News Analysis India

Tag: Coronavirus Vaccine

  • India records 42,618 Covid cases, 330 deaths in a day; weekly positivity rate 2.63 per cent

    By PTI

    New Delhi, Sep 4 (PTI) India’s COVID-19 infection tally rose by 42,618 in a day to reach 3,29,45,907 while the number of active cases touched 4,05,681 following an increase for the third consecutive day, according to the Union Health Ministry data updated on Saturday.

    The death toll climbed to 4,40,225 with 330 more people succumbing to the viral disease, showed the data updated at 8 am.

    In a span of 24 hours, the active caseload rose by 5,903.

    The number of active cases now comprise 1.23 per cent of the total infections, while the national COVID-19 recovery rate was recorded at 97.43 per cent, the ministry said.

    The daily positivity rate was recorded 2.50 per cent and the weekly positivity rate was 2.63 per cent.

    It has been below three per cent for the last 71 days.

    India’s COVID-19 tally had crossed the 20-lakh mark on August 7 last year, 30 lakh on August 23, 40 lakh on September 5 and 50 lakh on September 16.

    It went past 60 lakh on September 28, 70 lakh on October 11, crossed 80 lakh on October 29, 90 lakh on November 20 and surpassed the one-crore mark on December 19.

    India crossed the grim milestone of two crore on May 4 this year and three crore on June 23.

  • DCGI gives nod for phase 2/3 trials of Biological E’s Covid vaccine on those aged between 5 & 18

    By PTI

    NEW DELHI: The Drugs Controller General of India (DCGI) on Wednesday granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trials of its ‘Made in India’ COVID-19 vaccine on children aged between 5 and 18 years with certain conditions, sources said.

    The phase 2 and 3 clinical trials have to be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo-controlled, Phase-2/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents’, a source said.

    The trial will be conducted across 10 sites in the country.

    The DCGI’s permission was given based on the recommendations by the Subject Expert Committee (SEC) on COVID-19.

    So far, indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.

    Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech’s Covaxin in the age group 2 to 18 years is underway.

    India’s drug regulator in July granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.

    Biological E’s anti-coronavirus shot, Corbevax, which is an RBD protein sub-unit vaccine is currently undergoing phase 2/3 clinical trials on adults, sources had said earlier.

    Biological E will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June.

    The ministry finalised arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses, an official statement had said.

    The Biological E COVID-19 vaccine candidate has been supported by Government of India from preclinical stage to phase 3 studies.

    The Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a Health Ministry statement had stated.

  • Two more vaccines line up for regulatory nod

    By Express News Service

    NEW DELHI:  India’s pool of Covid-19 vaccines is set to receive a shot in the arm with two more approaching the apex drug regulator for approval. Vaccines which have applied to Central Drugs Standard Control Organisation for restricted use authorisation include Novavax, manufactured locally by the Serum Institute of India under the brand name of Covovax, and Johnson and Johnson’s single dose vaccine.

    Sources in CDSCO said the companies moved the application on Thursday and a meeting of an expert panel has been called to scrutinise their data. SII had started production of Covovax for stockpiling in June. This showed over 90% efficacy in Phase 3 trials in the US. It is looking to launch the vaccine in India by September. 

    Johnson and Johnson’s single dose is also seen as a crucial component in coming days as it may be logistically easy to administer and offer quick coverage. A bid by the Association of Healthcare Providers of India to procure Johnson and Johnson’s vaccines in private hospitals, had failed last month due to regulatory hurdles. 

    Nearly seven months since the launch of the nationwide Covid-19 vaccination programme, only about 8% of the adult population in India has been fully vaccinated yet.

  • Hopeful of launching Covovax for adults in October this year, for children in Q1-2022: Serum CEO

    By PTI

    NEW DELHI: Serum Institute of India CEO Adar Poonawalla on Friday said he is hopeful that Covovax, another COVID-19 vaccine being manufactured by his company in India, will be launched in October for adults and for children by the first quarter of 2022.

    He also thanked the government for all the support provided to Serum Institute and said the company is always trying to expand its Covishield production capacity to meet the demand.

    Poonawalla met Home Minister Amit Shah in Parliament and the meeting between the two lasted for 30 minutes.

    “The government is helping us and we are facing no financial crunch. We are thankful to Prime Minister Narendra Modi for all the cooperation and support,” Poonawala told PTI after his meeting.

    When asked about vaccines for kids, he said, “The Covovax vaccine for kids will be launched in the first quarter of the next year most likely in January-February.”

    Poonawala said he is hopeful that for adults Covovax will be launched in October, depending on DCGI approvals.

    It will be a two-dose vaccine and the price will be decided at the time of launch, he added.

    On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.

    Earlier in the day, Poonawalla also met Health Minister Mansukh Mandaviya.

    The minister tweeted that he had a productive discussion on the supply of the Covishield vaccine with Poonawalla.

    “I appreciated their role in mitigating #COVID19 & assured continued Government support in ramping up vaccine production,” Mandaviya said.

    Last month, an expert panel of India’s Central Drug Authority recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions, official sources had earlier said.

    The trials would cover 920 children, 460 each in the age group of 12-17 and 2-11 across 10 sites.

    The Pune-based pharmaceutical company had submitted a revised protocol for inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer-blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab.

    In the revised application, SII director (government and regulatory affairs) Prakash Kumar Singh and director Dr Prasad Kulkarni had stated that globally, all adults aged 18 and above are being vaccinated and after this population is protected against COVID-l9, children will remain the most susceptible group.

    Currently, only those who are 18 or above are eligible for vaccination against the coronavirus.

    The SII is learnt to have informed that their collaborator, Novavax, Inc, US has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on the Novavax COVID-I9 vaccine are very robust which includes a safety database of more than 50000 adults with data from Australia, South Africa, UK and USA and preliminary safety data in 2248 children.

    “Further in the ongoing Phase 2/3 study in India, more than 1400 participants have received at least first dose of the vaccine with no safety concerns reported so far,” the application stated.

    “This will ensure that a life-saving vaccine can be brought at the earliest for our pediatric population also in addition to the adult population immediately after the grant of Emergency Use Authorisation.

    The SEC on June 30 had recommended against granting permission to SII for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years following which the company had submitted a revised study protocol last week.

    In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

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  • Pfizer, AstraZeneca vaccine antibody levels may decline after 2-3 months: Lancet study

    By PTI
    LONDON: Total antibody levels start to wane six weeks after complete immunisation with Pfizer and AstraZeneca vaccines, and can reduce by more than 50 per cent over 10 weeks, according to study published in The Lancet journal.

    The researchers from University College London (UCL) in the UK noted that if the antibody levels carry on dropping at this rate, there are concerns that the protective effects of the vaccines may also begin to wear off, particularly against new variants.

    However, they said, how soon that might happen cannot be predicted yet.

    The UCL Virus Watch study also found that antibody levels are substantially higher following two doses of the Pfizer vaccine than after two shots of the AstraZeneca preventive, known as Covishield in India.

    Antibody levels were also much higher in vaccinated people than those with prior SARS-CoV-2 infection, they said.

    “The levels of antibody following both doses of either the AstraZeneca or Pfizer vaccine were initially very high, which is likely to be an important part of why they are so protective against severe COVID-19,” said Madhumita Shrotri from UCL Institute of Health Informatics.

    “However, we found these levels dropped substantially over the course of two to three months,” Shrotri said in a statement.

    The findings based on data from over 600 people aged 18 and above were consistent across all groups of people regardless of age, chronic illnesses or sex, according to the researchers.

    The authors highlight that although the clinical implications of waning antibody levels are not yet clear, some decline was expected and current research shows that vaccines remain effective against severe disease.

    For Pfizer, antibody levels reduced from a median of 7506 Units per millilitre (U/mL) at 21–41 days, to 3320 U/mL at 70 or more days.

    For AstraZeneca vaccine, antibody levels reduced from a median of 1201 U/mL at 0–20 days to 190 U/mL at 70 or more days, over five-fold reduction.

    “When we are thinking about who should be prioritised for booster doses our data suggests that those vaccinated earliest, particularly with the AstraZeneca vaccine, are likely to now have the lowest antibody levels,” said Professor Rob Aldridge from UCL Institute of Health Informatics.

    The findings support recommendations that adults who are clinically vulnerable, those aged 70 years or over, and all residents of care homes for older adults should be prioritised for booster doses, the researchers said.

    In addition, those who were vaccinated with the AstraZeneca vaccine are likely to have much lower antibody levels than those vaccinated with the Pfizer vaccine, they noted.

    “This may also need to be considered when deciding who should be prioritised when boosters are rolled out,” Aldridge said in the statement.

    The team acknowledged certain limitations in the data, including a small sample size for some groups.

    The researchers noted that that each individual only contributed one sample, so they cannot yet confirm how quickly antibody levels drop for each individual, or whether these would continue to drop or reach a stable level over the next few months.

    They also noted that different people will have different levels of immunity depending on the virus neutralising ability of their antibodies as well as their T-cell responses.

    “Even when measurable antibody levels are low, there is likely to be continuing immune memory that could offer long-term protection,” the authors of the study noted.

    They said further research will be important to establish if there is an antibody level threshold needed for protection against severe disease.

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  • Nine countries in Europe accepting Covishield for travel: Sources

    Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are among the countries allowing travel by people who have taken Covishield vaccines, the sources said.

  • Despite claims of ramping up manufacturing, Covaxin laggard in vaccine pool, shows affidavit

    Express News Service
    NEW DELHI:  In sharp contrast to the claims of Bharat Biotech on ramping up Covaxin’s production, only about 2.8 crore of its doses had been made available for the ongoing vaccination drive till June 12. This information was part of the 380-page affidavit the Union health and family welfare ministry filed in the Supreme Court on Saturday. 

    Of the over 32 crore vaccine doses administered so far, the share of Covishield, produced by Serum Institute of India, is more than 90%. The latest revelation on Covaxin’s low availability indicates the Hyderabad-based vaccine maker has been able to supply only about 50 lakh doses per month so far even though it has been claiming that it is constantly scaling up its manufacturing capacity and had reached 2 crore per month capacity in May. 

    The Centre issued purchase orders for 8 crore Covaxin doses till July this year in three instalments but the company after supplying the initial order of 1 crore doses over 2 months, was yet to supply 18,36,840 doses of the 2-crore order placed for March-May, as on June 12. 

    Despite the massive delays, the Centre went ahead and paid an advance amount for 5 crore Covaxin doses between May and July, the affidavit shows. Further, on June 4, the government paid the firm 30% of the total costs for 27 crore doses of Covaxin, at the rate of Rs 150 per dose, for supplies between August and December.

    The ministry in April had said that Bharat Biotech will produce 2 crore doses a month by May-June and 6-7 crore in July-August, though its capacity that month was 1 crore. A request to Bharat Biotech seeking its response on the slow supplies of Covaxin, has remained unanswered so far. 

    Meanwhile, the affidavit, scaled down the projected August-December availability of vaccines to 1.35 billion doses from 2.16 billion. It includes 50 crore doses of Covishield and 30 crore doses of Biological E’s candidate, which is yet to complete phase 3 trial. 

    Covishield dose gap cut for students going abroadThe Centre also told the SC that it has relaxed the 12-16 weeks time interval for the second dose of Covishield for athletes bound for Olympics, students undertaking foreign travel for education and persons working abroad

  • Heartening to note 3 out of 5 people vaccinated on June 21 were from rural areas: Vice President Naidu

    By PTI
    NEW DELHI: Vice President M Venkaiah Naidu said it was heartening to note that three out of five people vaccinated as part of the COVID-19 inoculation drive on June 21 were from rural areas, where the majority of the country’s population resides.

    According to the government, of the record 88.09 lakh vaccine doses administered on June 21, when the revised guidelines for COVID-19 vaccination came into effect, nearly 64 per cent of the jabs were given in rural areas.

    “It is heartening to note that 3/5 persons vaccinated in the stepped up drive on Monday were from rural areas, where the majority of population resides.

    My compliments to the Centre and various states for working in a coordinated manner in a truly ‘Team India’ spirit,” the Vice President Secretariat quoted Naidu as saying in a tweet on Wednesday.

    States that have done extremely well must share their best practices with others to achieve optimal results, he said.

    “I also urge people to proactively come forward and get themselves vaccinated,” he added.

    As of Tuesday, India’s cumulative COVID-19 vaccination coverage had crossed the 29-crore mark, according to the Union health ministry.

  • End politics, time for everyone to gain from vaccination: Mayawati

    There have been enough politics, controversy and allegations regarding the manufacture of vaccines and people have borne the brunt of it, Mayawati said in a tweet.

  • With over 16 lakh COVID-19 vaccinations, Madhya Pradesh tops India’s vaccination chart on June 21

    By ANI
    BHOPAL: Madhya Pradesh on Monday administered 16,73,858 COVID-19 vaccine doses, the highest ever among states in the country in a single day so far.

    As the new phase of universalisation of COVID-19 vaccination commenced from Monday, in a landmark achievement, 80,95,314 doses have been administered on the first day of the new phase of COVID-19 Vaccination. This is the highest single-day number of jabs in the world.

    According to a statement issued by the Madhya Pradesh government, a total of 3,75,962 vaccine doses were administered in the Bhopal division which includes 8 districts – Betul, Bhopal, Harda, Hoshangabad, Raisen, Rajgarh, Sehore and Vidisha on Monday, as part of state’s ‘Vaccination Mahaabhiyan’ campaign that coincided with the International Day of Yoga.

    As many as 3,88,401 vaccine doses were administered in the Indore division which comprises 8 districts – Alirajpur, Barwani, Burhanpur, Dhar, Indore, Jhabua, Khandwa and Khargone. The Gwalior Division, comprising 8 districts – Ashoknagar, Bhind, Datia, Guna, Gwalior Morena, Sheopur and Shivpur, administered 1,93,435 jabs.

    The Jabalpur division which comprises 8 districts – Balaghat, Chhindwara, Dindori, Jabalpur, Katni, Mandla, Narsinghpur and Seoni, recorded 2,07,160 doses. As many as 2,54,757 vaccine doses were administered in the Ujjain Division which comprises seven districts including Agar, Dewas, Mandsaur, Neemuch, Ratlam, Shajapur and Ujjain.

    In the Sagar division which includes 5 districts – Chhatarpur, Damoh, Panna, Sagar and Tikamgarh, 1,01,351 vaccine doses were administered on Monday.

    As many as 152792 vaccine doses were administered in the Rewa Division which comprises 7 districts including Anuppur, Rewa, Satna, Shahdol, Sidhi, Singrauli and Umaria.

    As the centralised free vaccination policy began on Monday under which the Government of India will provide free COVID-19 vaccine to all citizens above 18 years of age, Madhya Pradesh Chief Minister Shivraj Singh Chouhan informed that the state government has set up 7,000 centres under the ‘Vaccination Mahaabhiyan’ campaign to intensify the inoculation drive.

    Speaking to the media, Chouhan said, “On one hand we are strengthening healthcare infrastructure and conducting maximum testing, and on the other hand, we have to ensure mass vaccination.”