WASHINGTON, (Reuters): Pfizer Inc and BioNTech have asked U.S. regulators to approve emergency use of their COVID-19 vaccine for children aged five to 11, Pfizer said in a tweet on Thursday.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for kids to begin receiving the vaccines shortly afterwards. A rapid authorization of the vaccine in young kids could help mitigate a potential surge of cases this fall, with schools already open nationwide.

The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on Thursday. Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the Delta variant among unvaccinated people.

While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness. The vaccine is already authorized in teens aged 12-to-15 and fully approved for ages 16 and up, and has been shown to induce a strong immune response in the target age group in a 2,268 participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2-to-5 years and children ages 6 months-to-2 years, with data expected in the fourth quarter. (Reuters)

NEW DELHI, (ANI): The decision on Bharat Biotech’s Covid-19 vaccine, Covaxin Emergency Use Listing (EUL) by the World Health Organisation (WHO) is expected in October, informed the top health experts in the country on Saturday.

Speaking to ANI, the experts said that the approval of the vaccine shouldn’t be delayed after reviewing the data.

“Globally, the world is in need of vaccines and we have to ensure that this is a global war, and many countries are still not getting vaccinated. So we have to ensure that our vaccines should get the approval timely,” said Dr Naveet Wig, Chairperson of the COVID Task Force for AIIMS, Delhi.

“WHO will give the approval soon as it is a ‘killed vaccine’ which has been approved earlier also by other names from other countries,” he added.

Earlier on Friday, Dr Randeep Guleria, Director, AIIMS, Delhi said, “We are hopeful that now with all the data in and studies having been done it should happen soon rather than happening late.”

“The delay of Emergency Use Authorization (EUA) will affect Indians especially students and who has international travel plans. The EUA is important because, without EUA, Covaxin will not be considered and accepted around the world by most of the countries,” he added.

WHO’s Strategic Advisory Group of Expert on Immunization (SAGE) will be conducting a meeting on October 5 regarding EUL to Covaxin. (ANI)

WASHINGTON DC, (Reuters): Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in 5-11 year olds and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.

The U.S. Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months.

That could mean an authorization of the shot for children by the end of October, sources have told Reuters. A decision on the vaccine’s use in younger children is eagerly awaited by millions of Americans as coronavirus infections have soared in children to hit their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized for 12 to 15 year olds and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.

The Pfizer-BioNTech vaccine was authorized for the 12-15 age group roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide. While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. They also plan to submit data from the full late-stage trial for scientific peer-reviewed publication. The FDA was not immediately available for comment.

Data from the companies’ trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds.

The safety profile was also comparable to the older age group, Pfizer said. The drug makers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter.

Moderna’s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe.

Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said they did not see any instances of heart inflammation in the trial participants. (Reuters)

New Delhi, (PTI): Noting that COVID-19 may be heading towards endemicity in India, vaccinologist Dr Gangandeep Kang on Monday said local flare-ups that will be smaller and spread wider across the country may add up to form a third wave of the pandemic, but the scale will not be like before.

The endemic stage is when a population learns to live with a virus. It is very different from the epidemic stage when the virus overwhelms a population.

In an interview with PTI over the COVID-19 situation in India, Kang said after the second wave, maybe a quarter of the country’s population continues to be susceptible to the virus.

”So will we be able to achieve within that quarter the same numbers and the same patterns that we saw in the second wave? That I think is unlikely. What we will see is local flare-ups that will be smaller and spread wider across the country. Now if that will collect to form a third wave, that may happen if we have a lot of behaviour change around festivals, but the scale is not going to be anything like what we saw before,” she said.

Asked if Covid may be heading towards an endemic stage in India, Kang said, ”Yes.” ”When you have something that is not going to go away in the near future, it is heading towards endemicity. Right now, we are not looking at eradicating or eliminating SARS-CoV2, which means it has to become endemic,” Kang, who is a professor in the Christian Medical College, Vellore, said.

”We have a lot of endemic diseases like influenza, but you can have a pandemic layered on top of an endemic disease. So for example, if you get a new variant that completely escapes the immune response, you could have a pandemic again but that would not mean that SARS-CoV2 is only a pandemic and has stopped being endemic.

”There is both, because one set of variant will be doing something while another would be doing something else,” she explained.

Kang stressed on the need for developing better vaccines that can deal with new variants of Covid.

”We designed vaccines based on the ancestral variant of SARS-CoV-2. Is that the best possible vaccine we could have in terms of the quantity, quality and longevity of immune response? So will it be better for us to have a vaccine based on a newer variant, should we be thinking about combining the two — like one dose with the older variant and one with the new — what will that mean in terms of immune response? ‘

‘I think these are things for us to think about and we should focus on making the product — new variant-based vaccines, new platform vaccines — and test those very carefully in clinical trials, so we can maximise the value that vaccines bring. And we can only do that if we experiment enough of what we have and what we can potentially make,” she said.

Speaking about how the pandemic overwhelmed the medical system and affected other diseases, she said what needs to be done is rationalising the approach.

”What we need to do is rationalise our approach. What we did during the height of the pandemic is that we took people, laboratories, testing away from the regular medical system and devoted all these resources to COVID-19…we cannot be doing the same thing we did 18 months ago…we need to think that in the future, if we need to ramp up SARS-CoV2 activity, what will we do so that we will not lose what we lost this time around,” she said.

Kang said in many states, the maternal mortality rate went up because women did not get care, the immunisation programmes were affected, people with cancer did not get chemotherapy, those diabetic could not get medicines, the TB programme, which needs high compliance with therapy, struggled.

”What we need to do is build resilience in the healthcare system so we do not lurch from damage to damage,” she said.

She said the time has come to rethink about the attitude towards testing.

”I think we also need to change what we are measuring about COVID-19 and should measure what matters — what puts people in hospitals, what puts people in the risk of dying, not just the fact that the test is positive. And then, another thing to remember is that with any test, you can potentially have false positives…so the imperative to understand what testing is really showing us matters more and more now,” she added. (PTI)

Mumbai: Fully vaccinated people were three times less likely than unvaccinated persons to test positive for the Covid-19 infection, a new research study has found.

The study led by researchers at the Imperial College London is based on swab tests taken by nearly 98,233 people themselves at home and their samples were analysed by PCR testing between June 24 and July 12, news agency IANS reported.

Of these, 527 tested positive and 254 of these were successfully analysed in the lab to determine their origins, 100 per cent of which were Delta variants.

There is no specific mention of the vaccines in the IANS media report, that the tested persons had been given. Possibly the full report may mention it.

People who were unvaccinated had a three-fold higher prevalence than those who had received both doses of Covid vaccine, at 1.21 per cent compared to 0.4 per cent.

In addition, analyses of PCR test results also suggest that fully vaccinated people may be less likely than unvaccinated people to pass the virus on to others. This is due to having a smaller viral load on average and therefore, likely spreading less virus.

The study carried out in partnership with Ipsos MORI is available in a pre-print report and will be submitted for peer-review, the report said.

“These findings confirm our previous data showing that both doses of a Covid vaccine offer good protection against getting infected. However, we can also see that there is still a risk of infection as no vaccine is 100 per cent effective, and we know that some double vaccinated people can still fell ill from the virus,” said Paul Elliott, School of Public Health at Imperial College London.

“So even with the easing of restrictions, we should still act with caution to help protect one another and curb the rate of infections,” he added.

The study showed that the highest infection prevalence was found in young people aged 13-24 years at 1.56 per cent or 1 in 65 infected, while the lowest was in people aged above 75 years at 0.17 per cent. Women had a lower risk of testing positive than men (0.55 per cent vs 0.71 per cent).

Previous study data showed that the link between infections, hospitalization and deaths had been weakening since February.

However, since mid-April, the trends between infections and hospitalization were growing closer together again, although to a smaller extent for deaths. This could reflect the switch from Alpha to Delta, and a changing mix (towards younger and unvaccinated people) of hospitalized cases, the researchers said.

Source: IANS

New Delhi, (Reuters): The Central Drugs Standard Control Organisation said on Monday that Johnson & Johnson withdrew its proposal seeking accelerated approval of its COVID-19 vaccine in the country, without giving additional details.

The US-based company had said in April it was seeking an approval to conduct a bridging clinical study of its Janssen COVID-19 vaccine candidate in India. Trials in the United States at that time were paused on reports of rare blood clots.

The drug maker’s withdrawal comes as India tackles legal challenges with manufacturers over indemnity issues, with its junior health minister saying last week that a team had been formed to engage with vaccine makers.

“This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity,” Bharati Pravin Pawar had said.

Johnson & Johnson and the Central Drugs Standard Control Organisation (CDSCO) did not immediately respond to Reuters’ requests for comments on why the company withdrew its application.

As of July 31, Johnson & Johnson is yet to request a full approval for its shot with the U.S. FDA, while Pfizer Inc, BioNTech SE, and Moderna Inc have already sought full approval of their vaccines with the FDA.

In India, the drug regulator had given emergency use authorisation to Moderna’s vaccine in June.

MUMBAI: (Indian Express) Scientists in India are keeping a close watch on the Delta Plus variant, a mutated version of the Delta variant of the SARS-CoV2 coronavirus. While the transmissibility of Delta Plus is being monitored and lab tests are underway to check vaccine effectiveness, experts have said Delta Plus does not appear to be more infectious than Delta.

What is Delta Plus variant of Covid-19?
The Delta variant, or B.1.617.2, has been largely responsible for driving the second wave of coronavirus infections, and was first identified in India. It has since mutated into the variants AY.1 and AY.2.

These sub-lineages are called Delta Plus as the Delta variant has developed additional mutations of possible importance, said Dr Anurag Agrawal, director of CSIR-Institute of Genomics and Integrative Biology. “There is a need to understand the continued evolution of the B.1.617.2 lineage of SARS-CoV2,” said Dr Sujit Singh, chief of the National Centre for Disease Control.

Delta Plus has been formed as a result of Delta acquiring a mutation called K417N in the spike protein. The K417N mutation, carried by both AY.1 and AY.2, is also found in the Beta variant or B.1.351, first reported in South Africa and classified as a variant of concern by the World Health Organization (WHO).

Where has this sub-lineage been detected?
Scientists said that initially, a small number of sequences of Delta (B.1.617.2) carrying the K417N were found on the Global Initiative on Sharing All Influenza Data (GISAID). The earliest sequences were attributed to Europe through routine scanning of variation in Delta.

A report by Public Health England in the first week of June mentioned 63 genomes of Delta with K417N as identified on GISAID. These 63 genomes included one each in Canada, Germany and Russia; six in India; nine in Poland; two in Nepal; four in Switzerland; 12 in Portugal; 13 in Japan and 14 in the US.

Is Delta Plus a variant of concern?
While the WHO lists Delta as a variant of concern, the Indian government has classified Delta Plus (AY.1) as a variant of concern in the country. Dr Agrawal said any Delta sub-lineage is a variant of concern that needs to be investigated further.

While prevalence of Delta Plus is low in India, scientists are wary of the fact that some mutations help the virus become either more transmissible, or more virulent, or both. As both AY.1 and AY.2 are descendants of Delta , they are likely to share some properties of the Delta variant, such as transmissibility. Also, the K417N mutation is present in the Beta variant, which is reported to have shown immune escape and could dodge antibodies.

In terms of spread, how does Delta Plus compare with Delta?
“Studies are under way, but at present we cannot say there is an increase in transmission of the Delta Plus variant based on genomic data or lab studies,” Dr Singh said.

Dr Agrawal said Delta Plus is not rising faster than the Delta variant. However, the Centre is keeping a close watch. Delta Plus cases have been found across 12 states, and public health response has been stepped up by enhancing testing, quick contact tracing and priority vaccination.

According to INSACOG, a consortium of 28 labs set up by the Health Ministry to carry out genome sequencing of the virus, among the 45,000 samples from across 12 states that have been sequenced, some 48 have been found with the mutated variant, as per a media briefing on June 25.

Leading immunologist Dr Vineeta Bal stressed the importance of understanding how transmissible this variant could be. “We need to test the Delta Plus variant in tissue culture and compare it with the original Wuhan virus and the Delta variant to evaluate relative efficiency to enter cells expressing ACE-2 receptors. Whether it is more efficient or not in spreading the infection can then be extrapolated to speculate on its transmissibility,” she said.

In Maharashtra, where 21 cases were reported, Dr Pradeep Awate, state surveillance officer said they have identified 20 persons infected with Delta Plus (there has been one death). “Our investigations are underway, but there has not been an alarming rise in cases. The focus is on tracing the contacts of the index cases apart from stepping surveillance of Influenza-like illness cases in these areas and monitoring breakthrough and re-infection cases,” he said.

Can vaccination at the current rate offer protection from these?

By now, India has given one dose to at least 19% of the population and both doses to 4%, leading virologist Prof Shahid Jameel said. Also, the rate of vaccination has doubled over the last week from an average of 3 million to over 6 million doses per day.

Experts note that even one dose of Covishield is over 70% effective in protecting from severe disease and hospitalisation against the Delta variant. But as far as Delta Plus in concerned, trends are unclear at present.

“We have to wait for more data on the mutated variant,” Dr Soumya Swaminathan, WHO chief scientist, told The Indian Express. “Vaccines are effective as of now against all variants in preventing severe disease and death. We will need more data from effectiveness studies. The good thing is that there are very few cases that have been described globally and we need to keep a close watch on this,” Dr Swaminathan had said earlier during a organised by the WHO.

Dr Bal said “the virus has to be grown and tested on the serum samples from those who are infected and recovered, and those who have been completely vaccinated to check whether the antibodies present in the serum samples can `neutralise’ the virus by comparing with a reference strain”.

Is any extra precaution needed against this variant?
Double-masking, vaccination and zero tolerance for non-adherence to Covid-appropriate behaviour are extremely important, said Dr Shashank Joshi, an expert member of the Maharashtra Covid task force. “We cannot afford to be casual now,” Dr Shashank Joshi said.

According to Dr Anita Mathew, Mumbai-based infectious diseases specialist with Fortis Hospital, it is important to maintain physical distance and hand hygiene practices. The way forward is to keep a close watch on its potential presence in the country and ensure appropriate public health response, Dr Mathew said.

Prof Jameel noted that there is no answer to when or not a third wave can hit the country. “All would depend upon how we follow Covid-appropriate behaviour as the country opens up, how quickly we can provide good single dose vaccine coverage, and whether a far more infectious variant emerges as a driver.”

New Delhi | Reuters: The Indian government doubled the gap between the two doses of the AstraZeneca COVID-19 vaccine without the agreement of the scientific group that it said recommended the increase, three members of the advisory body told Reuters.

The ministry of health announced the decision to change the gap from 6-8 weeks to 12-16 weeks on May 13, at a time when supplies of the shot were falling short of demand and infections were surging across the country.

It said the extended gap was recommended by the National Technical Advisory Group on Immunisation (NTAGI), based on real-life evidence mainly from Britain. Yet the NTAGI scientists, classified by the government as three of the 14 “core members”, said the body did not have enough data to make such a recommendation.

M.D. Gupte, a former director of the state-run National Institute of Epidemiology, said the NTAGI had backed increasing the dosing interval to 8-12 weeks – the gap advised by the World Health Organization. But he added that the group had no data concerning the effects of a gap beyond 12 weeks.

“Eight to 12 weeks is something we all accepted, 12 to 16 weeks is something the government has come out with,” he added. “This may be alright, may not be. We have no information on that.”

This was echoed by his NTAGI colleague Mathew Varghese, who said the group’s recommendation was only for 8-12 weeks.

The health ministry, citing the head of NTAGI’s working group on COVID-19, said that the dosing decision was based on scientific evidence. “There was no dissenting voices among the NTAGI members,” the ministry said on Twitter.

The ministry’s statemen on May 13 said that it had accepted the 12-16 weeks recommendation from NTAGI’s COVID working group, as had a group of mainly government officials tasked with vaccine administration, known as NEGVAC.

Government health officials told a news conference on May 15 the gap was not increased to address a vaccine shortage but was a “scientific decision”.

J.P. Muliyil, a member of the seven-strong COVID working group, said there had been discussions within the NTAGI on increasing the vaccine dosage interval but that the body had not recommended 12-16 weeks.

“That specific number was not quoted,” he said, without elaborating.

N.K. Arora, the COVID working group head, declined to comment to Reuters on its recommendations but said all its decisions were taken collectively by the NTAGI at large.

A NEGVAC representative said it “respects the decisions of the NTAGI and use them for our work”, declining to elaborate.

Real-world data released early last month by South Korea showed that one dose of the vaccines from AstraZeneca and Pfizer was 86.6% effective in preventing infections among people aged 60 and older.

Muliyil said this increased confidence within the advisory body that delaying a second shot would not be harmful.

The AstraZeneca vaccine accounts for nearly 90% of the 257.5 million vaccine doses administered in India.

The dispute over doses comes amid criticism from some scientists that the government had been slow to respond to a new virus variant that led to a spike in infections in April and May.

The government has denied being slow to react, saying state-run laboratories had studied variants in real time and shared data with local authorities to allow them to take the necessary action.

Shahid Jameel, a top Indian virologist who recently quit a government panel on virus variants after criticising New Delhi over its response to the pandemic, said the authorities should clarify their position on the reasons for the decision to double the gap between doses.