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Pfizer seeks quicker nod for vaccine, donates $70 million worth of drugs

Pfizer

is in discussions with the Indian government seeking an “expedited approval pathway” for its Covid-19 vaccine, chief executive Albert Bourla wrote on LinkedIn on Monday, announcing the US drug maker’s donation of medicines worth more than $70 million (₹517 crore) to the country.

Bourla said people at Pfizer distribution centres in the US, Europe and Asia were rushing shipments of medicines that the Indian government had identified as part of its Covid-19 treatment protocol, amid the surge in coronavirus cases in the country.

These include steroid medications to reduce inflammation, anticoagulants to help prevent blood clotting and antibiotics that treat secondary bacterial infections.

“This effort has the potential to impact the lives of hundreds of thousands of patients across India over the next 90 days,” he said. India is battling a massive second Covid-19 wave with new cases breaching 4 lakh on Friday. Daily fatalities have been more than 3,000 in recent days.

Pfizer said it was donating the medicines to help make sure that every Covid-19 patient in the country got access free of charge to its medicines they needed.

“These medicines, valued at more than $70 million, will be made available immediately, and we will work closely with the government and our NGO partners to get them to where they are needed most,” Bourla added. “We are committed to being a partner in India’s fight against this disease and are quickly working to mobilise the largest humanitarian relief effort in our company’s history,” he said.

“Unfortunately, our vaccine is not registered in India although our application was submitted months ago. We are discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country,” Bourla said.

The Indian government had last month allowed emergency use approval for imported vaccines which have been granted similar approvals by the regulators in the US, UK, Europe and Japan.

( Originally published on May 03, 2021 )

In Video: Pfizer in talks with Indian govt to allow use of its Covid vaccine

Some firms target T cell jabs in fight against Covid variants

Getting Covid vaccines into the arms of the world’s population is an international priority — but will today’s jabs stay effective against virus variants that are spreading across the globe?

It is one of the big questions about the pandemic, with

Pfizer

chief Albert Bourla recently acknowledging that it is likely that a booster will be needed to help extend the protection conferred by its vaccine and ward off new variants.

A recent study presented a mixed picture.

It found that the antibody response of current vaccines could fail against variants. However, a second immune response in the form of killer T cells — which attack already infected cells and not the virus itself — remained largely intact.

Several startups are working on developing shots centred on T cells in hopes of producing a jab that would not only provide protection against new virus strains already on the loose, but also variants that don’t yet exist.

Alexis Peyroles heads up French biotech firm OSE Immunotherapeutics, which is developing a vaccine that targets T cells that has just begun clinical trials.

“It could offer several years of protection,” he told AFP.

Another French firm, Lyon-based Osivax, is also working on a T cell shot, promising a “universal” vaccine that would be effective against any potential variant.

The government of France, which has yet to develop its own vaccine, is supporting the effort with millions in funding.

Such projects are far from widespread. Among the 400 vaccines under development counted by the World Health Organization only a few are aimed at universal use.

The most advanced shot of its kind is the ImmunityBio vaccine under development in the United States. Very preliminary results released last month were mostly encouraging.

No lab foresees a final product before next year and many scientists are skeptical about the usefulness of trying to develop a shot to protect against a virus strain that doesn’t yet exist.

“Mass vaccination itself is a form of evolutionary ‘selection’ pressure,” British virologist Julian Tang told AFP, “and this pressure may push the virus to evolve to escape any vaccine protection — so it can be a double-edged sword.”

Other questions involve the extent to which the body will be able to fight the virus with a T cell-based response.

T cells and antibodies work together to form an immune response in the body.

French virologist Yves Gaudin pointed out that if an antibody response fails, “T cells don’t serve much purpose”.

He said he is “doubtful about the effectiveness of such a vaccine,” emphasising that an ideal vaccine would be effective in both areas.

In Europe and the United States the plan for T cell jabs, should they see the light of day, would be to give them to people who had already received the current antibody vaccines.

Peyroles confirmed that OSE’s vaccine, should it prove effective in trials, is indeed meant as a way to strengthen current inoculations.

“You would complement and broaden the response created by the first vaccines in terms of scope and time.”

He added that T cell vaccines could offer protection to people who have difficulties developing antibodies due to other ailments such as diabetes or cancer.

Pfizer-BioNTech pledge 2 bn doses to less wealthy nations

American pharmaceutical company

Pfizer

and German company BioNTech pledged on Friday to deliver 2 billion doses of their Covid-19 vaccine to middle-and low-income countries over the next 18 months, amid international calls for more vaccine solidarity. The companies, which together developed the first vaccine to be authorised for use in the US and Europe, made the announcement at a global health summit in Rome co-hosted by the European Union’s executive arm and Italy.

Pfizer CEO Albert Bourla said that they expect to provide a billion of the doses this year and another billion in 2022. It was unclear whether the deliveries would take place through the UN-backed COVAX programme, which aims to ensure equitable access to Covid-19 shots for low-and middle-income countries, or if countries would get the doses at a reduced price.

Bourla said his company last year adopted a three-tiered pricing policy guaranteeing that low-income countries get the shots at cost and to have middle-income nations pay about half the price wealthier nations are charged.