New Delhi: The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of a COVID-19 vaccine candidate, developed by the University of Oxford, in the country.
Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.
As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, "Covishield", on healthy adults in India, the officials said.
"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said.
"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
The officials said that the SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.
The panel has also recommended that the clinical trial sites which have been proposed for the study be distributed across India.
According to the revised proposal, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ''Covishield'' on healthy Indian adults," the official said.
The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.
Oxford Covid Vaccine: Serum Institute Gets Nod For Phase 2, 3 Human Trial
Philippine Doctors, Nurses Saying Their Losing Battle Against Covid-19
Philippine Doctors, Nurses Saying Their Losing Battle Against Covid-19
Philippines tightens Manila lockdown amid 'losing' virus battle
Philippines tightens Manila lockdown amid 'losing' virus battle -
Nikkei Asian Review
Bloomberg - Are you a robot?
https://www.bloomberg.com/news/articles/2020-07-31/japan-acted-like-the-virus-had-gone-now-it-s-spread-everywhere
Meanwhile, back in Thailand, which has done admirably well in its response to protecting its people from the pandemic, we have this:
Money, money, money, It's all about the Money!
Thailand must welcome back Chinese tourists now says leading tourism chief - Thailand News - Thailand Visa Forum by Thai Visa | The Nation
Thailand must welcome back Chinese tourists now says leading tourism chief
A leading tourism chief has said that it is time Thailand opens up again to foreign tourists and Chinese tourists in particular.
The pandemic has left the Chinese largely friendless around the world and it's time that Thailand's "special relationship" with the Chinese was resumed.
But it is also time that the Thais get more of their hands on the tourism dollar and not let cash seep out of the country.
Surawat Akaraworamat, the secretary general of the Tourism Council of Thailand and vice president of ATTA was speaking at a seminar about Thai tourism and the economy.
"China is in trouble," he said. "No one wants Chinese tourists but we (in Thailand) should welcome them back. We have always had a special relationship with the Chinese".
He said that if Thailand opened up its airspace the Chinese would come in good numbers. There was no need for a high level of marketing. They know very well about Thailand and would flood back in.
Surawat said it was time for those in tourism areas to be asked their opinions about reopening the country.
And time for the state and business operators to work more closely together.
Foreign tourists in general - who spend an average of 50,000 baht each - must be encouraged to return. They spend 2 trillion baht a year.
But Surawat said it was time for the Thais to review how to ensure that more tourism revenue stays in the country and does not flow abroad.
He was referring to companies - many of them Chinese owned or owned in Thailand through proxies - who are involved in organising group tours.
Much of the money ends up abroad and not in the hands of Thais.
This needs to be addressed, he said at the seminar, particularly in the booking of accommodation.
Actually Chinese would be safer than Americans.
They take that shit seriously here.
Arizona woman who destroyed Target mask display has some regrets, she says
"she lost all of her public relations firm’s clients after her infamous anti-mask tirade inside the Scottsdale, Ariz. store."
Woman who destroyed Target mask display has some regrets - New York Daily News
Thailand must welcome back Chinese tourists now says leading tourism chief - Thailand News - Thailand Visa Forum by Thai Visa | The Nation
TIT's or world wide?
Sensible people or robots?
A tray full of GOLD is not worth a moment in time.
It's difficult. People are screaming for a vaccine now. Common sense says wait until a thorough testing regimen is complete.
I think the answer will lie somewhere in between.
They might, for example, tell people to lay off getting pregnant while taking the vaccine.
Dubai International Airport (DXB) started using police dogs for on-airport rapid COVID-19 testing, which reportedly can produce results in minutes with 92 percent accuracy.
Corona Virus Vaccine
redacted
BBC News: Coronavirus vaccine: When will we have one?
By James Gallagher Health and science correspondent 21 July 2020
Coronavirus still poses a significant threat, but there are no vaccines proven to protect the body against the disease it causes - Covid-19.
Research is happening at breakneck speed. About 140 are in early development, and around two dozen are now being tested on people in clinical trials.
When will we have a coronavirus vaccine?
A vaccine would normally take years, if not decades, to develop. Researchers hope to achieve the same amount of work in only a few months.
Most experts think a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged. That would be a huge scientific feat and there are no guarantees it will work.
How many people need to be vaccinated?
It is hard to know without knowing how effective the vaccine is going to be.
It is thought that 60-70% of people needed to be immune to the virus in order to stop it spreading easily (known as herd immunity).
But that would be billions of people around the world even if the vaccine worked perfectly.
So, once a vaccine is proved and available it must be mass produced and then Billions of people inoculated. And, as per the article, that is with a 100% effective vaccine. It is apparent the genie is out of the bottle. Pandora’s Box has been opened and the horse has left the barn. There is no going back.
Can any country effectively seal all borders to protect its residents from Covid and still sustain itself? As sealing borders results in a serious disruption of trade and just how many countries are in a position to self sustain?
Covid is here and here to stay – protect yourself on an individual basis. Your administrators have proven they cannot.
And yes, I know there are a few countries (including the one I reside in) that have done exceeding well protecting their residents on a comparative basis. Yet, I fully expect the lure of trade, commerce and money will overcome the fear of Covid and repairing the Economic Damage will override the fear and consequences of the Medical Damage.
Last edited by bowie; 04-08-2020 at 08:01 AM.
Understandable, there are lots of dormant Chinese-owned hotels, restaurants and businesses that need to get moving again, and no doubt a few baht will be passed to whichever politicians assist in this virtuous endeavour.
As you say it's all about money and more money.
Otoh, there should be no objection to Chinese tourists being allowed to enter Thailand, or any other visitors ftm, if they go into strict quarantine and conditional upon ongoing observation before being released to support the grand reopening.
There is no win-win considering it has already taken 700k lives and threatened the global economy; unless the virus is somehow beaten or dies off naturally, best 'win' situation is to resume a compromised form of normality at some time in the future.
We either wait for vaccines to go the full route to certfication, which most 'experts' say could take years, or fast track and cut corners with associated risks. One or the other, with no viable alternative.
Meanwhile, no pharma would accept early release of their vaccine without guarantees of immunity against long term effects; that's crazy to suicidal. It makes more sense for them to continue R&D, mostly covered by gov subsidies, and sit on them which piles the pressure onto desperate politicians.
The job of the pharmas is to develop the vaccines, but the onus is on the authorities to certify them.
I think it will be fairly quick, and pretty safe. One of the biggest problems in vaccine development is simply having enough people with a high probability of becoming infected to see if the vaccine has a protective effect. In addition there will be a relatively small time window to see if there is a protective effect.
This case is almost unprecedented. Last decent example was Zika -by the time there were candidate vaccines ready -the epidemic was gone - not enough transmission to set up clinical trials. That is not the case here.
I've got to say that Brits, for the most part, seem to be stepping up and adhering to the rules - even the chavs, in between setting fire to park benches and nitrous oxide hits, are playing the game. Quite impressed.
A bit of clarification concerning those allowed potential entry into Thailand - Not an Official Announcement - from the Pattaya Mail Newsletter
Foreign tourists and retirees excluded from latest approval list to come to Thailand - Pattaya Mail
Foreign tourists and retirees excluded from latest approval list to come to Thailand
By Barry Kenyon August 4, 2020
New tourists and retirees stuck abroad aren’t rejoicing right now
This week the powerful Centre for Covid-19 Situation Administration (CCSU) has updated the groups of foreigners able to apply to board a plane to Thailand. Mostly they are categories who have business or work-related documentation or are thought to be affluent, such as those holding a Thailand Elite privilege card.
There are a few eligible groups which can be broadly described as humanitarian gestures, including foreigners with Thai spouses and/or family financial responsibilities and those classed as “residents”, a much misunderstood term which refers exclusively to those who have no end date in their passport when they must leave the country or renew.
A slightly odd grouping refers to medical tourists, usually thought to be magnificent contributors to the Thai treasury. However, the websites of Thai embassies abroad (including the UK) are stating that, to be eligible, you must have a letter from a hospital in your home country stating that you have a life-threatening disease that cannot be treated there. Very odd rule when you think about it.
All these groups can board a plane only when their Thai embassy issues a certificate of entry which requires voluminous paperwork, expensive insurance and 14 days quarantine on arrival at your own expense. The Thai foreign affairs ministry is also stressing that entry approvals will be handled on a case by case basis. Almost all the permitted groups will require a non-immigrant visa.
Meanwhile, Thai border posts remain closed for most human traffic, although laborers from neighboring countries who have registered online are trickling back to jobs in the construction, fishing and retail industries. New arrivals are subject to virus testing and quarantine facilities. Legal workers from Myanmar, Cambodia and Laos are governed by the multi-governmental Memorandum of Understanding (MOU), although non-registered or illegal workers are by no means unknown.
In other words, foreigners who want to vacation in Thailand are excluded from the eligible groupings and likely to remain so as the government aims for continued zero community infections. All talk of travel bubbles, for example, appears to have been dropped as second-wave infections cause panic in countries such as Vietnam, China and Australia which were being considered as partner just weeks ago. Thai embassies abroad specifically state that they will not issue visas or certificates of entry for tourism or retirement.
There has been substantial publicity about the plight of mainly European expats with one-year retirement visas or extensions of stay who are marooned abroad but want to return to Thailand. We now know for sure that retirees are considered as tourists in this context, unless perhaps they can separately prove a live marriage to a Thai national. Retirees sometimes believe they are Thai residents because they have bought property or believe the Land of Smiles is their home. On the other hand, retirees are seen by the authorities as one-year-at-a-time tourists. Although they are formally required to show an income or have a Thai bank balance of at least 800,000 baht to qualify, the regulation is sometimes circumvented by third party intervention by generous friends or agents.
The reality is that 90 percent of the foreigners who visited Thailand in 2019 would be banned by the CCSU regulations now in force. Whilst the scenario can change at short notice – a vaccine appears or the virus goes into remission worldwide or government policy changes – it’s demonstrably untrue that Thailand is slowly getting back to normal. And you can’t predict the future because, alas, it hasn’t happened yet.
Something a lot of farang should note.retirees are seen by the authorities as one-year-at-a-time tourists.
Slap, honestly, that is so far out of whack. Both Thailand and UK got their first imported cases in Jan 2020. Since then Thailand has had 3,000 (three thousand) or so cases and 58 deaths. UK has had 300,000 (three HUNDRED thousand) or so cases and more than 46,000 deaths.
You really should not be impressed.
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