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Pfizer sets up global drug development centre in India

It will also develop and support products in global markets and Pfizer’s manufacturing centres worldwide…reports Asian Lite News

Global pharma giant Pfizer, which developed the mRNA-based vaccine against Covid, on Wednesday announced setting up a global drug development centre to boost critical research and development (R&D) capabilities in India.

The 61,000 sq ft research and technology centre will be set up at the Indian Institutes of Technology (IIT) Madras Research Park in Chennai, the company said. Pfizer said it has invested more than Rs 150 crore in it.

While this centre will be a part of a network of 12 global centres set up worldwide, it is the first and only one at present being set up by Pfizer in Asia.

“We are confident that this research centre would be aligned with our larger national objective to improve the availability, affordability and access to drugs throughout the world from India by building on the convergence with digital solutions available here, and leveraging academic collaborations,” said S. Aparna, Secretary, Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers, during the launch.

The centre will include the development of both, active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) of differentiated products such as complex/value-added formulations, controlled-release dosage forms, device-combination products, lyophilised injections, powder-fill products, and ready-to-use formulations.

It will also develop and support products in global markets and Pfizer’s manufacturing centres worldwide.

“Pfizer’s drug development centre in the IIT Madras Research Park is a positive opportunity to establish truly one of the most advanced laboratories that Pfizer is setting up for R&D in the aforementioned disciplines anywhere in the world, in Chennai and an opportunity to showcase the potential of R&D in the country,” said S. Sridhar, Country Manager, Pfizer India, in a statement.

ALSO READ-Pfizer set to supply Paxlovid Covid pills to Africa

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Pfizer set to supply Paxlovid Covid pills to Africa

US drugmaker Pfizer is set to supply Africa’s top health body with its Covid antiviral pill Paxlovid…reports Asian Lite News

Paperwork for the deal between the Africa Centres for Disease Control (CDC) and Pfizer is now in the hands of the African Union’s legal office – after which a formal announcement will be made, Africa CDC director John Nkengasong was quoted as saying by the BBC.

Nkengasong urged health ministries to adopt robust measures spanning vaccines and testing. He added that the Africa CDCA is also seeking Merck’s molnupiravir pill.

This comes days after Moderna signed a deal with Kenya to build its first mRNA facility. Johnson & Johnson has also inked a pact with South African drugmaker Aspen to sell, package and distribute its Covid shots.

In February, researchers at the World Health Organisation-backed Africa’s first Covid mRNA vaccine technology-transfer hub made microlitres of the vaccine based on Moderna’s Covid shot.

The aim was to scale up vaccine production to address those massive shortfalls in the developing world. So far, roughly 12 per cent of people in Africa are fully vaccinated, well below the World Health Organization’s 70 per cent vaccination threshold.

Expressing concern about countries where vaccination rates were still very low, Nkengasong said African countries should be using a combination of public health measures, vaccines, and testing to overcome the Covid this year, Aljazeera reported.

ALSO READ: Africa’s Covid-19 cases pass 11.26 mn

“These molecules have a very unique role to play in a campaign to fight against this terrible pandemic,” he was quoted as saying, citing the Pfizer pill.

Studies by the pharma giant have shown that Paxlovid is effective against all Covid strains, particularly to the highly contagious and vaccine evading Omicron variant. CEO Albert Bourla estimates that the pills can avert 1,200 deaths and 6,000 hospitalisations for every 100,000 Covid patients who take the pills.

Both Paxlovid and molnupiravir have shown to reduce the chances of hospitalisation or death from Covid-19 in high-risk patients by 89 per cent and 30 per cent respectively. The pills should be taken early, within 3-5 days of getting Covid, and require several pills, multiple times a day for five days.

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Pfizer initially rejected BioNTech’s offer to develop vaccine

It is because Dormitzer had been involved with discussions about whether to create vaccines for MERS and SARS, only to see the pathogens quickly contained…reports Asian Lite News.

US drug maker Pfizer wrongly assumed that the coronavirus outbreak would be quickly contained and thus declined the offer made by BioNTech to develop a vaccine against the infectious disease that has so far claimed more than 4 million lives globally.

Germany-based BioNTech, now capitalised at US$84 billion, helmed by Turkish couple Dr Ugur Sahin and his wife Dr Ozlem Tureci, were given a “no” by the pharmaceutical giant as the virus was starting to sweep the globe in January 2020, the Telegraph reported.

“Guys, this is not going to work, they were told by Dr Phil Dormitzer, Pfizer’s Vice President and Chief Scientific Officer for vaccines. Dormitzer also considered it to be too experimental,” the report said.

“My working assumption was that it (Covid-19) would be controlled” like the SARS and MERS outbreaks, Dormitzer later confirmed.

It is because Dormitzer had been involved with discussions about whether to create vaccines for MERS and SARS, only to see the pathogens quickly contained.

However, it was only a “matter of time” before Pfizer changed its mind and a deal was announced between the two companies a month later.

So far, about 1.4 billion doses of Pfizer and BioNTech two-dose revolutionary Covid jab, developed based on mRNA technology, has been shipped to more than 120 countries.

BioNTech founders revealed the story of initial rejection by Pfizer in a new book titled The Vaccine, written by journalist Joe Miller, to be released this week, the report said.

It also accounts how the couple, who emigrated to Germany from Turkey as small children and met on a cancer ward as young doctors, built not one billion-dollar biotech company but two. And how they gambled everything to pivot BioNTech to focus exclusively on a Covid vaccine in early 2020, it added.

ALSO READ-UK signs deal with Pfizer/BioNTech for 35mn vaccines

READ MORE-US govt may authorise Pfizer shot for kids aged 5 to 11 in Oct

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Pfizer, Moderna raise Covid-19 vaccine prices in EU


The supply contracts are being renewed as Europe is anxious to secure supplies for potential booster shots in the face of the spread of the highly infectious Delta variant…reports Asian Lite News.

US drug makers Pfizer and Moderna have increased the prices of their mRNA-based vaccines against Covid-19 for the European market, the media reported.

According to the new contracts, a Pfizer shot will now cost 19.50 euros against 15.50 euros previously, while a Moderna jab has been priced at 21.49 euros a dose, from about 19 euros in the first procurement deal, The Financial Times reported.

The supply contracts are being renewed as Europe is anxious to secure supplies for potential booster shots in the face of the spread of the highly infectious Delta variant.

Further, the terms of the deals, struck this year for a total of up to 2.1 billion shots until 2023, were renegotiated after phase 3 trial data showed the two companies’ mRNA vaccines had higher efficacy rates than shots developed by Oxford/AstraZeneca and Johnson & Johnson, the report said.

The companies had capitalised on their market power and deployed the “usual pharma rhetoric… Vaccines work so they increased the ‘value’,” the report quoted an official close to the negotiations official.

Riding on the success of its Covid vaccine, Pfizer, last week, raised its annual vaccine revenue to $33.5 billion in 2021, up from the previously projected $26 billion.

Prices for higher-income countries were “comparable”, with middle-income countries charged about half and lower-income countries paying cost, Chief executive Albert Bourla was quoted as saying.

Moderna is expected to announce the second quarter financial results this week. According to forecasts compiled by Airfinity, a life sciences consultancy, the sales of Pfizer’s Covid jab will hit 47.1 billion euros with Moderna’s reaching 25.2 billion euros, the FT reported.

On the other hand, sales of Oxford/AstraZeneca’s Covid jab — the largest vaccine supplied to low-income countries — is expected to rise to 12.6 billion euros in 2022, it added.

ALSO READ-‘Pfizer, AZ vax antibodies may drop 50% in 3 months’

READ MORE-Pfizer recommends 3rd Covid shot for Delta variant

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Pfizer recommends 3rd Covid shot for Delta variant

Pfizer anticipates applying for emergency use authorization for a third dose of its vaccine as soon as next month…reports Asian Lite News

 American biopharmaceutical company Pfizer has said a third dose of its Covid-19 vaccine can “strongly” boost protection against the Delta variant.

Antibody levels against the Delta variant in people aged 18 to 55 who receive a third dose of the Pfizer/BioNTech vaccine are greater than five-fold than following a second dose, according to data posted at the company’s teleconference, Xinhua reported.

Among people aged 65 to 85, the Pfizer data suggest that antibody levels against the Delta variant after receiving a third dose are greater than 11-fold than following a second dose.

Pfizer anticipates applying for emergency use authorization for a third dose of its vaccine as soon as next month, Mikael Dolsten, who leads worldwide research, development and medical for Pfizer, was quoted by CNN as saying at the teleconference.

ALSO READ: Nepal confirms new mutant of Delta variant of Covid-19

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‘Pfizer, AZ vax antibodies may drop 50% in 3 months’

The researchers highlighted that although the clinical implications of waning antibody levels are not yet clear, some decline was expected and current research shows that vaccines remain effective against severe disease…reports Asian Lite News.

Total antibody levels produced by both Pfizer and AstraZeneca appear to start declining from as early as six weeks after two vaccine doses and can reduce by more than 50 per cent over 10 weeks, according to a new study stressing the need for booster doses.

The study, led by researchers of the University College London, showed that the waning effect of the vaccine doses were consistent across all groups of people regardless of age, chronic illnesses or sex.

Published as a research letter in The Lancet, the study included data from over 600 people and showed antibody levels are substantially higher following two doses of the Pfizer vaccine than after two doses of the AstraZeneca jab.

AstraZeneca vaccine

They are also much higher in those with prior SARS-CoV-2 infection.

The researchers highlighted that although the clinical implications of waning antibody levels are not yet clear, some decline was expected and current research shows that vaccines remain effective against severe disease.

For Pfizer, antibody levels reduced from a median of 7506 U/mL at 21-41 days, to 3320 U/mL at 70 or more days. For AstraZeneca, antibody levels reduced from a median of 1201 U/mL at 0-20 days to 190 U/mL (67-644) at 70 or more days.

“The levels of antibody following both doses of either the AstraZeneca or Pfizer vaccine were initially very high, which is likely to be an important part of why they are so protective against severe Covid-19,” said Maddie Shrotri from the UCL Institute of Health Informatics.

“However, we found these levels dropped substantially over the course of two to three months. If they carry on dropping at this rate, we are concerned that the protective effects of the vaccines may also begin to wear off, particularly against new variants; but we cannot yet predict how soon that might happen,” she added.

The findings support recommendations from the UK Joint Committee on Vaccination and Immunization (JCVI) that adults who are clinically vulnerable, those aged 70 years or over, and all residents of care homes for older adults should be prioritised for booster doses.

“In addition, those who were vaccinated with the AstraZeneca vaccine, including most care home residents, are likely to have much lower antibody levels than those vaccinated with the Pfizer vaccine, so this may also need to be considered when deciding who should be prioritised when boosters are rolled out,” said Professor Rob Aldridge from the UCL Institute of Health Informatics.

However, the study included only a small sample size and different people will have different levels of immunity depending on the virus neutralizing ability of their antibodies as well as their T-cell responses.

Thus, additional research is important to establish if there is an antibody level threshold needed for protection against severe disease, the researchers noted.

ALSO READ-‘Pfizer, AZ jabs highly effective against Delta variant’

READ MORE-Single dose of Pfizer, AZ offers 60% protection

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Single dose of Pfizer, AZ offers 60% protection

The team analysed 10,412 care home residents aged 65 years and older from 310 facilities, with a median age of 86 years. Of these 1,155 residents had evidence of previous SARS-CoV-2 infection…reports Asian Lite News.

A single dose of either the Pfizer or AstraZeneca Covid-19 vaccine offers around 60 per cent protection against infection from SARS-CoV-2, the virus causing Covid-19, in adults aged 65 years and above, according to a new study published in the The Lancet Infectious.

The study, led by researchers from the University College London, in the UK showed that the protective effect of a single dose of vaccination is evident from four weeks to at least seven weeks after vaccination, which provides some evidence to support extension of the interval between doses beyond three weeks, in line with UK policy.

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“However, even beyond four weeks, a single vaccine dose does not eliminate infection risk, highlighting the continued importance of non-pharmaceutical measures to control transmission within long-term care facilities,” said Madhumita Shrotri and Laura Shallcross, from the UCL Institute of Health Informatics.

The study will be critical to inform policy decisions regarding revaccination schedules in this vulnerable population and the disease control measures needed in the short, medium, and long term to protect long-term care facilities from future waves of SARS-CoV-2 infection, the team said.

The team analysed 10,412 care home residents aged 65 years and older from 310 facilities, with a median age of 86 years. Of these 1,155 residents had evidence of previous SARS-CoV-2 infection.

A total of 9,160 (88 per cent) residents received at least one vaccine dose during the study period, of whom 6,138 (67 per cent) received AstraZeneca (ChAdOx1) and 3,022 (33 per cent) received Pfizer (BNT162b2).

Between December 8, 2020 and March 15, 2021, there were 36,352 PCR tests carried out, with 1,335 PCR-positive infections detected (713 in unvaccinated residents and 612 in vaccinated residents).

The risk of infection was 56 per cent lower in vaccinated residents after 28 to 34 days, days, and 62 per cent lower at 35-48 days. Similar effect sizes at 35-48 days were seen for the AstraZeneca vaccine (68 per cent reduced risk of infection) and the Pfizer vaccine (65 per cent reduced risk).

The study will be presented at the 2021 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held from July 9-12.

ALSO READ-UK Begins Talks To Join Trans-Pacific Trade Bloc

READ MORE-MEA says overseas vaccine supply will depend on availability

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‘Pfizer, AZ jabs highly effective against Delta variant’

These are comparable with vaccine effectiveness against hospitalisation from the Alpha (B117) variant: 96 per cent after two doses with Pfizer vaccine and 92 per cent after two doses from AstraZeneca vaccines…reports Asian Lite News.

Two doses of Pfizer and AstraZeneca’s Covid-19 vaccines are highly effective against hospitalisation from the Delta (B16172) variant, according to new analysis from Public Health England (PHE).

The analysis suggests that the Pfizer-BioNTech vaccine is 96 per cent effective against hospitalisation after two doses, while the Oxford-AstraZeneca vaccine is 92 per cent effective against hospitalisation after two doses.

These are comparable with vaccine effectiveness against hospitalisation from the Alpha (B117) variant: 96 per cent after two doses with Pfizer vaccine and 92 per cent after two doses from AstraZeneca vaccines.

The new analysis included 14,019 cases of the Delta variant, 166 of whom were hospitalised between 12 April and 4 June, looking at emergency hospital admissions in England. The results have been posted as a preprint. Preprints are yet to be peer-reviewed.

“This evidence of the effectiveness of two doses against variants shows just how crucial it is to get your second jab. If you have had your first dose but haven’t booked your second yet — please do so. It will help save lives and boost us on the road to recovery,” said Health and Social Care Secretary Matt Hancock, in a statement.

“These hugely important findings confirm that the vaccines offer significant protection against hospitalisation from the Delta variant. The vaccines are the most important tool we have against Covid-19. Thousands of lives have already been saved because of them. It is absolutely vital to get both doses as soon as they are offered to you, to gain maximum protection against all existing and emerging variants,” added Dr Mary Ramsay, Head of Immunisation at PHE.

A study by PHE in May showed that three weeks after the first dose of both Pfizer and AstraZeneca’s coronavirus vaccine provided only 33 per cent protection against the Delta variant, while it offered 50 per cent effectiveness against the Alpha variant.

The B16172 variant was first discovered in India and is one of three related strains. It was declared as a variant of global concern last month by the World Health Organization (WHO). It is 60 per cent more transmissible than the Alpha strain identified in the UK.

ALSO READ-‘Delta Plus ‘variant of interest’ for now’

READ MORE-‘Delta’ Variant 40% More Contagious

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‘Pfizer-BioNTech vax very effective against UK, SA variants’

Among people 85 or older, the vaccine was more than 94 percent effective at preventing infection, hospitalization, and death…reports Asian Lite News.

The Pfizer-BioNTech Coronavirus vaccine is highly effective against severe pneumonia and death caused by both UK-, South Africa-variants, results of twin studies have shown.

The studies, based on the real-world use of the vaccine in Qatar and Israel, suggested that the vaccine can prevent the worst outcomes caused by B117, the variant first identified in the UK, and B1351, first identified in South Africa, in young and old.

The first study, published in The Lancet, showed that two doses of the Pfizer-BioNTech Covid vaccine are highly effective against Covid-19 for all people over the age of 16 years, providing 95.3 percent protection against infection and 96.7 percent protection against death seven days after the second dose.

Among people 85 or older, the vaccine was more than 94 percent effective at preventing infection, hospitalization, and death. The team from the Israel Ministry of Health used national pandemic surveillance data between January 24 and April 3. There were 232,268 confirmed Covid-19 infections in the country and the most prevalent strain was B117. It accounted for 94.5 percent of specimens tested.

AstraZeneca vaccine

The second study, appearing in the New England Journal of Medicine, is based on information about more than 200,000 people from Qatar’s national Covid-19 databases between February 1 and March 31, the New York Times reported.

In multiple analyses, the researchers found that the vaccine was 87 to 89.5 per cent effective at preventing infection with B117 among people who were at least two weeks past their second shot. It was 72.1 to 75 per cent effective at preventing infection with B1351 among those who had reached the two-week point, the report said.

The vaccine was highly effective at protecting against the worst outcomes. Overall, it was 97.4 percent effective at preventing severe, critical or fatal disease from any form of the coronavirus, and 100 per cent effective at preventing severe, critical or fatal disease caused by B117 or B1351.

“This is really good news. At this point in time, we can confidently say that we can use this vaccine, even in the presence of circulating variants of concern,” Annelies Wilder-Smith, an infectious disease researcher at the London School of Hygiene and Tropical Medicine, was quoted as saying on Thursday.

Also Read-Serum Institute to start vaccine production in London

Read More-US backs vaccine patent waiver plan proposed by India

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‘Moderna more troublesome than Pfizer’

The study, published in the journal JAMA, analysed reports collected via a Centers for Disease Control and Prevention (CDC) programme called v-safe that tracks side effects in vaccine recipients….reports Asian Lite News

In a first, a new study has pointed out that those taking the Moderna vaccine have reported more side effects than people who get the Pfizer/BioNTech jabs.

The study, published in the journal JAMA, analysed reports collected via a Centers for Disease Control and Prevention (CDC) programme called v-safe that tracks side effects in vaccine recipients.

A total of 3,643,918 people were enrolled in v-safe and completed at least one health survey within seven days following their first vaccine dose before February 21, and 1,920,872 v-safe participants reported receiving a second vaccine dose and completed at least one daily health survey within seven days following the second dose.

Nearly 70 per cent of those said they had some kind of injection site reaction, like pain or swelling, and half had generalised reaction like fatigue or chills.

“A greater percentage of participants who received the Moderna vaccine, compared with the Pfizer-BioNTech vaccine, reported reactogenicity; this pattern was more pronounced after the second dose,” the researchers noted.

Also read:CDC reveals Pfizer, Moderna jabs effective in real world

Reactogenicity refers to a subset of reactions that occur soon after vaccination.

People who got a Moderna shot were more likely to have a side effect — 73 per cent had an injection site reaction, compared with 65 per cent of people who had a Pfizer/BioNTech dose.

Nearly 51 per cent of Moderna recipients had full-body symptoms, compared with 48 per cent of people who got the Pfizer/BioNTech shot.

The gap widened after the second dose.

Almost 82 per cent of people getting their second Moderna shot had injection site pain versus just under 69 per cent of people with Pfizer/BioNTech, reports The Verge.

“Overall, 74 per cent of people said they had general reactions after their Moderna shot, compared with 64 per cent of people getting Pfizer/BioNTech,” the report said on Tuesday.

Zulema Riquelme, a 46-year-old nursing technician, receives a shot of the COVID-19 vaccine at the Metropolitan Hospital in Santiago, Chile

People over 65 were also less likely to have side effects than people under 65, regardless of which vaccine they received.

“Data from millions of v-safe participants indicate that injection site pain is common after both the first and second doses of either mRNA-based vaccine,” the study noted.

Systemic reactions, including fatigue, headache, myalgia, chills, fever, and joint pain, occurred in participants after the first dose, although they were more frequently reported after the second dose among both Pfizer-BioNTech and Moderna vaccine recipients.

Also read:CDC reveals Pfizer, Moderna jabs effective in real world