 months”.

    And it’s not only these two vaccines whose capacity escalation appear to be difficult, most others — projected to be available in abundance — are yet to even prove their efficacy.

    “These vaccine candidates first need to show trial results and get regulatory approvals based on evidence,” said K Srinath Reddy, president of the Public Health Foundation of India. 

    On being asked whether the promise of enough vaccines for all by year end looks feasible, Reddy added: “The government must have had a discussion with manufacturers before coming up with the projections, so we will have to wait and see.”

  • COVID -19: Parliamentary panel had asked govt in March to ramp up vaccine production capacity

    By PTI
    NEW DELHI: A parliamentary standing committee had in March suggested ramping up of production capacity of the two COVID vaccines manufactured in India for ensuring their availability to a wider population as soon as possible after it was informed that there could be a “shortage” if the inoculation is opened beyond the priority groups.

    The recommendation was made by the 31-member committee on Science and Technology, Environment, Forests and Climate Change, chaired by senior Congress leader Jairam Ramesh, in its report on Demand for Grants for Department of Biotechnology that was tabled in Parliament on March 8.

    The panel has as many as 14 members from the ruling BJP.

    “The Committee recommends to strengthen the efforts for ramping up the production capacity of the two approved vaccines as well as provide all research, laboratory infrastructure and capacity building support to the other vaccine candidates in the pipeline, in order to ensure the availability of a safe, affordable, and efficacious vaccine to the wider population as soon as possible,” the report said.

    According to sources, during the standing committee meeting on February 17, members of the panel had asked as to how soon the vaccination exercise can be opened beyond priority groups, to which it was conveyed that there could be a shortage if it is opened beyond the priority groups.

    When asked about the recommendation of the committee, Ramesh said it was clear to the panel from the submissions made by the government that the current production would be inadequate to meet the demand for vaccines.

    “India needs around 1.9 billion doses to fully vaccinate all adults. It was clear to the Standing Committee from the data presented by the government that the current production capacity is inadequate to meet that demand.

    “That’s why we recommended that the production capacity must be ramped up as soon as possible. Alas, this wasn’t done, and now we are facing a massive vaccine shortage,” the house panel chairman Jairam Ramesh told PTI.

    However, BJP MP from Jhansi Anurag Sharma, who was part of the panel, said the Centre had worked on the committee’s recommendations by allocating funds to both Bharat Biotech and Serum Institute of India.

    Several states have decided to issue global tenders for procurement of COVID vaccines as the domestic supply has failed to keep up with the rising demand amid the fierce second wave of the pandemic.

    These include Uttar Pradesh, Maharashtra, Delhi, Karnataka, Andhra Pradesh, Telangana and Odisha.

    The parliamentary panel report tabled in March also mentions that Covaxin, developed jointly by Bharat Biotech and the Indian Council of Medical Research (ICMR), has a planned production capacity of 150 million doses per year.

    The estimated manufacturing capacity of Covishield manufactured by the Serum Institute of India is about 70-100 million doses per month.

    The Department of Biotechnology had also informed the standing committee that the Centre launched ‘Mission COVID Suraksha’ for research and development of Indian COVID-19 vaccines which are affordable and accessible.

    The mission aims to accelerate the development of approximately 5-6 vaccine candidates.

    It is being implemented by BIRAC, a PSU.

    The total budget allocated to it is Rs 900 crore for 12 months.

    India started the world’s largest vaccination drive on January 16 this year in a phased manner with healthcare workers (HCWs) getting inoculated first.

    The vaccination of frontline workers (FLWs) started from February 2.

    The next phase of COVID-19 vaccination commenced from March 1 for those over 60 years of age and for people aged 45 and above with specified co-morbid conditions.

    India launched vaccination for all people aged more than 45 from April 1.

    Implementation of the Liberalised and Accelerated Phase 3 Strategy of Covid-19 Vaccination to inoculate those in the age group of 18-44 years started from May 1 amid the outbreak of the second COVID wave.

    The Centre had also allowed states to directly procure vaccines from manufacturers at a pre-decided rate.