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Benefits of Pfizer child shot likely outweigh risks, FDA says

The staff of the Food and Drug Administration said the benefits of

Pfizer

Inc. and BioNTech SE’s Covid-19 vaccine for young children likely outweigh its risks, ahead of a meeting next week where experts will weigh whether the shot should be cleared for use.

According to the staff report, which was posted on the FDA website late Friday, the vaccine’s capacity to prevent hospitalizations and deaths likely exceed the risk of adverse outcomes such as the heart condition myocarditis, which has been reported in some younger males who have received messenger RNA shots for Covid-19.

Pfizer and BioNTech earlier this month asked the FDA to grant an emergency authorization for children age 5 to 11 to receive its vaccine. The formulation for young kids is one-third the dose of the adult shot.

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Tuesday to evaluate the data and hear presentations from the company and health officials. The group, made up of outside scientific experts, will then make a recommendation on whether to grant an authorization.

The staff report made no explicit recommendation as to whether the advisers should support authorization. If the panel votes to back a clearance and the FDA agrees, it could pave the way for kids to begin getting shots by early to mid-November.

Clearing a vaccine for elementary-school age children would mark a major milestone in the pandemic. It is like to provide peace of mind for many concerned parents and for kids themselves, and could open the door to resume activities that have been on hold since Covid-19 first began to spread in the U.S.

However, in contrast to the initial wave of demand for shots when they were first cleared for adults, there is evidence that some parents could be slower to get shots for their children.

A poll conducted by the Kaiser Family Foundation in September, before Pfizer first revealed results from its trial of the 5-11 vaccine, found only about 34% of parents would vaccinate their kids right away when a shot was authorized for the age group.

High Effectiveness
The FDA also posted documents from Pfizer on Friday in which the drug company said that the reduced-dose vaccine was 90.7% effective at preventing symptomatic disease in kids in a study.

Additionally, data from an additional 2,250 children enrolled in the trial as part of an expansion requested by regulators found no new safety problems.

The staff report said that side effects for younger children were similar to older groups who had received the shot, and included pain at the injection site, redness and swelling. Reactions such as fever, fatigue, headache, chills, and muscle pain were generally reported less frequently and were milder than in people 12 and older.

The FDA’s myocarditis risk-benefit estimates in young kids were based on modeling various scenarios for Covid incidence and assuming an 80% efficacy of the shot preventing hospitalization in young kids, similar to the real-world efficacy in adults during the period when the delta variant was circulating.

In the efficacy portion of the trial, 1,305 kids without prior evidence of Covid-19 received two shots, while 663 got placebo injections. Among those who got the vaccine, there were three cases of symptomatic disease starting a week after the second shot, compared with 16 cases in the placebo group.

Symptoms were milder in the cases that occurred among vaccinated kids, with none developing fevers. Most of the cases occurred in August and September, when the delta variant was becoming the dominant strain of the coronavirus in the U.S.

WHO: Europe had most COVID-19 cases, deaths over last week

Europe stood out as the only major region worldwide to report an increase in both coronavirus cases and deaths over the last week, with double-digit percentage increases in each, the United Nations’ health agency said on Wednesday.

The World Health Organization said that cases in its 53-country European region, which stretches as far east as several former Soviet republics in central Asia, recorded an 18% increase in COVID-19 cases over the last week – a fourth straight weekly increase for the area.

In WHO’s weekly epidemiological report on COVID-19, Europe also saw a 14% increase in deaths. That amounted to more than 1.6 million new cases and over 21,000 deaths.

The United States tallied the largest number of new cases over the last seven days — nearly 513,000 new cases, though that was a 12% drop from the previous week – and over 11,600 deaths, which was about the same number as the previous week, WHO said.

Britain was second at more than 330,000 new cases. Russia, which has chalked up a series of national daily records for COVID-19 deaths in recent days, had nearly a quarter million new cases over the last week.

WHO officials have pointed to a number of factors including relatively low rates of vaccination in some countries in eastern Europe. Countries including Ukraine, Romania, Bulgaria, Moldova and Georgia had some of the highest rates of infection per 100,000 people in the last week.

Overall, WHO’s vast Americas region – which has tallied the most deaths of any region from the pandemic, at more than 2.7 million – saw a 1% uptick in deaths over the last week, even as cases fell by nine percent. Cases in WHO’s southeast Asia region, which includes populous countries like India and Indonesia, fell 8 percent even as deaths rose 13 percent over the last week.

UAE lifts ban on entry from certain countries for vaccinated residents, including India

The United Arab Emirates has lifted its Covid-19 induced travel ban from more countries, allowing residents who have been fully vaccinated with a shot approved by the World Health Organization to return as of September 12 .

Dubai, one of the seven emirates, is due to open the Expo 2020 world fair on October 1 after a year-long delay due to the pandemic. The regional business and tourism hub is relying on the fair to give its economy a boost.

Organisers had previously said they expect remaining UAE flight restrictions imposed to curb coronavirus infections to be lifted in time for Expo 2020.

Countries that are now in the clear are India, Pakistan, Bangladesh, Nepal, Sri Lanka, Vietnam, Namibia, Zambia, Democratic Republic of Congo, Uganda, Sierra Leone, Liberia, South Africa, Nigeria and Afghanistan.

However, it might not be as smooth as just taking a flight back. Approval must be sought from the UAE government to return, and various PCR tests must be taken.

NRI-QR-labelET Online

Comorbid children will need a doctor certificate for shot

Children with comorbidities will need a certificate from a doctor to avail of the Covid-19 jab, a senior government official told ET, as India gears up to start inoculating children from next month. Based on the recommendations of the Covid working group, guidelines on vaccinating children with underlying medical conditions will be issued soon, he said.

The list is expected to include children with haematological, neurological, cardiac, liver, gastrointestinal, rheumatic, cancer, respiratory and developmental disorders. “The standing technical sub-committee of the NTAGI (National Technical Advisory Group on Immunisation) has held several meetings with top paediatricians and will issue the guidelines soon,” the official said.

The committee members are of the view that a certificate prescribed by a doctor would be mandatory to get children vaccinated. While the committee is looking at ways to make it easier for parents to get the certificate, it also wants to ensure that fake certificates are not issued.

“There are various issues that the committee is looking into; for example, who will certify it, how to make it simpler and how to ensure that false certificates are not issued,” said the official.

IMA hails PM Modi, healthcare workers as India’s administered vaccine doses cross 100-crore mark

New Delhi, The Indian Medical Association (IMA) hailed Prime Minister Narendra Modi and healthcare workers as the country achieved a major milestone in its vaccination programme against COVID-19 with total administered doses surpassing the 100-crore mark on Thursday. When many countries including western ones were witnessing more than 2.5 per cent COVID-19 mortality rate, India with its “altruistic leadership, passionately obligated” modern medical manpower and synchronised efforts of the ministry of health fostered the country’s healthcare and kept the mortality under 1.4 per cent throughout the pandemic, the IMA said in a statement.

“COVID-19 struck us in an unprecedented way resulting in heartbreaking casualties of both the public, nearly 2,000 doctors, and many political leaders too,” the doctors’ body said.

“Though there were many challenges on bed availability, oxygen shortage, drugs, and misinformation campaigns, which were effectively managed by the proactive leadership of the prime minister, the acme of accomplishment was the approval and roll-out of vaccination on January 16,” it stated.

When many raised concerns on the safety and efficacy of vaccines, the IMA said its leaders proactively propagated positively and voluntarily took the jabs on the first day.

“IMA salute the modern medical manpower who had taken this nationalistic task on their shoulders as a priority task, reaching out to the unreached and making the vaccination reach 1 billion needy people, with the Government of India giving it free of cost to the people,” it said.

The association in its statement also appreciated the steps taken by the government task force to monitor post-vaccination symptoms and complications, their early detection and mitigate the negative propaganda.

“IMA constituted a special cell to monitor the outcome through the pharmacovigilance team and happy to note India is free from any untoward major incidents, though we have vaccinated the world’s largest number today. Many doubting people with vested interest tried their best to promote negativism on vaccinations, the firm steps of our prime minister and the voices of IMA could scuttle their efforts to ensure today we are the world’s largest vaccinators with indigenous production,” the statement said.

Nearly 10 lakh people, who are due for a second dose have not taken the vaccination and special care must be taken to reach out to them also, the doctors’ body said.

“We appeal to all to follow Covid appropriate behaviours by wearing proper masks and avoiding massive gatherings. IMA requests the government not to loosen the grip and ensure mass gatherings are prevented,” the statement said.

Colin Powell has died of COVID-19 complications, family says

Colin Powell, former Joint Chiefs chairman and secretary of state, has died from COVID-19 complications, his family said Monday.

In an announcement on social media, the family said Powell had been fully vaccinated.

“We have lost a remarkable and loving husband, father and grandfather and a great American,” the family said.

( Originally published on Oct 18, 2021 )

In Video: Colin Powell, who shaped US National Security, dies at 84; remembered as patriot and statesman

US’ work with India on vaccine manufacturing saving people’s lives, says DFC chief

India is a “vaccine powerhouse” and America’s work with the country in vaccine manufacturing is saving people’s lives, the head of the US International Development Finance Corporation, David Marchick, has said ahead of his India visit.

The United States International Development Finance Corporation (DFC) is America’s development bank, which invests in developing countries around the world.

Leading a high-powered delegation, DFC Chief Operating Officer (COO) Marchick would travel to India from October 24 to 26.

India is the most important and largest partner for DFC investment amounting to more than USD 2.3 billion, which is almost eight per cent of its overall exposure, Marchick said ahead of his India visit beginning Sunday.

“We have a very ambitious pipeline. We are very, very excited to work with India to drive economic development and strengthen the partnership between the United States and India,” Marchick told PTI in a recent interview.

The DFC COO is currently visiting South Africa, from where he is scheduled to travel to India.

“Normally the DFC’s work lifts up people’s lives. Our work with India on vaccine manufacturing is saving people’s lives,” he said in response to a question.

During his India trip, Marchick is scheduled to travel to Hyderabad where he will visit the offices of the Indian vaccine manufacturer Biological E and participate in a signing ceremony to open a new facility with substantial capacity for vaccine manufacturing.

“India is a vaccine powerhouse. It has very innovative and productive companies in the space. They’re producing huge numbers of vaccines,” he said. At the same time, he noted that the world needs additional capacity.

“India is an absolutely critical part of the solution for the pandemic, given that it is a vaccine powerhouse,” Marchick said, underlining that India reaching the milestone of one billion doses is extraordinary.

India scripted history on Thursday with the cumulative COVID-19 vaccine doses administered in the country surpassing the 100-crore milestone.

Prior to the start of the pandemic, total vaccine manufacturing capacity around the world was around five billion. That’s for all vaccines, including for polio and yellow fever.

“We need somewhere in the range of 11 billion doses of manufacturing capacity around the world for COVID alone. So, India can play a huge role in filling that gap. And the DFC, the Biden administration, is using its tools to help expand vaccine manufacturing in India and around the world to help get shots in arms,” Marchick said.

This work is in advancement of the historic commitment set out by President Joe Biden and his counterparts in the ‘Quad’ — Australia, India, Japan and the US.

On September 24, Biden hosted the first-ever in-person summit of Quad leaders at the White House. At President Biden’s invitation, Prime Minister Narendra Modi and his counterparts Scott Morrison from Australia and Yoshihide Suga from Japan had attended the Quad summit.

After the conclusion of the summit, the Quad leaders in a joint statement had said that in addition to doses financed through COVAX, the four-nation bloc has pledged to donate more than 1.2 billion doses globally of safe and effective COVID-19 vaccines and has so far delivered nearly 79 million safe, effective, and quality-assured vaccine doses to countries in the Indo-Pacific as part of those commitments.

Observing that American healthcare experts are in regular touch with the Indian authorities and companies to provide technical assistance, the COO said the DFC provided financing of about USD 50 million for a new facility to be built for Biological E and a new factory, which will substantially expand its capacity to allow it to manufacture in excess of a billion doses.

In addition to helping India expand its vaccine manufacturing capacity, DFC has been a major investor in India’s other sectors as well, he said.

“We’re a huge investor in India. We have USD 2.3 billion of investments already. We have a significant pipeline of over USD 1 billion. So, we would be one of the larger investors in India. Our goal is to catalyse private sector financial activity,” he said.

DFC, he said, is particularly focused on four sectors: climate, health, equity and gender opportunities and then technology. These are obviously four critical areas for the development of India’s economy, Marchick observed.

On climate, obviously the president (Biden) has said that climate is an existential threat. “India is a linchpin in having the world address the climate crisis,” Marchick said, adding that Prime Minister Narendra Modi is seized with the issue and India “has the most ambitious renewable energy strategy of any country in the world” and we want to help and be a solution provider for that.

On gender equity, DFC’s main goal is to provide financing for small and medium sized enterprises that are run by women, are owned by women. “We have partnered with a number of financial institutions in India to provide them with liquidity and capital, which they can then lend to small and medium sized enterprises in India,” the COO said.

“In technology, obviously India is a powerhouse and we provide financing for various technology missions,” Marchick said. However, the main reason for the trip is vaccine and vaccine manufacturing. PTI LKJ SCY AKJ SCY SCY

Vaccine rollout: Education ministry roped in to build confidence in safety of vaccines

New Delhi: Days before the vaccine rollout, the Union health ministry has sought the support of several stakeholder ministries including the education ministry to build “public confidence” on vaccine safety and address fears over “any adverse event”.

In a communication to the Union education ministry, health secretary Rajesh Bhushan has stressed the need to address public expectations, anticipation as well as “any hesitancy” through a concerted public outreach, and sought the support of university networks, online talk platforms and any leverage points of large footfalls to drive and support a vaccine campaign.

In a swiftly evolving scenario of vaccine development and rollout, one of the key challenges is to ensure that the billion plus population of India gets “factually correct information and updates on vaccine benefits” and rollout progress, he wrote in the communication dated January 5.

“It is critical to build public confidence regarding vaccine safety and address fears over any adverse events, and at the same time to continue stress on strict public adherence to Covid-appropriate behaviour,” the health secretary wrote.

The government needs to build an environment of “universal vaccine acceptability” through active collaboration and the key to it will be an “effective communication plan” to disseminate information at all levels, from state to district, block, village and the family level, he has said in communications to Secretaries of various ministries.

The health ministry has requested that the huge network of field networks including educational institutes to collaborate with it to ensure ‘maximum outreach’ across all states and union territories to disseminate special information, education and communication (IEC) material on the vaccine.

It has prepared the IEC material and shared them with the education ministry for vaccine advocacy campaign. The health ministry is learnt to have written to several other stakeholder ministries as well to help disseminate the message in various groups and communities.

The ministry has also reinforced its readiness for the rollout of the vaccination programme but pointed out that initially the vaccine will be available in limited stocks. As advised by the National Expert Group on Vaccine administration for Covid-19 (NEGVAC), the first prioritisation in initial phases will be for healthcare and frontline workers, persons aged 50 years and above, and those below 50 years of age but with comorbid conditions.

Serum Institute to be ready with coronavirus vaccine by 2022

PUNE: City-based Serum Institute of India (SII) on Wednesday said it expects to be ready with a vaccine against the novel coronavirus (COVID-19) by early 2022.

SII announced that a vaccine candidate for the novel coronavirus, which has killed more than 2,000 people in China since its outbreak in December-end, is expected to progress to human trial phase within the next six months.

“The vaccine candidate, developed by SII in partnership with American biotechnology firm Codagenix, has progressed to the pre-clinical test phase (the animal trial phase) and we hope to be ready with the vaccine by early 2022,” SII CEO Adar Poonawalla said in a statement here.

“The combined efforts with the team at Codagenix have borne fruit and we hope to save millions of lives with this vaccine,” he said.

The statement said since the novel coronavirus has affected the lives of thousands of people on the planet, a preventive measure has become a necessity.

“While several efforts have been made to finding a cure as well as in controlling the outbreak, this is the first vaccine-virus strain to progress to the pre-clinical trial phase,” the company said.

The vaccine-virus strain is identical to the original virus and can generate a robust immune response, Poonawalla said.

The vaccine-virus strain will be the fastest such Made in India vaccine to progress to the human trials phase within six months, he said.

The cost of the project is up to Rs 300 crore, for which SII aims to secure external funding via various global partners, he said.

Poonawalla said they are in talks with several firms across the globe for potential partnerships.

“We are not excluding China as a potential site for our clinical trials. By August-end, we will have data on mice and primates to submit to regulatory authorities to enter into the human trials phase,” he said.

SII is the world’s largest vaccine manufacturer by a number of doses produced and sold globally, with more than 1.5 billion doses so far.

BCG vaccine not recommended for virus: WHO

New Delhi: The World Health Organization (WHO) has said it does not recommend the BCG vaccination for prevention of Covid-19. The statement gains significance for countries including India, where some states are considering using the BCG vaccine for clinical trials on Covid-19 patients.

“There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with Covid-19 virus,” the WHO said in a statement on April 12 in response to reports that countries where the vaccine for tuberculosis was used have a lower incidence of coronavirus infections and deaths. “In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of Covid-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of TB,” it said.

Agencies

The statement noted that a “persion of local supplies may result in neonates not being vaccinated, resulting in an increase of disease and deaths from tuberculosis.” It said that two clinical trials are under way to address this issue and WHO will evaluate the evidence when it is available. “There is experimental evidence from both animal and human studies that the BCG vaccine has non-specific effects on the immune system. These effects have not been well characterised and their clinical relevance is unknown,” it said.

The WHO said that while it has been observed that countries that routinely used the vaccine in neonates had less reported cases of Covid-19 to date, such studies are prone to significant bias from many variables, including differences in national demographics and disease burden, testing rates for coronavirus infections and the stage of the pandemic in each country.