The government on Monday issued an advisory for rational use of Remdesivir in COVID-19 treatment, underlining that the anti-viral drug must be advised by senior faculty members directly involved in the patient's care.
As per RDIF, Sputnik V has a number of key advantages, including that there are no strong allergies caused by Sputnik V.
The US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.
'We expect to get the approval in the next few weeks,' says Deepak Sapra, CEO, API and pharmaceutical services, Dr Reddy's Laboratories (DRL).
According to an official statement, the FDA has determined that the Moderna COVID-19 vaccine has met the statutory criteria for issuance of an emergency use authorisation (EUA).
The Central Drugs Standard Control Organisation has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking the number of preventives and treatments available in India to 12.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
In India, itolizumab, known by the brand name Alzumab, has been priced at Rs 8,000 per vial. Most patients require four vials for Covid-19 treatment, taking the cost of the therapy to Rs 32,000.
"We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week," said Rosario, head of the Federal Comptroller General.
A senior health official said the probe will find out how the teenager was given the shot even though the government is yet to roll out any anti-COVID 19 vaccination programme for minors.
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
The Brazilian health regulator's decision comes after the vaccine maker informed the South American country about the termination of its pact with its partners in that country.
The previous single-day record was on May 7 at 2,769 deaths.
But it is not clear when the jabs will arrive in the country as a consensus on the indemnity clause is yet to be reached, sources said.
Pfizer sought to participate in the Subject Expert Committee consultations towards an emergency use authorisation for its Covid-19 vaccine. However, the company representatives have been unable to participate in the meetings because of extremely short notices of a few hours or less and time-zone limitations.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
The Serum Institute of India has stockpiled 40 mn-50 mn doses and is adding more every week. Most of these will come to India.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
By January-February, it's expected to have at least 100 million doses for the Indian government, reports Sohini Das.
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
'WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,' the global health body tweeted.
Biden got a third Pfizer dose after booster doses were approved by federal health officials.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
On when vaccination for children could start as Zydus Cadila's Covid vaccine has been granted emergency use authorisation for those 12-year-old and above, he said children were not being inoculated against COVID-19 on a large scale anywhere in the world though it has been initiated in some countries in a limited manner.
The results were the same in seniors, with a median age of 76, and caregivers, with a median age of 48, and old alike, according to the researchers.
The Congress chief appealed to the prime minister that with restrictions being imposed to stop the spread of the virus, he should put in place a minimum monthly guaranteed income scheme and transfer a sum of Rs 6,000 into every eligible citizen's account.
FDA said as of now it has issued an emergency use authorisation to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
Union Health Minister Mansukh Mandaviya on Tuesday told Bharatiya Janata Party MPs that Covid vaccination for children is likely to start soon, sources said.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
Zydus Cadila has agreed to bring down the price of its COVID-19 vaccine to Rs 265 a dose following persistent negotiations by the government but a final deal is yet to be reached, sources said on Sunday.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said vaccine effectiveness will be seen only after 14 days.
Commercial launch and supply to major government and private hospitals is expected in mid-June.
Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.
The seven states are Bihar, Jharkhand, Maharashtra, Punjab, Tamil Nadu, Uttar Pradesh and West Bengal.
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