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coronavirus India Latest News

DCGI allows clinical trial of Covaxin on 2 to 18-yr-old

New Delhi: The Drugs Controller General of India (DCGI) has accorded permission to conduct the Phase II-III clinical trial of Covaxin (Covid vaccine) in the age group of two to 18-years-old to its manufacturer Bharat Biotech Ltd, Union Health Ministry said.

“The trial will be conducted on 525 healthy volunteers,” said the Ministry.

In the trial, the Ministry said, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.

After careful examination, the DCGI accepted the recommendation of the Subject Expert Committee (SEC). The national drug regulator of the country gave the approval to conduct the clinical trial in the youngest age group till now paving way for them to be saved from the deadly pandemic outbreak.

Hyderabad-based Bharat Biotech International Ltd (BBIL) had proposed to carry out a Phase II-III clinical trial of Covaxin in the age group of two to 18 years.

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (Covid-19) on May 11 this year.

The committee after detailed deliberation recommended grant of permission to conduct proposed Phase II-III clinical trials to certain conditions.

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coronavirus India Latest News

Second wave of Covid and India’s political landscape

By Ramanand and Dhanisha 

A little over a year since India first began its battle with the covid-19 pandemic, and it is apparent to any observer that once again, India is standing more towards the losing half. In March 2020, confronted with the emergence of the virus and simultaneous lack of resources to tackle the same, especially in terms of medical infrastructure, the Indian government opted for a nationwide lockdown. 

Therefore, despite the many negative economic consequences, this hard response did succeed in keeping control of the spread while India acquired the necessary resources and began working on vaccines. Now, the country is in the midst of a grave second wave with cases rising to numbers higher than last year, and the response seems to be lacking. One reason behind this, no doubt, is the heavy influence of politics that seeps into all aspects of life. For instance, the government’s reluctance to impose reasonable restrictions during the flurry of public gatherings took place from August 2020 onwards. 

 

We can take lessons from the state of Kerala. Initial response to COVID-19 by Kerala was claimed as one of the success stories quoted as the state managed to mitigate the crisis and bring down cases rapidly as early as May. However, later found, it was an early celebration because the instances kept rising after that. It has begun with a public gathering celebration of the Onam festival, followed by Christmas later on in December. It is characteristic of politics not directly to intervene with such functions despite the negative long-term impact, and therefore in Kerala, these were celebrated without much restriction. 

Maharashtra is another example where the cases rose and contributed more than 30% in the overall cases. Maharashtra is one of the epicentres of the Covid-19 issues, continuously contributing for the last four months. The political misgovernance and mismanagement have badly hampered the battle against Covid-19 in the state. 

The election is another occasion that has contributed to the current rise of Covid-19 cases. PM Modi is keeping advocating for ‘One Nation, One Election to save time and resources, which we keep spending on the elections. Due to political compulsion, his demand is still pending as many political parties do not agree to this demand. For the implementation of ‘One Nation One Election, some state assemblies must resolve early or come under the president rule.

 

The present rise could be controlled if we would have a system of simultaneous election. The election is one occasion where people rarely follow social distancing norms; it has been validated repeatedly by political parties’ conduct.

The imposition of weekend lockdowns and night curfews is being adopted by many states – Delhi, Maharashtra, Punjab, MP, Uttar Pradesh – in response to the recent surge of cases.

The lockdown again will attack the poor’s livelihood who are employed in restaurants, hotels, taxi’s or employed/self-employed in other dependents fields.

The response to the second wave brings about two important considerations. First, the role played by politics, in terms of the surface level politics of governance in the face of rising cases and times of the entire political process contributing to this rise during rallies, campaigns and misgovernance of some states. 

Second, noting that India’s vaccine diplomacy’s criticism in terms of doses exported also comes from the political blame game. In troubling times, one cannot afford to be selfish, and in extending vaccines to other countries, India is far from it, and the efforts should thus be recognized.

(The Op-Ed appeared in The Times of India)

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coronavirus India Latest News

India’s vaccine strategy is based on science

By Vijay Chauthaiwale

India has been undertaking the world’s largest vaccination drive. In less than three months, we have managed to provide more than 100 million doses across the country, which is more than the population of Germany. The country has already achieved one of the highest daily vaccinations per day across the globe with 4.3 million vaccinations, which is close to the population of New Zealand. 

India has also achieved the fastest rate of reaching the 100 million vaccination milestone, ahead of the United States (US) and China. Our daily vaccination rates are also among the highest in the world. This doesn’t mean that there is no scope for improvement. Of course, we need to expand capacity and continue innovating, which has been our approach throughout the pandemic.

In the beginning, there are two insinuations — first, that there is a vaccine crunch, and, second, that everyone immediately needs a vaccine. We must understand that vaccines are a scarce commodity in the world. They are not like candies which can be manufactured, supplied, and consumed any time and anywhere. 

That is why India, as well as other countries, decided to prioritise groups which are vulnerable. The primary purpose of vaccination is mortality reduction and decreasing the burden on the health care system. This was laid down by the government in 2020 itself.

India has set a target of vaccinating around 300 million vulnerable citizens by August, and we are very much on course to achieve that. There is no supply crunch when it comes to achieving this target.

Here, it is also important to understand that vaccines are a preventive tool which works after a lag period of six to 10 weeks. It is not a treatment to be administered to reduce the case-load in the middle of a wave. To focus only on vaccines and not pay attention to ramping up testing, tracing and proper treatment will be counterproductive.

At this rate, shall we make the vaccination programme more targeted and focus on high-rises and slums within cities? Shall we focus more on malls and markets given the high density of people found here? Is there a successful display of this strategy anywhere in the world? However provocative the argument is, when a government decides on a strategy, it needs to be both equitable and feasible. 

Adding additional layers of complexity is neither feasible nor desirable.

(The Op-Ed appeared in The Hindustan Times)

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coronavirus India Latest News

India to vaccinate all over 45 from April 1

New Delhi: People who are 45 and older can be vaccinated from April 1, the government said Tuesday, ramping up the nationwide inoculation drive at a time Covid cases have surged in many states. “I appeal to every citizen who is 45 or above to register for vaccination,” Union Minister Prakash Javadekar said, announcing the cabinet decision to expand the drive that started in January.

So far, only citizens above 60 and those over 45 with other illnesses are allowed to get vaccination. A meeting chaired by Prime Minister Narendra Modi decided to vastly widen its reach to cover much more of the population. Those 45 and above can start registering for vaccination from April 1.

“This decision has been taken by cabinet on the basis of the advice of the coronavirus Task Force and experts,” said Javadekar.

He asserted that there was no shortage of vaccines and more were on the way.

According to the minister, 4.85 crore people have received at least one dose of the Covid vaccine and 80 lakh have received the second dose.

On the center’s letter to states to increase the gap between two doses of Serum Institute of India’s Covishield developed by Oxford-Astrazeneca – Javadekar said doctors would prescribe the right time for the second dose.

“The second dose has to be between four to eight weeks. Doctors will decide when it is best to take the second shot,” the Union Minister said.

Vaccinations rolled out with two vaccines – Covishield and Bharat Biotech’s Covaxin — on January 16 with healthcare workers. Frontline workers were declared eligible for the shots February 2 onwards.

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Latest News USA

India’s Covid-19 vaccine rollout has ‘rescued the world’ from pandemic says top US scientist

Houston: The rollout of the Covid-19 vaccines by India in collaboration with leading global institutions has “rescued the world” from the deadly coronavirus and the contributions by the country must not be underestimated, a top American scientist has said.
India is called the pharmacy of the world during the Covid-19 pandemic with its vast experience and deep knowledge in medicine. The country is one of the world’s biggest drug-makers and an increasing number of countries have already approached it for procuring coronavirus vaccines.

Dr Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine (BCM) in Houston during a recent webinar said that the two mRNA vaccines may not impact the world’s low and middle income countries but India’s vaccines, made in collaboration with universities across the world such as BCM and the Oxford University, have “rescued the world” and its contributions must not be underestimated.
During the webinar, “Covid-19: Vaccination and Potential Return to Normalcy – If and When”, Dr Hotez, an internationally-recognized 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.
India’s drugs regulator gave emergency use authorization to Covishield, produced by Pune-based Serum Institute of India after securing license from British pharma company AstraZeneca, and Covaxin, indigenously developed jointly by Hyderabad-based Bharat Biotech and Indian Council of Medical Research scientists.
The webinar was organized by the Indo American Chamber of Commerce of Greater Houston (IACCGH).
“This is something very special and I see it myself because I’m on weekly teleconferences with our colleagues in India, you make a recommendation, and within days it’s done and not only done, but it’s done well and with incredible rigor and thought and creativity,” Dr Hotez said, stressing that he felt compelled to make this statement because “India’s huge efforts in combating global pandemic is a story that’s not really getting out in the world.”
Dr Hotez, considered as the authority on vaccinations, is working on an affordable coronavirus vaccine in collaboration with Indian pharmaceutical companies.
Consul general of India in Houston, Aseem Mahajan, along with a distinguished panel of doctors participated in this webinar, that tracked the possibilities of a return to some semblance of normality due to the accelerated roll out of vaccines across the country.
Appreciating Dr Hotez for commending India’s efforts in getting vaccines to the world, consul general Mahajan, said, “In keeping with our tradition of sharing with the world, India has exported vaccines to many countries across the world.”
India has provided 56 lakh doses of coronavirus vaccines under grants assistance to a number of countries. The vaccines were sent to Sri Lanka, Bhutan, Maldives, Bangladesh, Nepal, Myanmar and Seychelles.
There has also been a boost in the collaborative medical partnerships emerging between the US and India during this pandemic. In addition, India is one of the fourth largest destinations in Asia for medical devices manufacturing and many US companies have expressed interest in collaborating on this front, Mahajan said.

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India Latest News

PM Modi takes first dose of Covid-19 vaccine at AIIMS

Prime Minister Narendra Modi on March 1 tweeted to say that he took the first dose of the coronavirus vaccine at Delhi’s premier All India Institutes of Medical Sciences.

“Took my first dose of the COVID-19 vaccine at AIIMS. Remarkable how our doctors and scientists have worked in quick time to strengthen the global fight against COVID-19,” he tweeted.

“I appeal to all those who are eligible to take the vaccine. Together, let us make India COVID-19 free!” Modi

Sister P Niveda from Puducherry administered Bharat Biotech’s COVAXIN to PM Modi.

This comes as India begins the third and the largest phase of vaccination drive against coronavirus, which will reach out to around 27 crores of the population aged above 60 or above 45 with co-morbid conditions.

Registrations are set to open at 9 am at www.cowin.gov.in and the Aarogya Setu app and there will be walk-in vaccinations in some places as well.

India began its vaccination drive on January 16 intending to inoculate 3 crore frontline workers but has struggled with hesitancy, giving out some 1.43 crore shots so far.

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India Latest News

Adverse events following immunization low: India

New Delhi: The Union Health Ministry said that a total of 4,54,049 people have been inoculated since the commencement of the vaccination drive, and only 0.18 per cent of beneficiaries developed adverse events following immunization, while 0.002 per cent were hospitalized.

“The adverse events following immunization are fairly low. In fact, these are the lowest in the world in the first three days. In India, we have an extremely robust system of adverse events following immunization reporting and management,” said Union Health Secretary Rajesh Bhushan in a bid to allay fears and vaccine hesitancy.

According to the government’s data, 580 adverse events have been reported so far, out of which seven required hospitalization.

“Only 0.18 per cent of beneficiaries developed adverse events following immunization, while 0.002 percent were hospitalized,” the Health Secretary said.

“There are mild AEFI, severe AEFI, and serious AEFI. In India, anxiety or hysteria is also recorded. We must dispel this notion that AEFI means that people have lost consciousness and were hospitalized. If post-vaccination, I have a crying bout, even that is captured. It may add to the number but it subsides.”

He also said that deaths of two men in Uttar Pradesh and Karnataka following immunization were found to be not related to the vaccination.

A 52-year-old man from Uttar Pradesh’s Moradabad district died due to cardiopulmonary disease one day after being vaccinated, while a 43-year-old resident of Karnataka’s Bellary died due to cardiopulmonary failure two days later.

The nation-wide vaccination drive had kick-started on January 16.

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coronavirus India Latest News

The uncertainty over vaccine authorization

By Karan Thapar

Just when we needed clarity, we ended up with controversy. When we want simple, straightforward answers, we are receiving confused and conflicted responses. Consequently, the authorization of two vaccines to tackle Covid-19 has been met with as much consternation as celebration. For many, the doubts and questions that have arisen have created fresh concern.

To get a good grasp of the situation, you can’t do better than listen to Prof Gagandeep Kang. She’s considered India’s top vaccine scientist. She’s also a Fellow of the United Kingdom’s prestigious Royal Society, and a recipient of our own acclaimed Infosys Prize. Her views clash with two of the government’s top doctors, Balram Bhargava and Vinod Paul, but her clarity is exemplary. Also, she has no axe to grind. Bhargava is part of the Covaxin project. That’s why it’s worth hearing Kang before you make up your mind.

Kang questions the emergency-use clearance for Covaxin.

She says the precedent set by the Ebola and Nipah vaccines, which were cleared without completing Phase 3 trials and obtaining efficacy data, does not apply to Covid-19. This is both because of differences in their mortality rates as well as the fact we have other licenced products to tackle Covid-19. “I would ask why would you want to give a vaccine without emergency-use authorization in these circumstances?” she asks.

Kang also casts doubt on the Bhargava/Paul claim that Covaxin has been cleared because it could be better at tackling new strains of the virus. “I wish we had data to establish this,” she says. “At the moment we don’t.” The Bhargava/Paul claim is simply a “hypothesis”.

Kang says she’s “really confused” Covaxin has been cleared for use “in clinical trial mode”. She’s “not sure what that means”. It suggests people given this vaccine could end up being part of its continuing clinical trials. Of course, that will only happen with their consent but it’s not what they intended. They want a guaranteed vaccine. Not to be part of the process by which that guarantee is established.

Finally, when asked if she would be prepared to take Covaxin, Kang said while she was willing to participate in the clinical trial of any vaccine — as her personal contribution to science — she would not take Covaxin until its Phase 3 trials are complete and the required efficacy data made public.

Kang has stolen a march by speaking out comprehensively and forthrightly. Most others have spoken in sound bites. Now that she’s explained her position, we can only benefit from it. Of course, it’s up to us to agree or disagree. Not being experts, we’re unlikely to do so with conviction. But her views can only help.

(The opinion piece appeared in The Hindustan Times)

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e-paper-stories Latest News

India beginning Covid vaccine drive from Jan 16

India beginning Covid vaccine drive from Jan 16

New Delhi: India is all set to kick off the vaccination drive against Covid-19 on January 16, the central government has said.

The rollout of Covid vaccine will provide priority to the healthcare workers and the frontline workers who are estimated to be around 3 crore, followed by those above 50 years of age and the under-50 population groups with co-morbidities numbering around 27 crore, reports  Indian Express.

The government has scheduled to start the drive just after the forthcoming festivals such as Lohri, Makar Sankranti, Pongal among others.

Giving the information, Prime Minister Narendra Modi tweeted: “On 16th January, India takes a landmark step forward in fighting COVID-19. Starting that day, India’s nation-wide vaccination drive begins. Priority will be given to our brave doctors, healthcare workers, frontline workers including Safai Karamcharis.”

On Saturday, PM Modi chaired a high-level meeting to review status of COVID-19 in the country along with preparedness of the states and UTs for Covid vaccination. The meeting was attended by Cabinet Secretary, Principal Secretary to PM, Health Secretary, and other senior officials.

During his 16th Pravasi Bharatiya Diwas address on Saturday, PM Modi said India is ready with two vaccines for the protection of humanity and the world is not only waiting for them but also watching how the country runs the globe’s biggest vaccination program.

India’s drugs regulator recently approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and the indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country. Two dry runs of the vaccines have also been conducted across the country to understand the best way to administer them and plug loopholes in logistics and training.

Modi lauded India’s fight against COVID-19 and said we are among the countries with the lowest fatality rate and the highest recovery rate. He also said the way the country stood together during the pandemic was unparalleled. “Being the pharmacy of the world, India has supplied important medicines to all those in need in the world and continues to do so”, he said.

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