Delhi Health Minister and AAP leader Saurabh Bharadwaj has raised concerns about the Indian government’s decision to continue using the Covishield vaccine, despite most European nations banning it. According to reports, AstraZeneca has admitted in court documents to rare and dangerous side effects of its vaccine. Watch!
Tag: COVID 19 vaccine
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Bharat Biotech sends three lakh nasal shots to private hospitals
By Express News Service
NEW DELHI: Bharat Biotech has delivered three lakh doses of its nasal Covid-19 vaccine to private hospitals across India, the Hyderabad-based pharma company’s executive chairman Krishna Ella said on Sunday.
iNCOVACC, world’s first intranasal Covid-19 vaccine, was launched on January 26. The vaccine is now on sale CoWIN and priced at I800 for private markets and I325 for the state and Central government.“We dispatched three lakh doses of the nasal vaccine to some hospitals two days ago. Let us see the response. Some countries have approached us for (exporting) nasal vaccines.
We can’t reveal the names. International agencies are looking at it very critically,” Ella, executive chairman of Bharat Biotech, said on the sidelines of an event in which an MoU was signed between the University of Wisconsin (UW)-Madison Global Health Institute (GHI) and the Ella Foundation for the establishment of the first-ever UW-Madison One Health Centre in Bengaluru.
He also batted for merging all state drug regulatory bodies with the Central Drugs Standard Control Organisation (CDSCO) to ensure “one quality, one standard” for Indian drugs. His remarks came in the backdrop of a third incident of India-made drugs being linked with reported deaths abroad since last October.
On Friday, Chennai-based Global Pharma Healthcare recalled its eye drops linked to vision loss and death in the US following US Food and Drug Administration (FDA) restricting its imports. The pharma company has also been asked to stop all its productions under the category of ophthalmic preparation.
NEW DELHI: Bharat Biotech has delivered three lakh doses of its nasal Covid-19 vaccine to private hospitals across India, the Hyderabad-based pharma company’s executive chairman Krishna Ella said on Sunday.
iNCOVACC, world’s first intranasal Covid-19 vaccine, was launched on January 26. The vaccine is now on sale CoWIN and priced at I800 for private markets and I325 for the state and Central government.
“We dispatched three lakh doses of the nasal vaccine to some hospitals two days ago. Let us see the response. Some countries have approached us for (exporting) nasal vaccines.We can’t reveal the names. International agencies are looking at it very critically,” Ella, executive chairman of Bharat Biotech, said on the sidelines of an event in which an MoU was signed between the University of Wisconsin (UW)-Madison Global Health Institute (GHI) and the Ella Foundation for the establishment of the first-ever UW-Madison One Health Centre in Bengaluru.
He also batted for merging all state drug regulatory bodies with the Central Drugs Standard Control Organisation (CDSCO) to ensure “one quality, one standard” for Indian drugs. His remarks came in the backdrop of a third incident of India-made drugs being linked with reported deaths abroad since last October.
On Friday, Chennai-based Global Pharma Healthcare recalled its eye drops linked to vision loss and death in the US following US Food and Drug Administration (FDA) restricting its imports. The pharma company has also been asked to stop all its productions under the category of ophthalmic preparation.
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‘Not liable to compensate for deaths due to Covid vaccine,’ Centre tells SC
Express News Service
NEW DELHI: The Centre on Tuesday informed the Supreme Court that the government cannot be held liable for adverse effects due to the administration of vaccine against Covid-19 and compensation for death induced due to vaccine cannot be sought by filing a suit in court.
The affidavit filed in the apex court by the Centre assumes significance in view of the fact that the government has been zealously pursuing the Covid-19 vaccination programme to fight the pandemic and, as per latest reports, over 219 crore doses have been administered.
The affidavit was filed in response to a petition by the parents of two girls who died allegedly due to adverse effects of Covishield vaccine. The daughters of the petitioners were aged 19 and 20 years.
A health worker holds up a Covishield vial. (File Photo | EPS)
The Centre claimed vaccines manufactured by third parties had successfully undergone regulatory review, and holding the state directly liable to provide compensation may not be legally sustainable.
“If a person suffers physical injury or death due to an AEFI (Adverse Events Following Immunization), appropriate remedies in law are open to the vaccine beneficiary or their family including approaching civil courts for a claim of damages/compensation for negligence, malfeasance or misfeasance. Such claims may be determined on a case-to-case basis in an appropriate forum. There is no material to suggest how the State can be fastened with strict liability for the tragic,” the affidavit states.
It has also been stated in the affidavit that vaccination of eligible population under the National Covid-19 Vaccination Program is ‘voluntary.’
It further is added, “The Operational Guidelines issued by the Central Government to all States/UTs clearly state that vaccination is voluntary. The concept of informed. consent is inapplicable to the voluntary use of a drug such as a vaccine. While the Government of India strongly encourages all eligible persons to undertake vaccination in public interest, there is no legal compulsion for the same.”
“AEFI investigation and causality assessment process is a completely transparent process. AEFIs are thoroughly examined and results are made publicly available as soon as possible. existing mechanism for monitoring, investigation and analysis of AEFIs is adequate, effective and transparent,” the affidavit states.
NEW DELHI: The Centre on Tuesday informed the Supreme Court that the government cannot be held liable for adverse effects due to the administration of vaccine against Covid-19 and compensation for death induced due to vaccine cannot be sought by filing a suit in court.
The affidavit filed in the apex court by the Centre assumes significance in view of the fact that the government has been zealously pursuing the Covid-19 vaccination programme to fight the pandemic and, as per latest reports, over 219 crore doses have been administered.
The affidavit was filed in response to a petition by the parents of two girls who died allegedly due to adverse effects of Covishield vaccine. The daughters of the petitioners were aged 19 and 20 years.
A health worker holds up a Covishield vial. (File Photo | EPS)
The Centre claimed vaccines manufactured by third parties had successfully undergone regulatory review, and holding the state directly liable to provide compensation may not be legally sustainable.
“If a person suffers physical injury or death due to an AEFI (Adverse Events Following Immunization), appropriate remedies in law are open to the vaccine beneficiary or their family including approaching civil courts for a claim of damages/compensation for negligence, malfeasance or misfeasance. Such claims may be determined on a case-to-case basis in an appropriate forum. There is no material to suggest how the State can be fastened with strict liability for the tragic,” the affidavit states.
It has also been stated in the affidavit that vaccination of eligible population under the National Covid-19 Vaccination Program is ‘voluntary.’
It further is added, “The Operational Guidelines issued by the Central Government to all States/UTs clearly state that vaccination is voluntary. The concept of informed. consent is inapplicable to the voluntary use of a drug such as a vaccine. While the Government of India strongly encourages all eligible persons to undertake vaccination in public interest, there is no legal compulsion for the same.”
“AEFI investigation and causality assessment process is a completely transparent process. AEFIs are thoroughly examined and results are made publicly available as soon as possible. existing mechanism for monitoring, investigation and analysis of AEFIs is adequate, effective and transparent,” the affidavit states.
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50 million doses of Covaxin set to expire in early 2023 due to poor demand
By PTI
HYDERABAD: Nearly 50 million doses of Bharat Biotech’s COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
Due to lack of product demand, production stoppage of Covaxin- a two dose jab, was initiated by Bharat Biotech earlier this year, though the vaccine maker has established manufacturing to reach an annualised capacity of 1 billion doses at the end of 2021.
“Bharat Biotech has more than 200 million doses of Covaxin in bulk form and approximately 50 million doses in vials ready to use. Due to lack of product demand, production stoppage of Covaxin was initiated several months ago, earlier this year,” sources told PTI.
“Covaxin doses in vials are set to expire during early 2023, resulting in losses for the company,” sources further said.
However, the quantum of loss that the Bharat Biotech would incur in the event of all the 50 million doses expiring next year is not known.
India reported 1,082 fresh COVID-19 cases on Saturday, while the number of active cases declined to 15,200, according to Union health ministry data.
ALSO READ | China launches a COVID-19 vaccine inhaled through the mouth
So far, 219.71 crore doses of COVID-19 vaccines, including Covaxin have been administered under the nationwide vaccination drive. As the infection rate has been sturdily declining globally, exports of Covaxin were negatively impacted with poor off take by foreign countries.
“COVID-19 is not considered a threat anymore globally,” sources added. In April this year, the World health Organization (WHO) said it confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended that countries using the vaccine take action as appropriate.
A statement issued by WHO then said the suspension is in response to the outcome of its post EUL (emergency use authorisation) inspection held between March 14- 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
When the COVID-19 infection was at its peak during 2021, the Brazil government suspended its decision to import 20 million doses of Covaxin following a controversy that attracted investigation by authorities in that country.
Bharat Biotech on July 23, 2021 said it terminated the MoU it entered into with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for Brazilian market.
In December 2021, Bharat Biotech said, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of its COVID-19 vaccine Covaxin’s shelf life up to 12 months from the date of manufacture.
HYDERABAD: Nearly 50 million doses of Bharat Biotech’s COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
Due to lack of product demand, production stoppage of Covaxin- a two dose jab, was initiated by Bharat Biotech earlier this year, though the vaccine maker has established manufacturing to reach an annualised capacity of 1 billion doses at the end of 2021.
“Bharat Biotech has more than 200 million doses of Covaxin in bulk form and approximately 50 million doses in vials ready to use. Due to lack of product demand, production stoppage of Covaxin was initiated several months ago, earlier this year,” sources told PTI.
“Covaxin doses in vials are set to expire during early 2023, resulting in losses for the company,” sources further said.
However, the quantum of loss that the Bharat Biotech would incur in the event of all the 50 million doses expiring next year is not known.
India reported 1,082 fresh COVID-19 cases on Saturday, while the number of active cases declined to 15,200, according to Union health ministry data.
ALSO READ | China launches a COVID-19 vaccine inhaled through the mouth
So far, 219.71 crore doses of COVID-19 vaccines, including Covaxin have been administered under the nationwide vaccination drive. As the infection rate has been sturdily declining globally, exports of Covaxin were negatively impacted with poor off take by foreign countries.
“COVID-19 is not considered a threat anymore globally,” sources added. In April this year, the World health Organization (WHO) said it confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended that countries using the vaccine take action as appropriate.
A statement issued by WHO then said the suspension is in response to the outcome of its post EUL (emergency use authorisation) inspection held between March 14- 22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
When the COVID-19 infection was at its peak during 2021, the Brazil government suspended its decision to import 20 million doses of Covaxin following a controversy that attracted investigation by authorities in that country.
Bharat Biotech on July 23, 2021 said it terminated the MoU it entered into with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for Brazilian market.
In December 2021, Bharat Biotech said, the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of its COVID-19 vaccine Covaxin’s shelf life up to 12 months from the date of manufacture.
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CAA will be implemented after Covid-19 vaccine drive is over, says Amit Shah
By PTI
NEW DELHI: BJP leader from West Bengal Suvendu Adhikari Tuesday urged Union Home Minister Amit Shah to implement the citizenship law CAA at the earliest, with the latter assuring him that rules regarding it will be framed after the Covid precaution dose vaccination exercise is over.
The framing of rules for the Citizenship (Amendment) Act will pave the way for its implementation.
Passed by Parliament in December 2019, the Act is yet to be rolled out due to the absence of rules.
The government has cited the outbreak of pandemic for not framing them so far.
Adhikari, the leader of the opposition in the state assembly, told reporters after meeting Shah that he also handed him a list of nearly 100 Trinamool Congress leaders allegedly involved in the recruitment scam in which former West Bengal minister Partha Chatterjee has been arrested.
Seeking a wider probe to expose everyone involved in the scandal, Adhikari gave the home minister even letterheads of some TMC leaders, including MLAs, that were purportedly used for recommending certain names for jobs by allegedly taking bribes.
He tweeted after meeting Shah, “It’s an honour for me to meet Union Home Minister Amit Shah for 45 minutes at his office in Parliament. I briefed him how WB Govt is completely mired in corrupt activities such as the teachers recruitment scam. Also requested him to implement CAA at the earliest.”
Adhikari told reporters that the issue of CAA, slammed by critics for its alleged anti-Muslim bias, implementation is very critical for West Bengal where a large number of people who can benefit from its provisions.
The CAA was passed by Parliament on December 11, 2019, and the Act was notified within 24 hours on December 12.
In May, while addressing a rally in Bengal, Shah had said that the law would be implemented once the Covid pandemic ends.
There is a view that the government is treading cautiously on the matter after the Act drew saw protests in different parts of the country.
It seeks to grant citizenship to persecuted minorities of neighbouring countries, Bangladesh, Pakistan and Afghanistan, who had come to India by December 31, 2014.
Speaking to reporters, West Bengal BJP president Sukanta Majumder also hit out at TMC leader and state Chief Minister Mamata Banerjee, alleging that without indications from her the recruitment scam could not have happened.
“It is an organised crime. There was a ‘cut money food chain’ and some people would be based in every district to pick money and channel it through the party (TMC) organisation,” he alleged.
Adhikari said careers of around 80-90 lakh teacher job aspirants were ruined by the scam. They have remained unemployed due to this, he said.
NEW DELHI: BJP leader from West Bengal Suvendu Adhikari Tuesday urged Union Home Minister Amit Shah to implement the citizenship law CAA at the earliest, with the latter assuring him that rules regarding it will be framed after the Covid precaution dose vaccination exercise is over.
The framing of rules for the Citizenship (Amendment) Act will pave the way for its implementation.
Passed by Parliament in December 2019, the Act is yet to be rolled out due to the absence of rules.
The government has cited the outbreak of pandemic for not framing them so far.
Adhikari, the leader of the opposition in the state assembly, told reporters after meeting Shah that he also handed him a list of nearly 100 Trinamool Congress leaders allegedly involved in the recruitment scam in which former West Bengal minister Partha Chatterjee has been arrested.
Seeking a wider probe to expose everyone involved in the scandal, Adhikari gave the home minister even letterheads of some TMC leaders, including MLAs, that were purportedly used for recommending certain names for jobs by allegedly taking bribes.
He tweeted after meeting Shah, “It’s an honour for me to meet Union Home Minister Amit Shah for 45 minutes at his office in Parliament. I briefed him how WB Govt is completely mired in corrupt activities such as the teachers recruitment scam. Also requested him to implement CAA at the earliest.”
Adhikari told reporters that the issue of CAA, slammed by critics for its alleged anti-Muslim bias, implementation is very critical for West Bengal where a large number of people who can benefit from its provisions.
The CAA was passed by Parliament on December 11, 2019, and the Act was notified within 24 hours on December 12.
In May, while addressing a rally in Bengal, Shah had said that the law would be implemented once the Covid pandemic ends.
There is a view that the government is treading cautiously on the matter after the Act drew saw protests in different parts of the country.
It seeks to grant citizenship to persecuted minorities of neighbouring countries, Bangladesh, Pakistan and Afghanistan, who had come to India by December 31, 2014.
Speaking to reporters, West Bengal BJP president Sukanta Majumder also hit out at TMC leader and state Chief Minister Mamata Banerjee, alleging that without indications from her the recruitment scam could not have happened.
“It is an organised crime. There was a ‘cut money food chain’ and some people would be based in every district to pick money and channel it through the party (TMC) organisation,” he alleged.
Adhikari said careers of around 80-90 lakh teacher job aspirants were ruined by the scam. They have remained unemployed due to this, he said.
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Biological E seeks EUA for its Corbevax vaccine for 12-18 yrs age group
By PTI
NEW DELHI: Biological E has sought emergency use authorisation from India’s drug regulator for its COVID-19 vaccine Corbevax for the 12 to 18 years age group, official sources said on Sunday.
The Drugs Controller General Of India (DCGI) has already approved Corbevax, which is India’s first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in emergency situation among adults on December 28.
In an application sent to DCGI on February 9, Srinivas Kosaraju, head of Quality and Regulatory Affairs of Biological E Limited, said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.
Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study, which indicated that the vaccine is safe and immunogenic.
“The proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase 2/3 clinical study) considering the current pandemic and widespread of COVID-19 vaccine in India,” Kosaraju said in the application.
The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.
According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its COVID-19 vaccine in the country.
Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.
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Vaccine effectiveness of 99.3 per cent seen in fully vaccinated: Mandaviya
By IANS
NEW DELHI: Vaccine effectiveness of 99.3 per cent has been seen in individuals fully inoculated against Covid as per the data uploaded on India Covid-19 Tracker till January 2, the Parliament was told on Friday.
The Indian Council of Medical Research (ICMR) has developed the India Covid-19 Vaccine Tracker, by merging mainly three national databases — CoWIN, National Covid-19 Testing database and Covid-19 India portal, Health Minister Mansukh Mandaviya told the Lok Sabha in a written reply.
“The latest data analysed and uploaded till January 2, 2022 depicts vaccine effectiveness of 99.3 per cent in fully vaccinated individuals against Covid-19,” he said, adding that the tracker is updated periodically and displays the effectiveness of partial and full vaccination against Covid-19.
He said that the Omicron variant is the dominant variant in the country presently. Whole genome sequencing for Omicron variant is done for all RTPCR positive samples from international travellers arriving since November 28, 2021.
Stressing that the Centre is supporting states in their endeavour to manage Covid-19 since the beginning of the pandemic, Mandaviya said that given the emergence of mutated variants with variable impact on transmissibility, virulence and effectiveness of vaccines, the likelihood of resurgence of Covid-19 trajectory in the country is monitored by various expert committees under ICMR, DGHS and other departments.
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Cumulative Covid vaccine doses administered in India cross 137 crore: Health ministry
By PTI
NEW DELHI: The cumulative number of COVID-19 vaccine doses administered in the country crossed 137 crore on Saturday, the Union health ministry said.
More than 69 lakh (69,21,097) vaccine doses were administered till 7 pm on Saturday, it said.
The daily vaccination tally is expected to increase with the compilation of the final reports for the day by late night, the ministry said.
The countrywide vaccination drive was rolled out on January 16 with healthcare workers (HCWs) getting inoculated in the first phase.
ALSO READ | Is Sputnik effective against Omicron? Studies clash on Russian vaccine’s efficacy
The vaccination of frontline workers (FLWs) started from February 2.
The next phase of COVID-19 vaccination commenced from March 1 for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.
The country launched vaccination for all people aged more than 45 years from April 1.
The government then decided to expand its vaccination drive by allowing everyone above 18 years to be vaccinated from May 1.
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Scientists looking into booster dose issue, primary Covid vaccination foremost goal: Government
These interventions and measures are driven by science, local epidemiology and resources, said NITI Aayog Member (Health) V K Paul at a press conference.
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Nearly 136 crore Covid vaccine doses administered in India: Government
The daily vaccination tally is expected to increase with the compilation of the final reports for the day by late night, the Union health ministry said.