News Analysis India

Tag: Zydus Cadila

  • 51.6 crore vaccines would be available by 31st July, 35.6 crore already provided: Centre to SC

    By PTI
    NEW DELHI: The Centre Saturday told the Supreme Court that a total of 51.6 crore Covid vaccine doses would be made available by July 31 of which 35.6 crore have already been provided.

    Giving the status of vaccine availability for children, the Centre said in an affidavit that the Drugs Controller General of India on May 12 permitted Bharat Biotech to conduct clinical trials of its vaccine Covaxin on volunteers between 2 to 18 years of age, and the enrolment process for this trial has also begun.

    It informed the court that Zydus Cadila which is developing DNA vaccines has concluded its clinical trial for between the age group of 12 to 18 years of age and, subject to the statutory permissions, it may be available in near future for children of the age group of 12 to 18 years of age.

    “It is humbly submitted that as of now, the companies’ manufacturing COVID-19 vaccination in India have only been given ‘Emergency Use Authorization’ for vaccinating people of 18 years age and above.

    Therefore, COVID-19 vaccines are not recommended for persons/children less than 18 years of age and is due to the fact that the clinical trial cohort during Phase 1, 2 and 3 did not cover the children below 18 years of age,” it said.

    ALSO READ | Near home vaccination centres for elderly, differently abled set up: Centre tells SC

    The government said that there would be availability of vaccine to vaccinate the entire eligible population.

    It said the “biggest vaccination drive in the history” is going on with full swing, reaching even remotest areas of the country by constructive and cooperative collaboration of the Central government, State/UT governments, local authorities, human resources in medical sectors and the citizens of the country.

    Giving the break-up of vaccines till the date of filing of the affidavit i.e.June 26, the Centre said a total of 35.6 crore doses were made available — 26.6 crore Covishield, 8 crore Covaxin, and additional 1 crore doses as commodity assistance under COVAX facility.

    It also said that apart from these supplies, it is expected that around 16 crore doses will also be available during the period of May and July across the country.

    The Centre further said that 31.5 lakh doses of first component and 60,000 doses of second component of Sputnik V has been received.

    It said that two vaccines (Covishield and Covaxin) have been a part of the vaccination program since January 2021 and Sputnik V has received Emergency Use Authoridation by the DCGI in April 2021 and is now being administered in the country.

    ALSO READ | ‘Near home’ COVID vaccination centres will benefit 14 crore senior citizens: Centre

    The government said, “In addition, some other domestic vaccines such as those from Biological E and Zydus Cadila are in the late stages of clinical trials and subject to the regulatory approvals, will further increase the availability of vaccines.”

    The government in its 380-page affidavit filed in the suo motu matter on COVID-19 management said that in order to further increase vaccine availability and incentivising foreign manufacturers, the regulatory process for the use of foreign vaccines within India has been accelerated and simplified.

    It clarified that due to the initial assistance provided for developing Covaxin, it has ensured a price of Rs.150 per dose of Covaxin and it is not possible to reduce it any further.

    “This price is the lowest procurement price in the world.”

    The government said that as per the projected mid-year population for 2020, the total population of the country aged 18 years and above is approximately 93-94 crore and as such, administering two doses to these beneficiaries would require an estimated 186 to 188 crore vaccine doses.

    “Out of this requirement, 51.6 crore doses will be made available for administration by July 31, 2021, leaving a requirement of approximately 135 crore vaccine doses for complete vaccination to the eligible population,” it said.

    Giving the breakup for vaccines quantity that may be receivable from all sources the Centre said that a total of 135 crore doses will be procured: Covishield (50 crore), Covaxin (40 crore), Bio E Subunit vaccine (30 crore), Zydus Cadila DNA vaccine (5 crore) and Sputnik V (10 crore).

    It said that the procurement of Bio E Subunit vaccine and Zydus Cadila DNA vaccine will be subject to approval which will come in the near future.

    ALSO READ | Till June 25, more than 31 crore COVID-19 vaccine doses administered: Centre to SC

    “It is submitted that the vaccination drive would obviously get a boost if the Government of India succeeds in its attempts to procure vaccines available outside India such as vaccines of Pfizer, Johnson & Johnson, Moderna etc,” the affidavit said.

    The Centre said 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.

    “It is submitted that since these efforts are at a very advanced stage, it is neither desirable nor possible to give comprehensive details of these facts. As and when these efforts materialise, the speed of vaccination will be further augmented and enhanced,” it said.

  • India could get fourth Covid vaccine as Zydus Cadila set to seek nod for ZyCoV-D

    Express News Service
    NEW DELHI: Ahmedabad-based Zydus Cadila is set to apply for emergency use authorisation of its Covid vaccine candidate, still under the phase 3 efficacy trials, within next few days and it could soon be the fourth available vaccine against coronavirus in India.

    If the regulatory approvals come through, the vaccine, being called ZyCoV-D now, will be the first DNA vaccine, licensed for use in humans.

    “We are looking to submit the data by the end of May and eventually look for an approval,” company MD Sharvil Patel said in response to queries by this newspaper.

    Incidentally though, the company has not published or released results from its phase 1, 2 trials showing safety and immunogenicity of the vaccine though it was submitted to the drug regulator before the last stage trials were started last month.  

    The company did not reply to our query on why isn’t it making the crucial data public, but Patel insisted that the phase 3 trials of vaccine will be truly representative of the efficacy of the vaccine against many of the known variants as different variants have surfaced in the ongoing wave of the Covid pandemic.

    ALSO READ |  Second jabs effective even at six months, don’t worry: Experts on Covishield dose gap

    “So, the trial outcomes will have more representative efficacy data than any other vaccine,” he said.  

    The vaccine, which is to be administered intradermally and in three doses, is being tested in over 28,000 plus volunteers, aged 12-99 years as per the phase 3 trial protocol submitted to the clinical trial registry of India.

    Patel, meanwhile, said that the company hopes to supply 5 crore doses by the end of this year. “We are also looking at further scaling up and are also exploring tech-transfers and partnerships,” he said.

    Though the hope of another Covid vaccine being available for India, grappling with acute shortage of vaccines while in the middle of a raging pandemic, comes as a welcome news, experts stressed on the need of maintaining due scientific rigour and processes.

    “Vaccines need to come with assurance of efficacy and safety and in the absence of clinical trial data to support the same will lead to vaccine hesitancy and lack  of trust,” said public health researcher Oommen john.

    Health policy expert and bioethicist Anant Bhan pointed out that the country is seeing a spate of emergency use authorisations, but it is extremely important that India continues to ensure that there is quality oversight, and transparency regarding decision making.

    “While presumably the regulator has access to phase 1, 2 data, it is crucial for these to also be publicly available. This is important for confidence in the process,” he said.