Serum Institute gets nod to export vaccines to COVAX
The Pune based vaccines manufacturer Serum Institute of India (SII) has got the nod to export Covid vaccines under the COVAX programme, said a source on Monday.
Booster dose of 6 Covid vaccines is safe, increases immunity, shows study in Lancet
The study looked at safety, immune response and side-effects of seven vaccines — Oxford-AstraZeneca, Pfizer-BioNTech, Novavax, Janssen, Moderna, Valneva and Curevac.
theprint.in
Bharat Biotech resumes export of Covaxin amid Omicron variant scare
The Modi government on Tuesday, 24 November, had approved the commercial export of Bharat Biotech's Covid-19 vaccine..Covaxin, India's first indigenous vaccine for Covid-19, has been found to be 77.8 per cent effective against the coronavirus
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Government panel seeks additional data from SII on Covovax
In August 2020, U.S.-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
An expert panel of India's Central Drug Authority, which recently reviewed Serum Institute's application seeking emergency authorisation of COVID-19 vaccine Covovax, has sought additional data from the firm, while noting the jab has not yet been approved in the country of origin, official sources said.The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the U.K. and the U.S. along with its application, official sources said.
"The Subject Expert Committee [SEC] on COVID-19 of the Central Drugs Standard Control Organisation [CDSCO], which deliberated on the application on November 24, noted that the vaccine is technology transfer of Novavax vaccine and is not yet approved in the country of origin," a source said.
After detailed deliberation, the committee recommended that the firm should submit additional data and information.
It has sought correct status of the phase 3 clinical trials in the United States of America and the United Kingdom along with up to date on the safety, efficacy and immunogenicity, comparative statement of immunogenicity parameters of the subjects from the U.S., U.K. and other overseas phase 3 studies with data from phase 3 study in India, besides review status of the application with regulatory authorities of the U.S. and the U.K., the source said.
The government recently permitted the export of two crore doses of COVID-19 vaccine Covovax to Indonesia, produced in India by the SII, as the jab has not yet been approved for emergency use in the country, official sources had said.
The DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on the DCGI's approval, till now, the Pune-based firm has manufactured and stockpiled vaccine doses, they said.
In August 2020, U.S.-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.
Government panel seeks additional data from SII on Covovax
In August 2020, U.S.-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
Serum Institute of India delivers first Novavax vaccine batch through COVAX
Serum Institute of India has sent doses of COVID-19 vaccine to Indonesia, in its first export of the Novavax shot through the COVAX network, Central Government said on Wednesday.The world's biggest vaccine maker exported 137,500 doses of Covovax, as it calls the shot, to the Southeast Asian country last week.
Indonesia has approved the vaccine but India and the World Health Organization, which co-leads the COVAX vaccine-sharing network, have not.
Serum Institute of India delivers first Novavax vaccine batch through COVAX
India and the World Health Organisation are yet to approve Novavax’s COVID-19 vaccine
Central Drug Regulator Approves Shelf Life Of COVID-19 Vaccines CoviShield, Covaxin, ZyCoV-D
New Delhi:The Central Drugs Standard Organisation (CDSO) has approved the shelf life of COVID-19 vaccines Covaxin to 12 months, Covishield to nine months, and ZyCoV-D to six months from the date of manufacture, the Lok Sabha was informed on Friday.
Regarding administration of booster doses, Union Health Minister Mansukh Mandaviya said the National Technical Advisory Group on Immunisation (NTAGI) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) are deliberating and considering scientific evidences related to this aspect.
Responding to a question on the shelf life of Covid vaccines approved in the country and their active period among the vaccinated people, Mr Mandaviya, in a written reply, said the vaccines were developed very recently, therefore, scientific evidence regarding the duration of protection is still evolving globally.
"The National Regulator, i.e. the CDSO, has approved the shelf life of nine months for Covishield vaccine, for Covaxin vaccine it is 12 months and for ZyCoV-D vaccine it is six months from the date of manufacture," Mr Mandaviya said.
On whether the government has taken stock of vaccines lying unused in government and private hospitals and proposes to procure and redistribute the unused vaccines before their dates of expiry, Mr Mandaviya said the central government closely monitors COVID-19 vaccine stocks in states and Union Territories to ensure their optimal utilisation.
COVID-19 vaccine stock which has not been utilised in private hospitals and nearing expiry has been taken up for redistribution by respective state governments, as advised by the Union government, for their timely utilisation, he said.
Listing steps taken by the government to ensure adequate production and supply of Covid vaccines and booster doses along with the total expenses incurred and funds allocated and disbursed in this regard, Mr Mandaviya said under 'Mission Covid Suraksha' being implemented by the Biotechnology Industry Research Assistance Council (BIRAC), a PSU of Department of Biotechnology, efforts have been made to strengthen COVID-19 vaccine manufacturing capabilities of Indian industry, to ensure optimal vaccine production.
In this regard, augmentation of manufacturing facilities was supported at Bharat Biotech International Limited (BBIL) and Indian Immunologicals Limited (IIL), Hyderabad.
The IIL, supported under the mission, has achieved a production capacity of around 20 lakh doses/month equivalent Drug Substance (DS) of Covaxin.
The validation of the BBIL facility at Malur, Bengaluru is complete and production of DS started in August 2021. Further, support for facility augmentation at Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL), Bulandshahr; and Haffkine Biopharmaceutical Corporation Ltd (HBPCL), Mumbai; for Covaxin production is under consideration.
An amount of ₹ 260 crore has been allocated to support facility upgradation for augmented Covaxin production, out of which, an amount of ₹ 27.25 crore has been disbursed so far, Mr Mandaviya said.
Additionally, DBT along with the PSU BIRAC, is facilitating expert advisory support for facility up-gradation at Gujarat COVID Vaccine Consortium (GCVC), for augmented production of Covaxin, he said in the written reply.
In the current financial year i.e. 2021-22, ₹ 35,000 crore has been budgeted for implementation of COVID-19 vaccination programme.
As on November 27, an expenditure of INR 19,675.46 crore has been incurred against this allocation which has been utilised for procurement of COVID-19 vaccines for free of cost supply to states and Union Territories, he said.
Central Drug Regulator Approves Shelf Life Of COVID-19 Vaccines CoviShield, Covaxin, ZyCoV-D
The Central Drugs Standard Organisation (CDSO) has approved the shelf life of COVID-19 vaccines Covaxin to 12 months, Covishield to nine months, and ZyCoV-D to six months from the date of manufacture, the Lok Sabha was informed on Friday.
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Brain problems found in 1 percent of hospitalised COVID-19 patients; real-world data shows Moderna vaccine highly effective
The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review, Reuters reported.Brain problems seen in 1 percent of hospitalised COVID-19 patients
Roughly one in every 100 patients hospitalised with COVID-19 will likely have central nervous system complications, researchers reported on November 30 at the annual meeting of the Radiological Society of North America.
Among nearly 38,000 patients hospitalised with COVID-19 in the United States and Europe, symptoms led doctors to suspect brain complications in about 11 percent.
Magnetic resonance imaging (MRI) and computed tomography (CT) exams confirmed central nervous system abnormalities that were most likely associated with the virus in 10 percent of those patients, for an overall incidence of 1.2 percent.
Study leader Dr Scott Faro of Thomas Jefferson University in Philadelphia said in a statement that while the lung problems related to COVID-19 are well recognised, "Our study shows that central nervous system complications represent a significant cause of morbidity and mortality in this devastating pandemic."
Moderna vaccine effectiveness not limited to clinical trials
Moderna's mRNA COVID-19 vaccine is proving effective in the real world, according to doctors at Kaiser Permanente in California who have been tracking nearly 706,000 adults, half of whom had received the vaccine.
Five months after the second dose, the vaccine was still 87 percent effective against SARS-CoV-2 infection, 96 percent effective against COVID-19 hospitalisation, and 98 percent effective against COVID-19 death, researchers reported in The Lancet Regional Health - Americas.
Despite a wide range of chronic diseases among those in the study, the vaccine's effectiveness against infection ranged from 83 percent to 92 percent across age, sex, racial, and ethnic subgroups, researchers said.
Immunologist E. John Wherry of the University of Pennsylvania, who was not involved in the Kaiser study, said it is "highly unlikely" that the Omicron variant of the virus can completely evade all of the immune defences induced by the vaccines and that current boosters will likely "provide increased protection against this variant."
COVID-19 at childbirth linked with higher risks; antibody drugs appear to be safe
Pregnant women with COVID-19 face higher risks of childbirth complications than those who are not infected by the coronavirus, a new study found.
A separate study suggests mildly or moderately ill pregnant women with COVID-19 can safely be treated with monoclonal antibody drugs such as those from Regeneron Pharmaceuticals.
The analysis of childbirth complications included 244,645 births, 874 of which were in infected women.
Researchers reported on November 30 in PLOS Medicine that miscarriage and stillbirth rates did not differ between the groups.
But after accounting for women's risk factors, researchers found that those with COVID-19 had 80 percent higher odds of having too much amniotic fluid, doubled odds of dangerously high blood pressure, more than doubled odds of amniotic infection, nearly tripled odds of hemorrhage during delivery, and nearly doubled odds of hemorrhage afterward. They were also at higher risk for preterm delivery.
"Pregnant women and those who plan to conceive... are strongly encouraged to be vaccinated," said study leader Dr. Sylvie Epelboin of the University of Paris.
Meanwhile, doctors at the Mayo Clinic in Rochester, Minnesota treated 51 pregnant patients with mild-to-moderate COVID-19 with one of several monoclonal antibody treatments.
"No adverse effects were reported, and no patient required COVID-19 related hospitalization," they reported on Sunday on medRxiv ahead of peer review.
So far, 29 of the women have delivered healthy babies. There was one miscarriage due to a congenital defect not related to the medication.
The investigators note that while the infusions were well tolerated, the study was a small one.
Further research is recommended to fully assess safety and efficacy in pregnancy, they said.
The long and tumultuous journey of Amtek Auto’s insolvency process
The beleaguered auto parts maker was among the first batch of bankrupt companies to be referred for insolvency resolution back in 2017 but the hurdles faced in this instant case made the road to revival a long and bumpy one.
Coronavirus vaccine for Kids: India’s first needle-free 3-dose COVID vaccine for 12+ ZyCoV-D is here: All you need to know about it
Covaxin was India’s first indigenous vaccine against COVID-19 and now we have the second indigenous jab which will soon be available across seven Indian states. What makes ZyCoV-D vaccine unique is that it is a needle-less jab which had earned authorization from the Drugs Controller General of...
timesofindia.indiatimes.com
India to initially introduce ZyCoV-D Covid vaccine in 7 states. Details here
Pharmaceutical company Zydus Cadila will supply 1 crore doses of ZyCoV-D, the world's first Plasmid DNA Covid vaccine, to the Centre by this month.The Centre has already placed an initial order for one crore doses of the vaccine
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No new govt order, Covishield output to be cut by 50%: Serum Institute of India - Times of India
Times of India brings the Latest & Top Breaking News on Politics and Current Affairs in India & around the World, Cricket, Sports, Business, Bollywood News and Entertainment, Science, Technology, Health & Fitness news & opinions from leading columnists.
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India stuck with Covid-19 vaccines it can't export
The SII's monthly output of the AstraZeneca vaccine, which it brands Covishield, has nearly quadrupled since April to 250 million doses
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Serum Institute plans to launch Covid vaccine for children in six months
The Pune-based Serum Institute of India (SII) plans to launch a Covid-19 vaccine for children in the next six months even as it is developing an effective booster dose for doubly-vaccinated persons in the wake of virus undergoing mutation.
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COVID: Why is India's top vaccine maker cutting production?
The country's largest manufacturer said it would cut production of Covishield by half. The move comes as officials discuss booster shots and vaccines for children.
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