Connect with us

National

Bharat Biotech Submitting Data “Regularly, Very Quickly”: WHO Official On Covaxin – dot newz

Published

on


The official said WHO is in touch with Bharat Biotech and has “daily conversations”

United Nations/Geneva:

India’s Bharat Biotech has been submitting data on the EUL of Covaxin “regularly and very quickly” to a technical committee which hopes to have a final recommendation to the WHO next week, a top official of the global health agency said on Thursday, stressing that the UN body “trusts” the Indian industry that manufactures high quality vaccines.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for the vaccine’s Emergency Use Listing (EUL).

A technical advisory group of the UN health agency which met on Tuesday has sought “additional clarifications” from Bharat Biotech for Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine.

“Let me say that Bharat has been submitting data regularly and very quickly, but they submitted the last batch of data on the 18th of October,” Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products at WHO, said at a press briefing in Geneva.

She was responding to a question on the delay in granting the Emergency Use Listing to Covaxin while Chinese vaccines Sinopharm and Sinovac were given approval even “with lack of data.”

Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, they asked Bharat Biotech for additional clarifications. The technical advisory group will reconvene on November 2 for the final risk-benefit assessment of Covaxin EUL.

She said WHO is in touch with Bharat Biotech and has “daily conversations” and calls and meetings “clarifying what additional data needs” to be submitted to the technical expert group.

“Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days,” she said, a reference to the Serum Institute of India which manufactures the AstraZeneca Covishield vaccine.

“So this is not about moving quicker with one or another vaccine…We really trust the Indian industry. India produces different majority of vaccines in the world, high quality vaccines. We are right now at the last stage of the assessment by this external advisory group and we hope to have a final recommendation to the WHO next week. I hope that’s well understood.”

She said that it is important to highlight that the process that WHO uses for issuing the Emergency Use Listing is a very transparent process and there are “no secrets” involved except for any confidential information.

“Everything else, the procedures that WHO uses, are independent of which country is manufacturing the vaccine,” she said, adding that the process is based on the best international standards available.

Simao also noted that sometimes WHO needs to inspect the manufacturer, if it hasn’t done an inspection in the recent term.

“It wasn’t the case of Bharat. We did not need to inspect Bharat,” she said, adding that once the manufacturer has completed submitting all the data to WHO, it is put through for assessment by an external Technical Advisory Group, which comprises experts from six different nationalities and they look at all the data that has been collected by WHO, provided by the manufacturer in recommend the Emergency Use Listing.

She noted that in the case of the two Chinese vaccines also, the group had asked for additional clarifications and the entire process was followed to assess the Chinese vaccines. One of the Chinese vaccines was issued Emergency Use Listing one month after the first technical advisory group meeting, while the second vaccine was given EUL after six weeks, she said.

Simao noted that at the moment, including Bharat Biotech’s Covaxin, WHO is assessing eight vaccine candidates.

She said Bharat Biotech started the rolling submission on July 6. “We are treating this as a very urgent matter and we have teams working seven by seven on the topic.”

Responding to the Covaxin question, Dr Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus, said that in the “stressful situation we are all working under in this pandemic, it is so important that we’re accurate in the information that we use and that we share. And we just want to highlight, be on the record, that there were a number of inaccuracies in the way the issue was presented.”

He added that the actual information about the EUL dates, process is all available transparently on WHO website.

“We’re committed at the organisation from the very top under the Director General to move these processes as rapidly as possible. But let”s be very clear, the timeline for EULing a vaccine depends 99% on manufacturers, the speed, the completeness with which they can get data to the independent groups that assesses for WHO. We just want to be very, very clear on that point.”

Aylward added that WHO’s job is to save as many lives as possible and as fast as possible. This includes ensuring no product lies unused.

While the organisation does everything, he said, “we need manufacturers, the regulator agencies, others we work with to make sure they have the information they need to make those determinations. We need to make sure the products are safe and effective and produced to the right quality. And that takes a little bit of time, but it’s in the interest of global safety.”

WHO Chief Scientist Soumya Swaminathan said that one of the reasons for the high amount of stress that people who’ve received vaccines which are not yet approved, either by WHO or by any of the other main stringent regulatory agencies, is “because of restrictions in travel that have been imposed.”

She reiterated that the emergency committee that reviews the International Health Regulations met again last week and underlined their previous recommendations that countries should not use vaccination status or selective vaccination status as the sole criteria for entry for travel.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)



Source link

National

China Poses Significant Challenge To India’s Strategic Goals: Air Chief – dot newz

Published

on

By


Air Chief Marshal VR Chaudhari said the Indian Air Force needs to be rapidly modernized. (File)

New Delhi:

Air Chief Marshal Vivek Ram Chaudhari said that China poses a significant long term challenge to India’s strategic goals. He said it should be made clear to the world that today’s India has the capability and will to respond at a level that the nation deems appropriate.

“China poses a significant and long-term challenge to India’s strategic goals. Both People’s Liberation Army Air Force (PLAAF) and Pakistan Air Force (PAF) have enhanced their military capabilities in equipment and infrastructure. The Indian Air Force (IAF) needs to be rapidly modernized, expand its fleet and improve indigenous manufacturing capabilities,” the IAF chief said at a seminar conducted by the Centre for Air Power Studies.

The IAF needs to be rapidly modernized, expand its fleet and improve indigenous manufacturing capabilities, he urged.

The IAF chief said that China’s hegemonic and entrapping policies can provide opportunities for India to leverage in trade and military domains.

He also asserted that India has demonstrated its capabilities during a standoff on the northern border while simultaneously handling the national COVID-19 response.

“In the future, we could be attacked from all fronts, starting from economic strangulation to diplomatic isolation and military stand-offs to information blackouts, in the form of attack by a distributed denial of services. We will need to prepare for the full spectrum,” the Air Force chief cautioned.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)



Source link

Continue Reading

National

Gen Rawat Was On “Very Safe” Mi-17V-5, Crash Confounds Experts – dot newz

Published

on

By


India owns a fairly large fleet of Mi-17V-5 helicopters that are often used to ferry VIPs.

New Delhi:

The Mi-17V-5 helicopters are extremely reliable and are the workhorses of the Air Force, several former army officers told NDTV after one of these choppers crashed in Tamil Nadu, with Chief of Defence Staff Bipin Rawat and several members of his family on board. The crash perplexed the experts, who said the flight from Sulur to Wellington did not involve complications.

Four people are dead and another four who survived, have been taken to a hospital. It is believed that there were 14 people on board, including the chopper’s crew and passengers.

The Indian Air Force has already ordered an inquiry into the crash.

The Mi-17V-5 is the latest twin-engine iteration of the Russian-made Mi-17 transport helicopter and is used regularly for high-altitude operations. One of the most advanced military transports that can be used in any topography and weather, it is one of the most powerful choppers used by Indian defence forces.

India owns a fairly large fleet of these helicopters that were purchased and inducted between 2013 and 2018.

Most experts NDTV spoke to described it as a “very reliable, safe, stable, and large” helicopter that is also used to ferry VIPs, including the President and the Prime Minister.

According to information available on the website of Rosoboronexport — the Russian arms supplier — the chopper is designed to “carry personnel, cargo and equipment inside the cargo cabin or on an external sling, drop tactical air assault forces and reconnaissance and sabotage groups, destroy ground targets and carry the wounded”.

“Its armament system includes unguided rockets (up to 80 S-8 80mm unguided aerial rockets), cannons (suspended pods with 23mm cannons and 250 rounds each) and small arms,” the website says.



Source link

Continue Reading

National

‘Smartphones, Scootys, Security’: Congress’ “Women’s Manifesto” Before UP Polls – dot newz

Published

on

By


UP will vote for a new government in 2022, with the Congress challenging the BJP

Lucknow:

Girls studying in Classes 10 to 12 in Uttar Pradesh schools will get smartphones and female graduate students will get scooters, Congress leader Priyanka Gandhi Vadra said Wednesday as part of a six-point “woman’s manifesto” ahead of an Assembly election in the state in a few months.

Ms Gandhi Vadra – who is leading her party’s campaign in the poll-bound state – read out a number of measures and schemes the Congress plans to implement should it win next year’s election, and demanded that all parties understand “the fact women have to bear with exploitation”.

Promises made by Ms Gandhi Vadra today include the offer of three free LPG cylinders for women – a significant offer given the skyrocketing prices of gas cylinders in the country, something for which the BJP (in power in UP and at the centre) has been severely criticised.

“I hope this women’s manifesto will put pressure on other political parties to also speak about similar issues. We want to release a women-specific manifesto so women have freedom of choice… I have seen that women ka bahut shoshan hota hai but they are fighting for their rights,” she said.

Ms Gandhi Vadra also highlighted the Congress’ promise to reserve 40 per cent of its election tickets for women; “this is not only on paper,” she said, giving late Indira Gandhi – India’s first woman prime minister – as an example of the Congress’ contribution to women in politics.

“Our attempt is to bring real women’s empowerment… at the grassroots level. Women’s empowerment is usually spoken about before elections and then mostly restricted to being on paper. We want to actually empower women on ground,” the Congress leader said.

“Parliament and legislative assemblies have an average of 14 per cent participation by women representatives. That needs to increase… we want that 40 per cent of all seats should be represented by women. This will increase their participation in policy-making,” she stressed.

Apart from smartphones, scooters and free gas cylinders, Ms Gandhi Vadra said women senior citizens and widows would get a monthly pension of Rs 1,000, and every new-born girl will get a fixed deposit in her name. All households with women will get a free internet connection.

Ms Gandhi Vadra also flagged the issue of women’s security – a serious subject given the worrying number of violent crimes against women reported from Uttar Pradesh.

“We want 25 per cent of the police to consist of women. All chowkis to have at least one woman officer and constable,” she said, reminding reporters that many crimes were unreported as the police is reluctant to file a case. “More women in the force will help the cause of women,” she said.

The Congress also promised Rs 10 lakh medical cover for women “for any kind of illness or disease”.

UP votes for a new government in a few months time.

The Assembly election here – for 403 seats – is widely seen as an indicator of how the ruling BJP might fare in the 2024 general election, when Prime Minister Narendra Modi and his party will seek a third consecutive term in power.



Source link

Continue Reading

Trending

Copyright © 2017 Dot Newz | Developed by MCVP Group 8