3 years, 8 months ago

DCGI refuses to grant emergency-use authorisation to Covid vaccine Sputnik-Light

India's drug regulator has refused to grant emergency-use authorisation to single-dose COVID-19 vaccine Sputnik-Light, while ruling out the need for the conduct of the phase-3 trial of the Russian vaccine in the country. According to the recommendations of the Subject Expert Committee meeting held on July 30, which have been approved by the Drugs Controller General of India, Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial. According to the SEC recommendations, which were uploaded on the Central Drugs Standard Control Organisation website on Thursday, Dr Reddy's Laboratories had submitted a proposal to the DCGI seeking market authorisation of Sputnik-Light, along with the interim safety and efficacy data generated from the phase 1/2 clinical trials in Russia, and presented the protocol for conducting the phase-3 clinical trial of the vaccine in India before the committee. "After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the phase-3 clinical trial of Sputnik-Light that is being carried out in Russia for considering the proposal for the grant of MA in the country.

India Russia Trial Data Covid Sec Vaccine Dcgi Sputnik Efficacy Data emergencyuse sputnik safety authorisation grant data dcgi recommendations refuses generated immunogenicity vaccine phase3 trial covid sputniklight

History of this topic

2 years, 10 months ago

No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court

Live Law

In its judgment holding that the policy of the Union Government on COVID-19 vaccination policy is reasonable, the Supreme Court rejected the contention that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data.The court observed that the challenge to the procedures adopted by the expertbodies while granting. "However, it …

2 years, 10 months ago

1st dose of Sputnik V to be given as booster to those vaccinated with Russian vaccine

India Today

National Technical Advisory Group on Immunisation has given its approval to the first dose of Sputnik Covid-19 vaccine to be administered as a booster dose to all those vaccinated with the Russian vaccine. Two days ago, India Today filed an RTI to find out what was the option for a third dose for those vaccinated with Sputnik V in India. …

3 years ago

Ukraine war: WHO delays review of Russia’s Sputnik V vaccine

Hindustan Times

The World Health Organization has delayed the review of Russia's Covid-19 vaccine Sputnik V as Moscow continues its full-scale attack on Ukraine. A medical specialist holds a vial of Sputnik V vaccine against the coronavirus in a department store in Moscow, Russia Addressing a press conference on Wednesday, WHO vaccines expert Dr Mariangela Simao said, "We were supposed to go …

3 years ago

Govt Panel Recommends Permission for Phase-3 Trial of Covovax as Booster Dose in Adults

News 18

An expert panel of India’s central drug authority has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax as a booster dose in adults, official sources said on Sunday. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation had on Friday recommended giving permission for conducting a phase-3 clinical trial of the single-dose …

3 years ago

COVID 19: Govt panel recommends permission for phase-3 trial of Covovax as booster dose in adults

India TV News

Highlights Govt has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax. An expert panel of India's central drug authority has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax as a booster dose in adults, official sources said on Sunday. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation …

3 years ago

Govt panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose

India Today

An expert panel of India’s central drug authority has recommended permission to conduct a phase-3 clinical trial of the single-dose Covid-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said on Saturday. "The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the …

3 years ago

Covid-19 Vaccine Sputnik V's India Production In A Fix After Sanctions on Russia's Jab Manufacturer

News 18

The sanctions imposed by the United States on the Russian Direct Investment Fund, which markets Sputnik V internationally has raised concerns over the manufacturing of the Covid-19 vaccine in India, the second largest producer of the jab after Russia. RDIF is Russia’s sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and …

3 years, 1 month ago

Omicron variant Updates: Religious places reopen in Bihar's Patna, Covid restrictions relaxed

India TV News

Omicron variant LIVE Updates: With daily COVID-19 cases on the decline, the Jammu and Kashmir State Executive Committee on Sunday ended the weekend lockdown and gave one-hour relaxation in the night curfew timings. Meanwhile, the Drugs Controller General of India has granted emergency use permission to single-dose Sputnik Light Covid vaccine in the country, Union Health Minister Mansukh Mandaviya said …

3 years, 1 month ago

Covid-19 pandemic: India's daily cases drop below 1 lakh after a month; positivity rate dips to 7.25%

India TV News

Highlights India reports 83,876 new Covid cases, 895 deaths in a day India's daily cases drop below 1 lakh after a month The active Covid-19 cases now stand at 11,08,938 India's daily Covid-19 cases dipped below 1 lakh on Monday as the nation reported 83,876 new infections, according to the Union Health Ministry data. This comes following recommendations of an …

3 years, 1 month ago

DCGI grants emergency use permission to Sputnik Light COVID-19 vaccine

Firstpost

Hyderabad-based Dr Reddy’s Laboratories is the Indian partner of the Russian Direct Investment Fund, which has sought approval from the Indian drug regulator for use of single-dose Russia’s Sputnik Light one shot New Delhi: The Drugs Controller General of India has granted emergency-use permission to the single-dose Sputnik Light COVID-19 vaccine, informed Union Health Minister Mansukh Mandaviya on Sunday. “DCGI …

3 years, 1 month ago

Single-dose Sputnik Light Covid vaccine gets approval for emergency use in India

India Today

The Drugs Controller General of India has granted emergency-use permission to the single-dose Sputnik Light COVID-19 vaccine on Sunday. DCGI has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India. — Dr Mansukh Mandaviya February 6, 2022 An expert panel of India's central drug authority on Friday recommended granting restricted emergency use authorisation to the single-dose Covid-19 …

3 years, 1 month ago

Single-dose Sputnik Light Covid vaccine receives emergency use approval from DCGI

India TV News

Single-dose Sputnik Light Covid vaccine receives emergency use approval from DCGI Sputnik Light Covid vaccine is the 9th vaccine to be approved for emergency use in India. Highlights Sputnik Light Covid vaccine received emergency use approval on Sunday. Union Health Minister Mansukh Mandaviya on Sunday notified that the single dose Sputnik Light Covid vaccine has received emergency use permission from …

3 years, 1 month ago

Government panel recommends emergency use authorisation for single-dose COVID-19 jab Sputnik Light

Firstpost

According to Dr Reddy’s Laboratories, the Sputnik Light vaccine is approved in 29 countries, including Argentina, Russia etc New Delhi: An expert panel of India’s central drug authority on 4 February, 2022, recommended granting restricted emergency use authorisation to single-dose COVID-19 vaccine Sputnik Light subject to various regulatory provisions, official sources said. Sputnik Light is the same as component-1 of …

3 years, 1 month ago

Government panel recommends emergency use authorisation for single-dose COVID jab Sputnik Light

India TV News

Government panel recommends emergency use authorisation for single-dose COVID jab Sputnik Light The interim data of the efficacy trial from Russia has shown an efficacy of 65.4 per cent against COVID-19, 21 days after immunisation. Highlights Expert panel of India's central drug authority recommended restricted EUA to COVID vax Sputnik Light Sputnik Light is the same as component-1 of Sputnik …

3 years, 1 month ago

Govt panel recommends granting emergency use authorisation to single dose of Covid vaccine Sputnik Light

India Today

An expert panel of India's central drug authority on Friday recommended granting restricted emergency use authorisation to the single-dose Covid-19 vaccine Sputnik Light, subject to various regulatory provisions, official sources said. Sputnik Light is the same as component-1 of Sputnik V. According to an official source, in light of the recommendations made during an SEC meeting on January 31, Dr …

3 years, 1 month ago

Trying to Bring Sputnik M Vaccine for Adolescents to India: Dr Reddy's

News 18

Dr Reddy’s Laboratories on Friday said it is in discussions with the Indian drug regulator to bring Russia’s Sputnik M, a COVID-19 vaccine for the 12 to18-year-old category, to India. Addressing a press conference after announcing the company’s Q3 results, a senior executive of the drug maker said Phase 3 clinical trial data of Russia’s single dose COVID-19 vaccine Sputnik …

3 years, 2 months ago

Expert panel may approve Sputnik Light vaccine for emergency use, discuss trials nasal vax

India Today

The Subject Expert Committee is slated to hold a meeting to provide emergency use authorisation to Russia’s Sputnik Light, the one-shot Covid vaccine, on Tuesday, sources said. The Gamelaya Institute in Moscow, which made the Russian vaccine, said all individuals who had received a single shot of Sputnik Light booster dose developed neutralising antibodies against the Omicron Covid-19 variant, even …

3 years, 3 months ago

Sputnik V, Sputnik Light Booster Effective Against Omicron, Says RDIF

News 18

Russian Direct Investment Fund on Friday said a preliminary laboratory study conducted by the Gamaleya Center has demonstrated that the Sputnik V vaccine and the one-shot Sputnik Light booster were effective against the Omicron variant of Covid-19. Heterologous boosting with Sputnik Light is the solution to increase other vaccines' efficacy, including against Omicron, and extend the booster protection period, RDIF …

3 years, 3 months ago

Expert Panel To Meet Today To Discuss Covid-19 Booster

ABP News

New Delhi: The Subject Expert Committee will be meeting today to discuss the requirement of a booster shot for high-risk people, reported ANI. The National Technical Advisory Group on Immunization had held a meeting earlier this week to discuss vaccination for children and additional doses. “The meeting put light on COVID-19 vaccination, additional doses, and vaccination for children but due …

3 years, 4 months ago

Sputnik light COVID vaccine to be launched in India by December

India TV News

Sputnik light COVID vaccine to be launched in India by December Russia's Health Ministry will register the Sputnik vaccine for children aged 12-17 on Wednesday, with shots expected to be available at the end of December. Dr Reddy’s Laboratories is the sole distributor of Sputnik V. Russian Direct Investment Fund CEO, Kirill Dmitriev on Wednesday said that the Sputnik light …

3 years, 4 months ago

What Went Wrong with Full Rollout of Russia’s Sputnik V Vaccine in India

News 18

Slower than anticipated production of the second dose of Sputnik V, heavy cold storage requirements, pending WHO approval, rising Covid-19 cases in Russia and low demand at private hospitals have put brakes on the complete rollout of the Russian vaccine in India. It means that only one second dose is manufactured for every 5 first doses manufactured.” According to experts …

3 years, 4 months ago

In Russia, 83% of COVID hospital beds are filled amid surge

Associated Press

MOSCOW — Nearly 83% of hospital beds designated for COVID-19 patients are filled, Russian authorities said Wednesday, as daily tallies of new infections and deaths remain at all-time highs. Russia’s autumn surge in infections and deaths comes amid low vaccination rates, lax public attitudes toward taking precautions and the government’s reluctance to toughen restrictions. In total, Russia’s state coronavirus task …

3 years, 4 months ago

Sputnik V Developer Calls for Mandatory Covid-19 Vaccines in Russia as Inoculation Remains Low

News 18

The developer of Russia’s coronavirus vaccine Sputnik V has said Moscow should make jabs mandatory as inoculation rates remain low despite record deaths and campaigning by authorities. Gintsburg said Russia was currently working on developing a nasal vaccine that would “complement” Sputnik V. He said Moscow was also carrying out tests of a version of the Sputnik vaccine for minors. …

3 years, 4 months ago

Kremlin Says Sputnik Light is a Valid Standalone Vaccine, Not Just Booster

News 18

The Kremlin insisted on Monday that Russian-developed Sputnik Light was a standalone COVID-19 vaccine, after Russia’s health minister was quoted as saying it would be used only as a booster for people who have already been inoculated. Russia had previously promoted Sputnik Light, which comprises the first shot of its flagship two-shot Sputnik V, as an effective standalone vaccine as …

3 years, 4 months ago

Dr Reddy's Expected to Submit Sputnik V Light Trial Data to DCGI in November

News 18

Dr Reddy's Laboratories Ltd is expected to submit Phase 3 trials data of single dose Russian COVID-19 vaccine Sputnik Light to the Indian drug regulator next month, even as the city-based firm is getting ready to conduct trials of the jab in 2 to 18 year old children in two cohorts. Deepak Sapra CEO API and Services Dr. Reddy's said …

3 years, 4 months ago

Serum Institute seeks DCGI nod for Covid vaccine Covovax

India Today

The Serum Institute of India on Friday sought permission from the Drugs Controller General of India to manufacture Covid-19 vaccine Covovax for restricted use in emergency situations at its Manjari manufacturing site, official sources said. There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government …

3 years, 5 months ago

Namibia halts use of Sputnik jabs after South Africa HIV fears

New Indian Express

Neighbouring South Africa earlier this week said it would not approve Sputnik V due to concerns it could increase the risk of HIV infection among men, a claim the vaccine's developer says is unfounded. South Africa's health products regulator on Monday said it would not authorise use of Sputnik based on earlier studies testing the safety of a modified form …

3 years, 5 months ago

Russia, WHO differ on when approval will come for Sputnik V

Associated Press

MOSCOW — Russia is ready to provide up to 300 million doses of its Sputnik V vaccine to the U.N.-backed COVAX initiative, a top Russian official promoting the shot says, even though the World Health Organization hasn’t yet signed off on it and production issues have fanned customers’ concerns worldwide. She said the approval process for Sputnik V is currently …

3 years, 5 months ago

One-shot Sputnik Light Vaccine Shows 70% Efficacy Against Covid Delta Variant: RDIF

News 18

The Russian Direct Investment Fund and Gamaleya Center on Wednesday said one-shot Sputnik Light vaccine demonstrates 70 per cent efficacy against infection with the Delta variant of coronavirus during the first three months after vaccination. Gamaleya Center has submitted an article analysing efficacy of Sputnik Light vaccine against the Delta variant to the medRxiv preprint server for health sciences, RDIF …

3 years, 5 months ago

WHO says approval for Russia’s Sputnik V vaccine ‘still on hold’

Al Jazeera

The World Health Organization has said the Emergency Use Listing process for Russia’s Sputnik V COVID-19 vaccine was on hold pending some missing data and legal procedures, which the UN body hopes will be “sorted out quite soon”. Sputnik Light vaccine Meanwhile, the Russian Direct Investment Fund on Wednesday said the one-shot Sputnik Light vaccine, citing its developer, showed 70 …

3 years, 5 months ago

Centre permits export of 40 lakh doses of Covid-19 vaccine Sputnik Light manufactured in India to Russia

India Today

The government has permitted the export of Russia's single-dose Covid-19 vaccine Sputnik Light domestically produced as the jab has not yet been approved for emergency use in India, sources said on Sunday. Sputnik Light is the same as component-1 of the Russian vaccine Sputnik V, which is being used in India's anti-Covid inoculation programme after getting emergency use authorisation from …

3 years, 5 months ago

Centre allows export of Russian Sputnik Light Covid-19 vaccine made in India

India TV News

Centre allows export of Russian Sputnik Light Covid-19 vaccine made in India Sputnik Light is the same as component-1 of the Russian vaccine Sputnik V which is being used in India's anti-COVID inoculation programme after getting emergency use authorisation from India's Drug Regulator in April. The government has permitted the export of Russia's single-dose COVID-19 vaccine Sputnik Light domestically produced …

3 years, 5 months ago

India Allows Export of Russia’s Sputnik Light Covid Jab Produced by Hyderabad’s Hetero Biopharma

News 18

The government has permitted the export of Russia’s single-dose COVID-19 vaccine Sputnik Light domestically produced here, Sputnik V confirmed on Sunday. Sputnik Light is the same as component-1 of the Russian vaccine Sputnik V which is being used in India’s anti-COVID inoculation programme after getting emergency use authorisation from India’s Drug Regulator in April. The Russian ambassador had urged the …

3 years, 5 months ago

Govt allows export of Russia’s Sputnik Light Covid-19 vaccine made in India

Live Mint

New Delhi: The government has permitted the export of Russia's single-dose COVID-19 vaccine Sputnik Light domestically produced here as the jab has not yet been approved for emergency use in India, sources said on Sunday. Sputnik Light is the same as component-1 of the Russian vaccine Sputnik V which is being used in India's anti-COVID inoculation programme after getting emergency …

3 years, 5 months ago

Russians flock to Serbia for Western-made COVID-19 vaccines

The Independent

For free real time breaking news alerts sent straight to your inbox sign up to our breaking news emails Sign up to our free breaking news emails Sign up to our free breaking news emails SIGN UP I would like to be emailed about offers, events and updates from The Independent. “We took the Pfizer vaccine because we want to …

3 years, 5 months ago

Data on Russia's Sputnik V vaccine is still under review for emergency use approval: WHO

Firstpost

The World Health Organization is still reviewing data about Russia’s Sputnik V vaccine as part of hopes that it can be approved by the U.N. health agency for emergency use against coronavirus, but said Tuesday that no decision is imminent. The clarification comes after Russian Health Minister Mikhail Murashko in recent days said that administrative issues were among the main …

3 years, 5 months ago

WHO still reviewing Sputnik V vaccine, as Russia presses bid

Associated Press

GENEVA — The World Health Organization is still reviewing data about Russia’s Sputnik V vaccine as part of hopes that it can be approved by the U.N. health agency for emergency use against coronavirus, but said Tuesday that no decision is imminent. The clarification comes after Russian Health Minister Mikhail Murashko in recent days said that administrative issues were among …

3 years, 5 months ago

WHO Still Reviewing Sputnik V Vaccine For Emergency Use As Russia Presses Bid

News 18

The World Health Organization is still reviewing data about Russias Sputnik V vaccine as part of hopes that it can be approved by the U.N. health agency for emergency use against coronavirus, but said Tuesday that no decision is imminent. The clarification comes after Russias Health Minister Mikhail Murashko in recent days reportedly said that administrative issues were among the …

3 years, 5 months ago

WHO still reviewing Sputnik V vaccine, as Russia presses bid

India TV News

WHO still reviewing Sputnik V vaccine, as Russia presses bid The World Health Organisation is still reviewing data about Russia's Sputnik V vaccine as part of hopes that it can be approved by the UN health agency for emergency use against coronavirus, but said Tuesday that no decision is imminent. The World Health Organisation is still reviewing data about Russia's …

3 years, 6 months ago

India likely to allow export of Sputnik Light COVID shot this month: Report

Live Mint

New Delhi: India is likely to allow the export of domestically produced doses of Russia's Sputnik Light COVID-19 vaccine this month, as the shot has yet to be approved in India, two sources with knowledge of the matter told Reuters. Local media have reported that Indian drugmaker Hetero has already manufactured 2 million doses of the single-shot vaccine, for whose …

3 years, 6 months ago

Russia seeks Indian government's nod for export of Sputnik Light COVID-19 vaccine

Firstpost

Over the past months, the Russian Direct Investment Fund has been working closely with Indian pharmaceutical companies to ramp up the production of the Sputnik vaccine in India New Delhi: The Russian ambassador has urged the Indian government to allow the export of single-dose COVID-19 vaccine Sputnik Light produced by Hetero Biopharma, one of the RDIF’s partners in the production …

3 years, 6 months ago

Sputnik Light, J&J take another step towards joining India's COVID vaccine arsenal

Firstpost

While Sputnik Light has received DCGI’s approval for phase-3 bridging trials, around 35 lakh doses of J&J’s vaccine have been dispatched for final round of quality and safety checks in HP In an affidavit dated 26 June, the Centre had told the Supreme Court that a total of 135 crore doses of COVID-19 vaccines will be made available to the …

3 years, 6 months ago

Sputnik's single-dose vaccine gets DCGI nod for phase-III trials in India

India TV News

Sputnik's single-dose vaccine gets DCGI nod for phase-III trials in India CDSCO in July had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country. The nod comes after a recent study published in the medical journal The Lancet said that Sputnik Light showed …

3 years, 6 months ago

Dr Reddy’s Labs gets approval for phase 3 trials of Sputnik Light in India

Hindustan Times

India’s drugs regulator has granted permission to Dr Reddy’s Laboratories to conduct phase 3 clinical trials for Sputnik Light, the single dose and first component of the Russian made Sputnik V vaccine against Coronavirus disease. The subject expert committee of the Central Drugs Standard Control Organisation, in its 172nd meeting last month, recommended the drugs controller to grant approval to …

3 years, 6 months ago

India to Begin Testing Russia’s Single-Shot Sputnik Light Shortly, 1st Tranche Sent for Quality Testing

News 18

As India gears up to kick-start the bridging trial of Russia’s single-shot vaccine, Sputnik Light, the first tranche has been sent for quality and safety validation, News18.com has learnt. “While samples of Sputnik Light, manufactured by domestic pharma company Panacea Biotec, have already been sent for quality, safety checks at the Central Drugs Laboratory in Kasauli, the hospitals have also …

3 years, 6 months ago

Covid-19 Vaccine: Dr Reddy's Starts Supply of Sputnik V First Doses

News 18

Dr Reddy’s Laboratories on Tuesday said it initiated supply of the first dose component of Russian Covid-19 vaccine Sputnik V to partner hospitals all over the country. A Dr Reddy’s spokesperson also said the supply of the first does is followed by equivalent quantities of the second dose component. Dr. Reddy’s has initiated supply of the first dose component to …

3 years, 6 months ago

DCGI nod to phase-I clinical trial of COVID-19 vaccine of Reliance Life Sciences

The Hindu

The Drugs Controller General of India on September 3 granted permission to the Mukesh Ambani-owned Reliance Life Sciences to conduct phase-I clinical trial of its indigenous COVID-19 vaccine with certain conditions, sources said. The phase-I clinical trial will be conducted to evaluate safety, tolerability and immunogenicity of the SARS-CoV-2 recombinant protein subunit vaccine in healthy volunteers according to protocol, they …

3 years, 7 months ago

Sputnik V and AstraZeneca vaccine cocktail shows positive results in early trials

India Today

A combination of the AstraZeneca vaccine and the first component of the Sputnik V vaccine has shown high immunogenicity profile in a clinical study conducted in Azerbaijan. The Russian Direct Investment Fund, Russia’s sovereign wealth fund, AstraZeneca and R-Pharm have announced the preliminary results of immunogenicity of the combined use of the two vaccines. The heterogeneous boosting approach or ‘vaccine …

3 years, 7 months ago

Single-dose Sputnik Light vaccine set for launch in September, likely to be priced at Rs 750: Report

India TV News

Single-dose Sputnik Light vaccine set for launch in September, likely to be priced at Rs 750: Report Panacea Biotec has partnered Russian Direct Investment Fund to launch the Russian Sputnik V vaccine in India. Panacea Biotec has partnered Russian Direct Investment Fund to launch the Russian Sputnik V vaccine in India. According to RDIF, Sputnik Light vaccine can be effectively …

3 years, 7 months ago

Sputnik V hits production roadblock for second dose of Covid vaccine | Exclusive

India Today

Russia’s Sputnik V has reportedly hit a roadblock in the development of the second dose of its Covid-19 vaccine in India. "Production in India is expected to come fully onstream in September and RDIF expects India to become a major production hub for the Sputnik V vaccine with such companies as Serum Institute of India, the world’s biggest vaccine producer, …

Discover Related

2 weeks, 1 day ago

'Covid-19 Has Subsided And Vaccines Have Become Unnecessary Today': Karnataka High Court Disposes Man's Plea For Second Dose

Live Law

The Karnataka High Court on Monday disposed of a 2022 petition filed by one Vinod Kumar M N seeking a direction to the authorities to give him a second dose of Covid vaccine. A single judge, Justice M Nagaprasanna said “The petitioner is before this court seeking a direction for a second dose of covid vaccine, the covid-19 has subsided …

Covid Kar Vaccine Second Dose Unnecessary Today

1 month ago

DCGI seeks post-market surveillance data on 2 combination drugs within 3 months

Live Mint

Drugs Controller General of India has sought active post-market surveillance data from the drugmakers of two fixed-dose combination medicines—Imipramine Hydrochloride IP + Diazepam IP tablets used to ease co-morbid anxiety conditions, and Chlorphenamine Maleate IP + Ammonia Chloride IP + Sodium Citrate IP syrup used to relieve cough and respiratory distress. “Manufacturers who are already holding licences from State Licensing …

Dcgi Fdc Combination Drug

1 month, 1 week ago

What is the cancer vaccine Russia is offering? | Explained

The Hindu

The story so far: In December last year, Russia announced that it had developed a new, mRNA-based personalised ‘vaccine’ for cancer which would be available free for patients by early 2025. Unlike, say, the COVID-19 mRNA vaccine that targets one antigen — the spike protein of the coronavirus, the cancer mRNA ‘vaccines’ may also be designed to target multiple antigens. …

Cancer Russia Treatment Chennai Vaccines Immune Cancer Cells

1 month, 2 weeks ago

Stray Dogs Being Microchipped To Avoid Vaccine Duplication: BBMP Tells Karnataka HC, Court Declines To Stay Chip Implant Proposal

Live Law

The Karnataka High Court on Monday refused to stay the Request for Proposal floated by Bruhat Bengaluru Mahanagara Palike for procuring and implanting microchip readers in the bodies of stray dogs in the city. Counsel for the corporation submitted that “Microchipping of stray dogs in Bengaluru is being done so that vaccination is not duplicated. Therefore as a pilot project …

Court Petition Stray Dogs Bbmp Microchip

1 month, 2 weeks ago

GP who plotted to sell fake Covid vaccination certificates for patients who had not had the jab is banned for 12 months

Daily Mail

A GP who tried to draw colleagues into a scheme to provide fake Covid vaccination certificates has been suspended for a year by a healthcare watchdog. Dr Sonali Mukherjee-Bose, 54, promised a junior colleague more money for a 'couple of hours' work than he would make in a month if she went along with her scheme in October 2021. Dr …

Work Fake Covid Told Certificates Colleague

2 months, 1 week ago

'Just nuts': Health experts 'appalled' by RFK's reported Covid-era request

Raw Story

As thousands of Americans were still dying weekly from the COVID-19 pandemic, Robert F. Kennedy Jr., President-elect Donald Trump’s pick to run the Department of Health and Human Services, made a formal request to the Food and Drug Administration in May 2021 demanding that officials halt all Covid vaccines, according to a new report. And with Kennedy set to lead …

Health Public Health Trump Vaccines Kennedy Public Covid

Clinical trials of medicines often done in poor countries: Supreme Court

The Hindu

Observing clinical trials of medicines and vaccines were often carried out in poor countries, the Supreme Court on Wednesday allowed a petitioner to file submissions and objections to the rules framed by the Centre on the issue. A bench comprising Justices Hrishikesh Roy and S.V.N Bhatti considered the submissions of Centre's Additional Solicitor General Archana Pathak Dave who said rules …

India Trials Clinical Trials Rules Centre Pil Dave

2 months, 3 weeks ago

Mixed lessons from intentionally infecting people with COVID-19

Salon

When the Covid-19 pandemic first struck, Christopher Chiu and other researchers wondered: Should they inject healthy people with the virus that caused the pandemic? “With these challenge studies, you can really control for all of this and that makes them very, very unique.” In recent decades, challenge trials have become more scientifically rigorous but have continued to spark ethical concerns …

Disease Trials Long Covid Covid Infection Virus Study

3 months ago

Letters to the Editor: I’m a polio survivor. RFK Jr. shouldn’t have say in the nation’s health policies

LA Times

To the editor: I am a survivor of bulbar polio; I contracted it when I was 5 years old in 1946. I knew my children and countless others would never face what I went through, or face death or an iron lung. I can’t describe how angry I was to find out that an advisor to Robert Kennedy Jr. is …

Polio

Serum Institute to manufacture Mpox vaccine by Danish maker Bavarian Nordic

Hindustan Times

Pune-based Serum Institute of India will be manufacturing Danish vaccine company Bavarian Nordic’s vaccine against mpox— MVA-BN— locally for the Indian market, according to latter’s statement issued on Monday on the license and manufacturing agreement signed between the two companies. “… Under the agreement, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN® to SII …

Global India Manufacturing Mpox Mva Danish Bavarian Nordic

3 months, 1 week ago

Congo to get Japan's mpox vaccine for children from next week, Africa CDC says

Hindustan Times

DAKAR, - Democratic Republic of Congo should start to receive three million doses of mpox vaccine from Japan next week that can be used on children, the Africa Centres for Disease Control and Prevention said on Thursday. Congo to get Japan's mpox vaccine for children from next week, Africa CDC says Vaccinations against the potentially deadly infection are under way …

Children Africa Japan Mpox Cdc Next Week Vaccine

3 months, 2 weeks ago

‘CDSCO waives local clinical trials for new drugs approved in the US’

The Hindu

All new drugs are approved by the Central Drugs Standard Control Organization without local clinical trials on case to case basis in consultation with Subject Expert Committee, Union Health Minister Anupriya Patel informed in response to question from Tirupati MP Maddila Gurumoorthy on Friday. The MP asked whether the Union Health Ministry has decided to waive the requirement of clinical …

Drugs Trials Clinical Trials Cdsco Clinical Union Health New Drugs

3 months, 2 weeks ago

Britain needs a ‘vaccine taskforce’ to prepare for the next pandemic, Lords warn

The Independent

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email Get our free Health Check email SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy Britain needs a “peacetime vaccine task force” to prepare for the …

Health Check Vaccine

4 months ago

UN authorizes first mpox vaccine for children in an attempt to control Congo outbreak

Associated Press

GENEVA — The World Health Organization has authorized the first mpox vaccine for children, a decision experts hope will help make immunizations more widely available to one of the hardest-hit populations during the ongoing outbreaks of the disease in Congo and elsewhere in Africa. In a statement late Tuesday, the U.N. health agency said it had approved the mpox vaccine …

Children Cases Mpox Congo

4 months, 1 week ago

PopVax Announces that the U.S. National Institute of Allergy and Infectious Diseases will Conduct and Sponsor the U.S.-based Phase I Clinical Trial of PopVax’s Next-Generation mRNA-LNP COVID-19 Vaccin

Live Mint

MUMBAI, India & HYDERABAD, India – Business Wire India PopVax, an Indian full-stack biotechnology company developing novel mRNA vaccines and therapeutics using machine learning-enabled computational protein design, is pleased to announce that it has been selected for inclusion in the U.S. Government’s Project NextGen. As part of this initiative, the National Institute of Allergy and Infectious Diseases, part of the …

Hyderabad Infectious Diseases Candidate Vaccine Mrna Niaid Project Nextgen

4 months, 1 week ago

First bivalent mRNA vaccine candidate against RSV goes under clinical trial

China Daily

The world's first bivalent mRNA vaccine candidate against respiratory syncytial virus, or RSV, kicked off Phase I clinical trial in China on Wednesday, as an adult received a shot at a clinical research center of a major Shanghai hospital. "Official figures showed that RSV caused more than 80 percent of respiratory viral infection cases in infants and young children in …

Candidate Clinical Clinical Trial Rsv Vaccine Bivalent Mrna Innorna

4 months, 2 weeks ago

Health Talk | How eliminating polio has been one of the major successes of India's Universal Immunisation Programme

Hindustan Times

The World Immunisation Day is observed every year on November 10th. India is a classic example of what robust immunisation coverage against a disease can achieve in the form of the country's pulse polio programme, of which vaccination was a crucial part. India rolled out the Pulse Polio Immunization Programme on October 2 1994, and according to WHO India statement, …

Health India Disease Vaccines Immunisation Programme Diseases

4 months, 2 weeks ago

Vaccine doses allocated for nine African countries hardest hit by mpox

The Hindu

An initial 899,000 vaccine doses have been allocated for 9 countries across Africa that have been hit hard by the current mpox surge, the WHO and other health organisations said on Wednesday. The WHO declared mpox a global public health emergency for the second time in two years in August after a new variant of the virus, called clade Ib, …

Mpox Countries Vaccine

4 months, 3 weeks ago

India to undertake mega study of covid-19 samples to help prepare for future pandemics

Live Mint

New Delhi: The Department of Biotechnology plans to undertake a study of thousands of samples and clinical material collected during covid-19 to help Indian scientists understand the susceptibility of individuals and changes in metabolic activity that will be useful in fighting future pandemics. The department will give the Indian SARS-CoV-2 Genomics Consortium, a consortium of 54 laboratories, the mandate to …

India Indian Official Covid Studies Dbt Future Pandemics

4 months, 3 weeks ago

Norovirus vaccine: What is it, when could it be available and will it be on the NHS?

The Independent

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email Please enter a valid email address Please enter a valid email address SIGN UP I would like to be emailed about offers, events and updates from The Independent. Please try again later {{ /verifyErrors }} With norovirus …

Health Trial Norovirus Email Nhs Health Check Vaccine

5 months ago

Global Pandemic Threat: 100 Days to Save Lives

Hindustan Times

A modelling study suggests that if a vaccine for SARS-CoV-2 had been developed within 100 days, an estimated 8.3 million deaths could have been averted globally. The study also estimated that productivity losses due to illness amounting to almost $1.4 trillion and $63 billion of hospitalisation costs would have been averted globally.

Government Science Law Health Talk

5 months ago

Covid vaccine: How to book a jab and who is eligible?

The Independent

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email Please enter a valid email address Please enter a valid email address SIGN UP I would like to be emailed about offers, events and updates from The Independent. UKHSA figures showed the admission rate for patients testing …

Health Email Nhs Health Check Vaccine Ukhsa Covid Vaccine

5 months, 2 weeks ago

Congo finally begins mpox vaccinations in drive to slow outbreaks declared a global emergency

The Independent

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Mpox Email Congo Workers Health Slow Outbreaks

5 months, 3 weeks ago

Congo begins mpox vaccinations two months after global emergency is declared

LA Times

Congolese authorities on Saturday began vaccination against mpox, nearly two months after the disease outbreak that spread from Congo to several African countries and beyond was declared a global emergency by the World Health Organization. Mpox had been spreading mostly undetected for years in Africa before the disease prompted the 2022 global outbreak that saw wealthy countries quickly respond with …

Africa Mpox Congo Global Emergency Deaths Recorded

6 months ago

Rwanda begins vaccinations against mpox amid a call for more doses for Africa

The Independent

Africa Rwanda Vaccine Congo Doses Countries Kaseya

6 months, 1 week ago

Global vaccine alliance GAVI to buy 500,000 doses of mpox vaccine

Associated Press

DAKAR, Senegal — The global vaccine alliance Gavi will buy 500,000 doses of mpox vaccine to battle outbreaks of the disease in African countries, the organization said on Wednesday. Since the beginning of the year, there have been over 25,000 confirmed mpox cases and 723 related deaths, the vast majority in Congo, and the World Health Organization declared it a …

Mpox Congo Doses Global Vaccine Gavi

6 months, 1 week ago

Global vaccine alliance GAVI to buy 500,000 doses of mpox vaccine

The Independent

Mpox Congo Doses Global Vaccine Gavi

6 months, 1 week ago

WHO grants first mpox vaccine approval to ramp up response to disease in Africa

Associated Press

GENEVA — The World Health Organization said Friday it has granted its first authorization for use of a vaccine against mpox in adults, calling it an important step toward fighting the disease in Africa. “This first of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in …

Africa Mpox Vaccine

6 months, 1 week ago

World Health Organization approves Bavarian Nordic's mpox vaccine, clearing the way for heightened response in Africa

ABC

The World Health Organization says it has cleared Bavarian Nordic's mpox vaccine, the first such vaccine to be approved by the agency for containing the spread of the disease in badly hit African countries. Bavarian Nordic's vaccine has been used worldwide since 2022, after US and European regulators backed it for use against a different strain of mpox that spread …

Mpox Vaccine Bavarian Nordic

6 months, 2 weeks ago

Chinese mpox vaccine to undergo clinical trial

China Daily

China Daily| Updated :2024-09-11 The country's top drug regulator has cleared a mpox vaccine developed by Chinese drugmaker Sinopharm for clinical trial on Monday, which could be the nation's first experimental dose to battle the deadly disease, according to the company. The domestic vaccine candidate, created by the Shanghai Institute of Biological Products and administered by Sinopharm, is expected to …

China Mpox Vaccine Clinical Trial

6 months, 2 weeks ago

Chinese mpox vaccine to undergo clinical trial

China Daily

The country's top drug regulator has cleared a mpox vaccine developed by Chinese drugmaker Sinopharm for clinical trial on Monday, which could be the nation's first experimental dose to battle the deadly disease, according to the company. The domestic vaccine candidate, created by the Shanghai Institute of Biological Products and administered by Sinopharm, is expected to play an important role …

China Mpox Vaccine Clinical Trial

6 months, 2 weeks ago

Raipur Diary: New biomarkers to predict Covid severity

New Indian Express

In a breakthrough, the scientists of the Multi-Disciplinary Research Unit in Dr Bhimrao Ambedkar Hospital, Raipur, have introduced the country’s first-ever biomarker kit that could provide early-stage severity assessment of COVID-19. Interest-free loans in Maoist-affected districts Besides the ongoing aggressive anti-Maoist operations, the state government decided to offer interest-free loans for technical and professional courses pursued by economically weaker students …

Congress Chhattisgarh

$The first 100,000 doses of mpox vaccine reach Congo. But it’s a fraction of what is needed$

6 months, 2 weeks ago

The first 100,000 doses of mpox vaccine reach Congo. But it’s a fraction of what is needed

The Hindu

The first batch of mpox vaccine arrived in Congo’s capital on Thursday, September 5, 2024, the country’s authorities said, three weeks after the World Health Organization declared mpox outbreaks in 12 African countries a global emergency. About 380,000 doses of mpox vaccines have been promised by Western partners such as the European Union and the United States, Dr. Jean Kaseya, …

Health Africa Nigeria Outbreak Congo Doses Mpox Vaccines

$The first 100,000 doses of mpox vaccine reach Congo. But it’s a fraction of what is needed$

6 months, 2 weeks ago

The first 100,000 doses of mpox vaccine reach Congo. But it’s a fraction of what is needed

Associated Press

KINSHASA, Congo — The first batch of mpox vaccine arrived in Congo’s capital on Thursday, the country’s authorities said, three weeks after the World Health Organization declared mpox outbreaks in 12 African countries a global emergency. The 100,000 doses of the MVA-BN vaccine, manufactured by the Danish company Bavarian Nordic, have been donated by the European Union through HERA, the …

Mpox Congo Mpox Vaccine

6 months, 3 weeks ago

New COVID-19 vaccines targeting JN.1 variant under review by Therapeutic Goods Administration

ABC

Australia's national drug regulator is evaluating the safety and efficacy of two new COVID-19 vaccines designed to provide better protection against new variants of the virus. While there is no longer much circulation of the original JN.1 variant in Australia, Professor Esterman said the new vaccines — targeting JN.1 — would likely still prove highly effective. While TGA approval isn't …

Vaccines Covid Months Vaccine Bennett Booster Tga

6 months, 3 weeks ago

Phase-3 clinical trial of India's first dengue vaccine begins at KIMS-Bhubaneswar

New Indian Express

BHUBANESWAR: The phase-3 clinical trial for India's first Indigenous dengue vaccine, ‘DengiAll,’ commenced at the Kalinga Institute of Medical Sciences on Tuesday. This trial aims to evaluate the efficacy of the Indigenous tetravalent dengue vaccine developed by Panacea Biotec in collaboration with the Indian Council of Medical Research. The tetravalent dengue vaccine, originally developed by the National Institutes of Health, …

India Dengue Bhubaneswar Kims Phase Trial Vaccine Begins

6 months, 3 weeks ago

UNICEF issues emergency tender to secure mpox vaccines with Africa CDC, Gavi and WHO

The Hindu

The United Nations Children's Fund has issued an emergency tender to secure mpox vaccines for crisis-hit countries in collaboration with the Gavi vaccine alliance, Africa CDC and the World Health Organization, the organizations said in a joint statement on Saturday, August 31, 2024. Under the tender, UNICEF will set up conditional supply agreements with vaccine manufacturers, the statement said. Earlier …

Unicef Mpox Vaccine Cdc Gavi

6 months, 3 weeks ago

The number of Covid vaccine skeptics is only growing in America, survey finds

The Independent

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email Get our free Health Check email SIGN UP I would like to be emailed about offers, events and updates from The Independent. Read our privacy policy Covid vaccine misinformation is spreading among Americans, according to a national …

Vaccines Survey Covid Health Check Vaccine Covid Vaccines

6 months, 3 weeks ago

‘Most people are confused’: What to know about the latest Covid shot

Politico

Even the Democratic National Convention turned into a superspreader event. And despite the virus’ prevalence — and the persistent threat of long Covid — public health officials are contending with a myriad of obstacles as they try to boost the population’s defenses, including dwindling enthusiasm for the shots, lackluster testing and the end of a program meant to help the …

Health Covid Cdc Public Health Officials Vaccine Program

7 months ago

Ramping up contact tracing, availability of jab key to curb monkeypox: Dr Javier Guzman

Hindustan Times

The surge in mpox, or monkeypox, cases in parts of Africa has led to the World Health Organization declaring the outbreak of the viral disease a public health emergency of international concern on August 14. Dr Javier Guzman, director of Global Health Policy at the Center for Global Development, in an interview with Rhythma Kaul, discusses how the West should …

Health Outbreak Mpox Vaccines Countries Response International Concern

7 months ago

WHO caused delay in availability of Mpox vaccines in Congo

New Indian Express

There are no vaccines for mpox available in the Democratic Republic of Congo, the epicenter of a global health emergency declared last week, even though the country first asked for the shots two years ago and the manufacturers say they have supplies, The New York Times reported. Three years after the last worldwide mpox outbreak, the WHO still has neither …

Mpox Congo

7 months ago

Congo reports more than 1,000 new mpox cases in a week. African authorities ask for vaccines

Associated Press

CAPE TOWN, South Africa — Congo reported more than 1,000 new mpox cases in the last week up to Tuesday as African health authorities asked for desperately needed vaccines to help fight its “growing” threat on the continent. While mpox has been reported in 12 of Africa’s 54 countries during these outbreaks, the vast central African nation of Congo has …

Cases Vaccines Countries African Cdc Vaccine Congo

7 months ago

COVID-19 variant KP.3.1.1 predominant in US as infections continue ticking up

China Daily

LOS ANGELES - The KP.3.1.1 COVID-19 variant, now the predominant SARS-CoV-2 variant circulating in the United States, has been causing increasing infections in the country, the latest data from the US Centers for Disease Control and Prevention showed. For the two-week period ending Aug 17, KP.3.1.1 is predicted to account for between 31 percent and 43 percent of COVID-19 clinical …

Cdc Period Ending

7 months, 2 weeks ago

Health Talk | Why India waiving off local clinical trials for globally approved new drugs is good news

Hindustan Times

On August 7, India’s drugs regulatory agency, Central Drugs Standard Control Organisation, issued an order that allowed waiving off local clinical trials for approval of certain categories of new and novel drugs in the Indian market that have already been approved for use globally by regulators of countries that follow strict quality control. Local clinical trials or bridging studies as …

India Japan Drugs Drug Approved New Drugs Local Clinical Trials

7 months, 2 weeks ago

Clinical trial: Government announces waiver for several drugs approved from select countries

The Hindu

In a decision that would make drugs manufactured outside India more accessible and affordable in the local market the Central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union. “Drugs including vaccines that fall in the category -- orphan drugs …

India Trial Drugs Access Central Clinical Clinical Trial

7 months, 2 weeks ago

Supreme Court Dismisses Plea To Publish Clinical Trial Data Of Rotavac Vaccine

Live Law

The Supreme Court on Tuesday dismissed a PIL seeking publication of the segregated date of the clinical trial of the vaccine Rotavac administered to infants to protect against diarrhoea.A bench comprising Justices BR Gavai and KV Viswanathan observed that the Court cannot sit in appeal over the decision taken by the expert committee of the National Technical Advisory. The Supreme …

Supreme Court Court Pil Clinical Trial Vaccine Rotavac

7 months, 3 weeks ago

The right way to counter a poor Covaxin safety study

The Hindu

It took all of five days for the Indian Council of Medical Research to strongly criticise the poor design of the long-term safety study of Covaxin by researchers from the Banaras Hindu University, Varanasi. A publication failure that is glaring Three years after the interim data were posted as a preprint, Bharat Biotech and ICMR are yet to publish any …

Trial Study Vaccine Participants Clinical Icmr Bhu

8 months, 1 week ago

‘Still not over’: WHO cautions of COVID-19 threat ahead of summer holidays after US President Joe Biden tests positive

Live Mint

New Delhi: With US President Joe Biden testing positive for COVID-19 before the Presidential elections, the World Health Organisation has warned the public that Covid is still not over. WHO director-general Tedros Adhanom Ghebreyesus issued a warning, stating that vaccination rates among health professionals and the over-60s—two demographics most at risk of dying from COVID—are alarmingly falling. Globally, 9.8 million …

Covid Tedros

8 months, 3 weeks ago

As COVID-19 ticks up in some places, US advisers recommend a fall vaccination campaign

The Independent

Month Officials Cdc Americans Health Officials Last Month

9 months, 2 weeks ago

FDA advisers urge targeting JN.1 strain in recipe for fall's COVID vaccines

The Independent

Fall Covid Fda Vaccine Moderna Pfizer