An expert panel of India's Central Drug Authority on Tuesday recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covid vaccine Covovax on children aged 2 to 17 years with certain conditions, official sources said.
A second wave of Covid driven by the Delta variant engulfed the country in May-June bringing the health system to its knees and leaving people gasping for help.
"The Indian Medical Association has requested all its 3.5 lakh members in 1,800 local branches to voluntarily come out to get vaccinated first to show the world that these vaccines are safe and efficacious," it said.
After healthcare and frontline workers, priority will be given to those above 50 years of age and the under-50 population groups with co-morbidities numbering around 27 crore, it added.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
The EUA allows for Remdesivir to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe condition.
On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
While the Indian government has been procuring Covid-19 vaccines at low prices so far, manufacturers have to declare the prices of vaccines they would supply to the open market (industries, private hospitals, etc) and state governments before May 1. Sohini Das reports.
Cautioning that the country is passing through a phase when there are festivals and potential gatherings, he said this is a critical phase as the virus can spread again.
The highest number of vaccines were administered in UP at 21,291 followed by Andhra Pradesh at 18,412, Maharashtra at 18,328, Bihar at 18,169, Odisha at 13,746, Karnataka at 13,594, Gujarat at 10,787, Rajasthan at 9,279, West Bengal at 9,730, Madhya Pradesh at 9,219, Kerala at 8,062.
In a letter to all states and Union territories, the ministry highlighted that under the emergency use authorisation, coronavirus vaccination is indicated only for 18 years and above. If required, COVID-19 vaccine and other vaccines should be separated by an interval of at least 14 days.
As India prepares to launch its vaccine drive on January 16, here is a look at the options:
An important focus of the dry run will be on management of any possible adverse events following immunisation.
Prime Minister Narendra Modi said on Wednesday that international travel should be made easier through mutual recognition of vaccine certificates, amid several countries adopting different sets of rules to allow foreigners to enter their territory in the wake of the COVID-19 pandemic.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
Modi tweeted that the meeting discussed important issues related to the progress of vaccine development, regulatory approvals and procurement.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively.
Stressing that the Covid virus may continue to transmit for a "very long time", senior WHO official Poonam Khetrapal Singh says the level of immunity in a community, through vaccination and previous infection, will determine whether it will become endemic in the long run.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, the Union health ministry said.
Interacting with state chief ministers, Modi underscored the enormity of what he described as the world's biggest vaccination exercise, which begins from January 16, saying over 30 crore citizens will get the jabs in the next few months in India against only 2.5 crore people vaccinated so far in over 50 countries in around a month.
Three entities are at the centre of this controversy: The Brazilian government, Bharat Biotech and a Singapore-based company called Madison Biotech.
The vaccine arrives at a critical moment for the US. Hospitalisations due to COVID-19 hit record highs for the seventh day in a row on Saturday.
According to The New York Times, this move means that many highly vulnerable people will begin receiving the vaccine within days. It further called the authorisation by the FDA as a 'historic turning point' as the US death toll from the Wuhan-originated virus nears 300,000.
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
The Covishield maker's forte throughout the past half a century has been a combination of affordable vaccines and high volumes. Its tetanus, diphtheria and measles vaccines are known throughout the world, reports Sohini Das.
Apart from the 1.1 crore doses of Covishield being procured from the Serum Institute of India, 55 lakh doses of indigenously developed Covaxin were being obtained from Bharat Biotech, Union Health Secretary Rajesh Bhushan said at a press conference.
'This government did not have any plan for safety stocks of essential medicines.'
The Reproduction number or Rt refers to how many people an infected person infects on average. In other words, it can tell how efficiently a virus is spreading.
Of those who were willing to pay, two-third said they can pay up to Rs 500 for two doses of the vaccine, whenever it is available.
"Confidence in the vaccine is what brings us here this morning," the US vice-president said in remarks following his vaccination. "I didn't feel a thing. Well done."
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
Replying to a short duration discussion on COVID-19 management in Rajya Sabha, the minister said technology transfer to several companies has started and they will begin production in the coming days to reduce vaccine shortage in the country.
Providing data, it said UK's Public Health England has reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021).
Behind each Covid vaccine are hundreds of parents, who had the courage and conviction to come forth with their children for the trial of a vaccine which was, until then, untried in that age group, reports Sindhu Bhattacharya.
'Until the case load starts dropping, we will have to keep up the current level of prevention activities.'
During the webinar, 'COVID-19: Vaccination and Potential Return to Normalcy - If and When', Dr Hotez, an internationally-recognised physician-scientist in neglected tropical diseases and vaccine development, said that the COVID-19 vaccine rollout is "India's gift' to the world in combating the virus.
The Indian Council of Medical Research will start national-level sero surveys to assess the spread of Covid-19 and all states/Union territories should also be encouraged to conduct them so that information from all geographies can be collected, the Union health ministry said on Friday.
The COVID-19 vaccination drive was successfully conducted on the first day, Additional Secretary in the Union health ministry Manohar Agnani said during a press briefing. Giving an update on COVID-19 vaccination, the health ministry said 3,352 vaccination sessions were held and 1,91,181 beneficiaries vaccinated.
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