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US signs pact with Pfizer to donate 500 Mn doses to over 90 countries

by Medically Speaking Team
written by Medically Speaking Team

The United States President Joe Biden’s administration has closed a deal with Pfizer for 500 million doses of its COVID-19 shot, which will be donated to over 90 countries over the next two years.T

he United States is likely to distribute 200 million doses this year and another 300 million in the first half of next year to 92 lower-income countries and the African Union, Reuters reported citing sources.

As per reports, the deal was closed just ahead of Biden’s first trip abroad since taking office, an eight-day mission to rebuild trans-Atlantic ties strained during the Trump era and to reframe relations with Russia.

The donations will go through the World Health Organization and the Global Alliance for Vaccines and Immunization’s (GAVI) COVAX vaccine program that distributes COVID-19 shots to low- and middle-income countries.

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Covid: Pfizer vaccine produces nearly six times lesser antibodies against delta variant, shows study

by Medically Speaking Team
written by Medically Speaking Team

The coronavirus vaccine developed by pharmaceutical company Pfizer is likely to produce 5.8 times lower levels of antibodies against the Delta variant of the infection, according to a research published in the medical journal Lancet on Thursday. The Delta variant was first detected in India.

The study, which was conducted on participants who had received both doses of the vaccine, also showed that the levels of antibodies generated decrease with age and they decline over time. This observation makes a case for a booster dose of the vaccine. However, no correlation was observed for a person’s gender or body mass index.

The study analysed antibodies in the blood of 250 healthy people who received either one or two doses of the Pfizer-BioNTech Covid-19 vaccine, up to three months after their first dose. The Pfizer vaccine is expected to be available in India soon and is likely to be available for children as well.

The B.1.617.2 variant, now known as Delta, was responsible for the devastating second wave of the pandemic in the country, a government study has shown. Meanwhile, On Tuesday, the World Health Organization said that only the B.1.617.2 strain in India was now considered “of concern”.

‘Prior infection cuts infection risk for up to 10 months’

Meanwhile, a separate study published in Lancet has shown that the risk of contracting the coronavirus is substantially reduced for up to 10 months following the first infection, PTI reported.

The research looked at rates of Covid-19 infections among over 2,000 care home residents and staff in England, between October last year and February this year.

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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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VK Paul says Pfizer indicated delivery of vaccines by July

by Medically Speaking Team
written by Medically Speaking Team

This Central government is in discussion with Pfizer as the American Pharmaceutical company has indicated to provide its Covid-19 vaccine possibly in July, informed Dr VK Paul, Chair of the National Expert Group on Vaccine Administration (NEGVAC) for Covid-19.

During a press briefing, Dr Paul said, “We are engaged with Pfizer as they have indicated the availability of a certain volume of vaccine in coming months, possibly in July.”

He said, “They have requested indemnity against liability to all the nations, even the US. We are examining this request. We will take decision in the larger interest of people. It is under discussion but there is no decision as of now.”

Meanwhile, to ramp up the Covid-19 vaccination production domestically, Dr Paul said that the manufacturers – Bharat Biotech and Serum Institute of India – are putting in significant efforts to increase their vaccination production capacity.

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India expecting Moderna delivery next year, Pfizer offers 5 cr doses in 2021

by Medically Speaking Team
written by Medically Speaking Team

Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla, among other Indian firms, while another US giant Pfizer is ready to offer five crore shots in 2021 itself, but it wants significant regulatory relaxations, including indemnification, according to sources.

While Moderna has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021, there are limited prospects of Johnson & Johnson exporting its jabs from the US to other countries in the near future.

Two rounds of high-level meetings chaired by the Cabinet Secretary were held last week on the availability of vaccines in the global as well as domestic markets as it was felt that there is an urgent need to procure the jabs at a time the country is reeling under an unprecedented second wave of COVID-19 and a widening gap between supply and requirement.

Currently, the country is using two ‘made-in-India’ jabs — Covishield and COVAXIN — to inoculate its billion-plus population, and has administered 20 crore doses since launching the world’s largest vaccination drive in mid-January. A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.

In the high-level meeting officials from the Ministry of External Affairs (MEA), NITI Aayog, Department of Biotechnology (DBT), Ministry of Law and Ministry of Health and Family Welfare (MoH&FW) were present.

It was discussed that Moderna doesn’t have surplus vaccines to share in 2021 and that it plans to launch its single-dose vaccine for the Indian market only in 2022, for which, they are in discussion with Cipla and other Indian companies, a source said.

It is learnt that Cipla has already evinced interest in procuring five crore doses from Moderna for 2022, and has requested confirmation from the Central government in respect of stability in regulatory requirements/policy regime. The health ministry has also been asked to take an early decision on Cipla’s request regarding support required by them for procurement of Moderna vaccines.

In the case of Pfizer, the US pharma giant has indicated availability of five crore vaccine doses — one crore in July, one crore in August, two crore in September and one crore in October — for supply to India in 2021 and that it will deal only with Government of India and payment for vaccines will have to be made by the Centre to Pfizer India.

The Central government will make its own arrangement for further channelisation of procured vaccines in the domestic market.

According to another source, for the supply of vaccines to India, Pfizer has asked for indemnification from the Government of India and a document in this regard has been received from Pfizer Inc.

Further, Pfizer has also sought certain relaxations in the regulatory regime, including relaxation in the requirement of post-approval bridging trials and dispensing the requirement of testing their vaccines in the Central Drugs Laboratory (CDL).

Taking into consideration the track record of the company, similar arrangements done with other countries in the world and the current pandemic situation, an overall view may be taken to indemnify the company by the government, officials said but flagged that in case a view is taken to indemnify the company, similar demands may be made by other companies.

As per the information furnished by Pfizer, around 116 countries in the world, including the USA, have signed the indemnification document.

Further, considering that over 14.7 crore doses of Pfizer had been administered worldwide without any significant reports of adverse effects, a view needs to be taken to indemnify the company in order to supplement the availability of vaccines in India, officials discussed at one recent meeting.

It was suggested that a decision on the issue of Pfizer Inc may be taken at the earliest and that the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) may hold a meeting immediately on these issues.

At a press conference earlier this week, in response to a question on states being unable to procure vaccines directly from Moderna and Pfizer, Lav Agarwal, Joint Secretary, MoH&FW had said, “Whether it is Pfizer or Moderna, at the Centre-level, we have been coordinating with them.

“Also, the order book of both Pfizer and Moderna is full. So, it depends on their surplus that how much they can provide in India… they will come back to the Centre and we will help in facilitation to states.”

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Pfizer, Moderna, J&J pledge 1.3 billion doses of Covid-19 vaccines at Global Health Summit

by Medically Speaking Team
written by Medically Speaking Team

Pharmaceutical companies Pfizer, Moderna and Johnson & Johnson pledged at the Global Health Summit in Rome to provide 1.3 billion doses of Covid-19 vaccines on a non-profit basis to low and middle income countries in 2021.

The Global Health Summit, which was organised on Friday by Italy in its role as president of the G20 in partnership with the European Commission, emphasised the urgent need to scale up efforts, including through synergies between the public and private sectors, to enhance timely and equitable access to effective and affordable Covid-19 vaccines, therapeutics and diagnostics.

Pfizer, Moderna and Johnson & Johnson pledged the vaccines will be provided to low-income countries at production cost and middle income countries at low cost. This includes one billion doses from Pfizer, 200 million from Johnson & Johnson and 100 million from Moderna. Most of these doses will be delivered through the WHO-backed COVAX facility.

The European Union will also donate 100 million doses to low and middle income countries by the end of the year, said European Commision President Ursula Von der Leyen, who co-hosted the summit with Italian Prime Minister Mario Draghi.

“The pandemic has shown the importance of international cooperation to address the current and any future health crisis. In more general terms, we must look across borders and across disciplines if we are to meet the challenges of our times,” Italian ambassador Vincenzo de Luca said.

“These include not only the pandemic but also global inequalities and climate change,” he said, adding this was the spirit of the Rome Declaration adopted at the Global Health Summit.

The Rome Declaration sets out a series of mutual reinforcing principles and commitments that will guarantee improved preparedness, a coordinated response, resilience to and recovery from the Covid-19 pandemic and better preparation for future health emergencies.

Within the framework of the Global Health Summit, all participants announced additional pledges aimed at guaranteeing a forceful and coordinated response to the pandemic.

“So long as the virus continues to circulate freely worldwide, it can mutate and undermine even the most successful vaccination campaign. The free flow of raw materials and vaccines across borders is essential,” De Luca said.

Europe has so far exported about 200 million doses of vaccines to 90 countries. Italy has pledged a new donation of 15 million doses of vaccines to low-income countries before the end of 2021.

At the Global Health Summit, Italy also announced a pledge of an additional 300 million euros for equitable distribution of vaccines, and a separate pledge of 200 million euros for initiatives to foster climate and health security in low-income countries.

The participants of the Global Health Summit committed to promote and make tangible progress towards the principles of the Rome Declaration by the G20 Summit in Rome in October.

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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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Spanish study finds AstraZeneca vaccine followed by Pfizer dose is safe and effective

by Medically Speaking Team
written by Medically Speaking Team

The Combivacs study, run by Spain’s state-backed Carlos III Health Institute, found the presence of IgG antibodies in the bloodstream was between 30 and 40 times higher in people who got the follow-up Pfizer shot than in a control group who only received one AstraZeneca dose.

Meanwhile, the presence of neutralising antibodies rose sevenfold after a Pfizer dose, significantly more than the doubling effect observed after a second AstraZeneca shot.

Around 670 volunteers between the ages of 18-59 who had already received a first dose of AstraZeneca’s vaccine participated in the study, with some 450 given a Pfizer dose.

Just 1.7 per cent of the participants reported severe side effects, which were limited to headaches, muscle pain and general malaise, said Dr Magdalena Campins, one of the study’s leaders.

“These are not symptoms that can be considered serious,” she said.

In a U.K. “mix-and-match” study, first findings recently showed that people vaccinated with a shot of Pfizer’s vaccine followed by a dose of AstraZeneca’s, or vice versa, were more likely to report mild or moderate symptoms such as headaches or chills than if they received two of the same type. Data on immune responses are expected in the coming months.

Spain embarked on the study to determine how best to proceed after limiting AstraZeneca’s shot to people aged over 60 due to concerns about blood clotting in younger people.

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Biden boosting world vaccine sharing commitment to 80 million doses

by Medically Speaking Team
written by Medically Speaking Team

U.S. President Joe Biden said on Monday that the nation will share an additional 20 million doses of Covid-19 vaccines with the world in the coming six weeks as domestic demand for shots drops and global disparities in distribution have grown more evident.

The doses will come from existing production of Pfizer, Moderna or Johnson & Johnson vaccine stocks, marking the first time that US-controlled doses of vaccines authorized for use in the country will be shared overseas. It will boost the global vaccine sharing commitment form the US to 80 million.

“We know America will never be fully safe until the pandemic that’s raging globally is under control,” Biden said at the White House.

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