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EU regulators advocates use of Pfizer-BioNTech vaccines for adolescents

by Medically Speaking Team
written by Medically Speaking Team

After United States and Canada, Europe’s medicines regulator today endorsed the use of Pfizer’s COVID-19 vaccine for children who are as young as 12 years of age.

The European Medicines Agency’s endorsement comes weeks after it began evaluating extending use of the vaccine, developed with Germany’s BioNTech, to include 12- to 15-year old’s. It is already being used in the European Union for those aged 16 and older

Earlier this month, US-based Centers for Disease Control approved the use of the vaccine for the children in the age group of 12-15 years.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 14 to 0, with one recusal to support the two-dose vaccine’s emergency authorization after it was cleared by the Food and Drug Administration, a Bloomberg report stated. CDC Director Rochelle Walensky adopted the recommendation after the vote, according to a statement from the agency

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Two Covid vaccine doses needed for protection against variant from India: Report

by Medically Speaking Team
written by Medically Speaking Team

Both doses of two-dose regimen Covid-19 vaccines are needed to provide strong protection against symptomatic infection from the virus variant first identified in India, according to a Financial Times report based on UK government research. The B.1.617.2 variant has raised severe concern around the world as health experts are increasingly wary about the vaccine efficacy against the new variant which has now become the second most dominant variant in Britain after B.1.1.7 strain. The United Kingdom has detected 3,424 cases of B.1.617.2 variant across the country as of May 12.

Public Health England (PHE) data on vaccine efficacy, presented on Friday to the government’s New and Emerging Respiratory Virus Threats Advisory Group (Nervtag), suggested that two vaccine doses provide 81 per cent protection against the B.1.617.2 variant, reported FT, quoting two officials briefed on the preliminary data. One dose of the Covid-19 vaccine offered 33 per cent protection against the virus variant, per FT.

The data from the Oxford-AstraZeneca and Pfizer-BioNTech vaccines showed that while a single Covid shot offered 51 per cent protection against the B.1.1.7 variant, both doses provided 87 per cent protection. This means a single dose of Covid vaccine provides 35 per cent less protection against B.1.617.2 as compared with the variant first detected in the UK.

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BioNTech says vaccine likely to be effective against Indian variant

by Medically Speaking Team
written by Medically Speaking Team

BioNTech SE said yesterday that the COVID-19 vaccine it developed with Pfizer should be roughly as effective against the new coronavirus variant first detected in India as it has been shown to be against the South African variant.

The company said in a statement that Ugur Sahin, Chief Executive Officer, felt encouraged by recent findings in a scientific paper based on blood analysis of vaccinated individuals, which showed that the antibodies elicited by the vaccine were able to neutralise the Indian variant.

Since the blood tests on the variant that was first detected in South Africa had shown similar results, promising real-world data on the vaccine’s effectiveness against the South African variant of about 75 per cent led him to believe that its actual effectiveness against the Indian variant “might be in the same range.”

“So far, we’ve had the chance to test our vaccine against more than 30 variants of the virus. It has proven effective against mutations so far,” Sahin said earlier, speaking on Turkish television.

He added, “We expect (our vaccine) to protect against infections by 70 to 75 per cent,” he said on TV, in what the company later said was in reference to the South African variant and not directly to the Indian variant.

Since the concerning COVID-19 variant, known as B.1.617.2, was first identified in India, it has ravaged that country and spread to at least 26 nations out of the 53 in the World Health Organization’s (WHO) European region, the organisation said.

The WHO’s regional director said yesterday that COVID-19 vaccines being deployed in Europe, including the Pfizer/BioNTech shot, appear able to protect against circulating virus variants that have caused concern because they are more easily transmitted.

Sahin was speaking with Turkish Health Minister Fehrettin Koca, who separately said the country recorded less than 10,000 daily new coronavirus cases for the first time since 1st March.

Turkey, which briefly was second globally last month in new infections, is using the Pfizer/BioNTech vaccine as well as China’s Sinovac Biotech shot in its vaccination programme.

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Pfizer, Moderna vaccines found to be effective against Covid variants, says study

by Medically Speaking Team
written by Medically Speaking Team

The Pfizer/BioNTech and Moderna coronavirus vaccines appear to protect against Covid variants B.1.617 and B.1.618 first identified in India, researchers have reported in a new pre-print paper, which has not yet been peer-reviewed, reported CNN.

Based on lab experiments, involving cell cultures, the B.1.617 and B.1.618 variants seem to be partially resistant to the antibodies elicited by vaccination.

“Thus, there is a good reason to believe that vaccinated individuals will remain protected against the B.1.617 and B.1.618 variants,” the researchers from New York University wrote in their paper. But more research is needed to determine just how effective the Pfizer/BioNTech and Moderna vaccines are against those variants in the real world.

The new research involved serum samples collected from eight people who recovered from Covid-19, six people fully vaccinated with Moderna’s vaccine. The researchers analyzed in lab experiments how the serum samples neutralized lentiviruses – a type of retrovirus – equipped with the same mutations as the B.1.617 and B.1.618 coronavirus variants.

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BioNTech to build mRNA manufacturing site in Singapore

by Medically Speaking Team
written by Medically Speaking Team

BioNTech said on Monday it plans to set up a regional headquarters and build a new manufacturing site for its vaccines based on Messenger RNA technology (mRNA) in Singapore, in the latest move to expand its production network.

The BioNTech company said its expansion plans were supported by the Singapore Economic Development Board and would increase the global supply of mRNA-based vaccines and establish a production facility in south east Asia to respond rapidly to future pandemics.

“Having multiple nodes in our production network is an important strategic step in building out our global footprint and capabilities,” said Ugur Sahin, CEO and Co-founder of BioNTech.

Governments around the world are looking to build up local vaccine production to secure access to supplies after manufacturing setbacks have slowed the rollout of Covid-19 doses in some countries.

BioNTech plans to open the Singapore office in 2021 and expects the manufacturing site will be able to produce.

The establishment of a south east Asia regional hub comes after BioNTech, based in Mainz, Germany, set up a U.S. headquarters in Cambridge, Massachusetts in 2020.

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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine

by Medically Speaking Team
written by Medically Speaking Team

Pfizer and BioNTech SE today announced the initiation of Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent Covid-19 in individuals, years of age and older.

Data to support the BLA will be submitted by the Companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The Pfizer-BioNTech COVID-19 vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the Companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. 

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

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EU to receive 50 mn doses of Pfizer after Denmark bans Astra over clot issue

by Medically Speaking Team
written by Medically Speaking Team

On Wednesday, the European Union said that it would get 50 million Pfizer vaccine doses earlier than expected after Denmark banned use of AstraZeneca over blood clot links.

The news broke out after U.S. drugmaker Johnson & Johnson delayed its Covid-19 shot among rising caseloads. Referring to the delay, EU Commission chief Ursula von der Leyen said “there are still many factors that can disrupt the planned delivery schedules of vaccines.”

The EMA said J&J was in contact with national authorities and recommended storing doses already received until the safety committee issued an expedited recommendation, reports Reuters.

Europe will receive BioNTech/Pfizer vaccine doses in the second quarter of this year and the delivery will start as soon as this month.

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Pfizer vaccine safe for adolescents, reveals data

by Medically Speaking Team
written by Medically Speaking Team

Pfizer vaccine has shown 100% efficacy in a phase III trial in adolescents aged 12 to 15 years old, Pfizer and BioNTech revealed in their data for their Covid-19 vaccine.

The companies are now planning to submit the data to the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) to extend the use of the vaccine for this age group “as quickly as possible” and for scientific review and potential publication.

“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, chairman and chief executive officer of Pfizer.

“We plan to submit these data to FDA as a proposed amendment to our emergency use authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year,” he added.

Pfizer and BioNTech will also continue to monitor the participants for long-term protection and safety for an additional two years after their second dose.

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Pfizer and BioNTech launch trials of Kids for COVID-19 Vaccine

by Medically Speaking Team
written by Medically Speaking Team

The Pfizer and German partner BioNTech SE has started testing their COVID-19 vaccine in children those who are under 12.

“The first volunteers in the early -stage trials were given their first injections on Wednesday,” said Pfizer spokesperson Sharon Castillo

Pfizer Inc.@pfizerWe, together with @BioNTech_Group, are proud to announce the start of a global study to evaluate the safety, tolerability, and immunogenicity of our #COVID19 vaccine in healthy children. Learn More: https://on.pfizer.com/3fbozbD

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