Tag: Pfizer vaccine

Israeli study finds Pfizer vaccine 85% effective after first shot

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The first dose of Pfizer Inc’s COVID-19 vaccine is 85 percent effective, a study of healthcare workers at an Israeli hospital has found, potentially fuelling a debate over the recommended two-dose schedule as governments try to stretch out supplies.

The Sheba Medical Center’s findings compare with overall efficacy of around 95 percent in a two-dose regimen 21 days apart for the shot developed with Germany’s BioNTech. The Sheba study, to be published in The Lancet medical journal, comes a day after Canadian researchers suggested that the second Pfizer dose be delayed given the high level of protection from the first shot in order to increase the number of people getting vaccinated.

Their research showed the efficacy of 92.6 percent after the first dose, based on an analysis of the documents submitted by the drugmaker from its late-stage human trials to the US Food and Drug Administration in December. The FDA said in December data from those trials showed that the vaccine began conferring some protection to recipients before they received the second shot, but more data would be needed to assess the potential of a single-dose shot.

Pfizer has said alternative dosing regimens of the vaccine have not been evaluated yet and that the decision resided with the health authorities. Sheba said among 7,214 hospital staff who received their first dose in January, there was an 85 percent reduction in symptomatic COVID-19 within 15 to 28 days. The overall reduction of infections, including asymptomatic cases detected by testing, was 75 percent.

Sheba epidemiologist Gili Regev-Yochay cautioned that the cohort studied at the hospital were ”mostly young and healthy”. Unlike with Pfizer’s clinical trial, ”we don’t have many (staff) here aged over 65,” she told reporters. But she also noted that the Sheba study took place during a surge in COVID-19 infections in Israel, which flooded hospitals with new cases.

Pfizer declined to comment on the data, saying in a statement it was doing its own analysis of ”the vaccine’s real-world effectiveness in several locations worldwide, including Israel.” It hopes to use Israeli data to look at the potential of the vaccine to protect against COVID-19 arising from emerging variants, the drugmaker said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Australia approves AstraZeneca vaccine for use

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Australia’s regulator on Tuesday approved the AstraZeneca vaccine as its second for use against COVID-19. Pfizer’s product will be available in Australia next week. It will be given in two doses three weeks apart, while AstraZeneca’s will be administered in two doses 12 weeks apart.

Prime Minister Scott Morrison said the Therapeutic Goods Administration, the regulator, found the AstraZeneca vaccine was safe and effective. Health Minister Greg Hunt said the AstraZeneca vaccine will prevent serious COVID-19 illness.

Morrison will be vaccinated with the Pfizer product and Hunt with AstraZeneca in a demonstration of confidence in both vaccines. Australia has contracted 53.8 million doses of the AstraZeneca vaccine, and 50 million of those will be manufactured in Australia.

The government has also secured 20 million Pfizer vaccines for a population of 26 million.

Click here: For the latest news and updates on COVID-19

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer vaccine can neutralise coronavirus variants first reported in UK, SA: Study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The COVID-19 vaccine co-developed by the American pharmaceutical giant Pfizer and the German biotechnology company BioNTech can neutralise variants of the novel coronavirus that were first reported in the UK and South Africa, a new study suggests. The research, published in the journal Nature Medicine, noted that the vaccine is effective against coronavirus variants carrying the N501Y and E484K mutations.

According to the scientists, including those from the University of Texas in the US, these variants have a substitution of the amino acid building blocks that make up the viral spike protein — the part of the virus which enables it to enter human cells. They said these mutations in the 501st and 484th positions of the protein’s amino acid molecule chain appeared in the UK and the South African variants, and could potentially increase the affinity of the viral spike for the receptor on the human cell through which the virus enters cells. In particular, they said the N501Y mutation may also expand the range of hosts the virus can infect to include mice.

In the current study, the scientists, Pei-Yong Shi and his colleagues engineered combinations of mutations found in these circulating variants and tested a panel of human sera from 20 participants.

They said the sera were obtained from their clinical trial of the Pfizer-BioNtech vaccine obtained two or four weeks after immunisation with two doses spaced three weeks apart. When they tested the serum against the coronavirus strains, the authors found evidence of neutralisation of the mutant viruses by the sera panel, with slight variation.

According to the scientists, neutralisation against the E484K mutation was slightly lower than that against the N501Y mutation. Commenting on the research, virologist Lawrence Young from the University of Warwick in the UK, said the findings confirm previous studies indicating that the Pfizer vaccine is very likely to be effective against the UK variant.

”It shows that the mutations found in the South African variant reduced the efficiency of virus neutralisation by 50 percent but only in six out of the 20 sera examined,” said Young, who was not related to the study. Jonathan Ball, Professor of Molecular Virology, University of Nottingham in the UK, also noted that the findings are promising.

”This is important work and provides reassurance that the antibody response generated by the Pfizer vaccine is able to neutralise coronavirus genetically engineered to carry some of the mutations seen in the variants of concern first identified in the UK and South Africa,” Ball, who was also unrelated to the study, said in a statement. ”However, we suspect that the effects of these mutations can be influenced by mutations occurring in other parts of the spike protein, so it will be important to validate these promising findings using viruses engineered to carry all of the mutations found in each variant,” he added.

Due to the ongoing evolution of the coronavirus, the study authors called for continuous monitoring of vaccine efficacy for emerging variants.

Click here: For the latest news and updates on COVID-19

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Norway vaccine deaths: Pfizer downplays safety concerns; says number of incidents not alarming

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Pharma major Pfizer has downplayed safety concerns following 29 deaths in Norway after the victims were administered its vaccine codenamed BNT162b2 – being developed along with Germany’s BioNTech. Citing Norwegian Medicines Agency (NOMA), the company said that the number of incidents so far was not alarming and was in line with expectations.

Initially, 23 deaths were reported — all from the age group of over 80 years. However, later additions lowered the age group, which was affected to 75. NOMA is investigating the deaths.

Pfizer said they are working with the Norwegian agency to gather all relevant information. “Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2. Our immediate thoughts are with the bereaved families,” a statement from Pfizer read.

“Norwegian authorities have prioritised the immunisation of residents in Nursing Homes, most of whom are very elderly with underlying medical conditions and some who are terminally ill. NOMA confirms the number of incidents so far is not alarming, and in line with expectations,” the statement added.

Pfizer said that all the deaths will be thoroughly evaluated to “determine if these incidents are related to the vaccine”.

The company further said that the Norwegian government is considering adjusting their instructions on who should be administered the vaccine, taking into account the patients’ health conditions.

Earlier, NOMA asserted that it was not alarmed by the incident. “It is quite clear that these vaccines have very little risk, with a small exception for the frailest patients,” Medical Director Steinar Madsen was quoted as saying by AP. After the assessment of the first few cases of death, the agency said that all of them were related to elderly people with serious basic disorders.

So far, more than 42,000 people in Norway have been administered the first dose of the vaccine. The country is focusing on people at high risk, including the elderly to get inoculated.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer/BioNTech vaccine appears effective against mutation in new coronavirus variants – study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

Pfizer Inc and BioNTech’s COVID-19 vaccine appeared to work against a key mutation in the highly transmissible new variants of the coronavirus discovered in the UK and South Africa, according to a laboratory study conducted by the U.S. drugmaker.

The not-yet peer-reviewed study by Pfizer and scientists from the University of Texas Medical Branch indicated the vaccine was effective in neutralizing virus with the so-called N501Y mutation of the spike protein.

The mutation could be responsible for greater transmissibility and there had been concern it could also make the virus escape antibody neutralization elicited by the vaccine, said Phil Dormitzer, one of Pfizer’s top viral vaccine scientists.

The study was conducted on blood taken from people who had been given the vaccine. Its findings are limited because it does not look at the full set of mutations found in either of the new variants of the rapidly spreading virus.

Dormitzer said it was encouraging that the vaccine appears effective against the mutation, as well as 15 other mutations the company has previously tested against.

“So we’ve now tested 16 different mutations, and none of them have really had any significant impact. That’s the good news,” he said. “That doesn’t mean that the 17th won’t.”

Dormitzer noted another mutation found in the South African variant, called the E484K mutation, is also concerning.

The researchers plan to run similar tests to see if the vaccine is effective against other mutations found in the UK and South African variants and hope to have more data within weeks.

Scientists have expressed concern that vaccines being rolled out may not be able to protect against the new variants, particularly the one that emerged in South Africa.

Simon Clarke, an associate professor in cellular microbiology at the University of Reading, said this week that while both variants had some new features in common, the one found in South Africa “has a number additional mutations” that included more extensive alterations to the spike protein.

The Pfizer/BioNTech vaccine and the one from Moderna Inc, which use synthetic messenger RNA technology, can be quickly tweaked to address new mutations of a virus if necessary. Scientists have suggested the changes could be made in as little as six weeks.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

States will start getting COVID-19 vaccine Monday, US says

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The nation’s first COVID-19 vaccine will begin arriving in states Monday morning, US officials said Saturday, after the government gave the final go-ahead to the shots needed to end an outbreak that has killed nearly 300,000 Americans.

Trucks will roll out Sunday morning as shipping companies UPS and FedEx begin delivering Pfizer’s vaccine to nearly 150 distribution centers across the states, said Army Gen. Gustave Perna of Operation Warp Speed, the Trump administration’s vaccine development program. An additional 425 sites will get shipments Tuesday, and the remaining 66 on Wednesday.

Initially, about 3 million doses were expected to be shipped nationwide. It was unclear exactly who would receive the first shots, though health care workers and nursing home residents were the priority. Perna said health authorities would decide.

A similar number of shots will be held back for those recipients’ second dose, which is needed for full protection from COVID-19.

The announcement Saturday kicks off a massive logistical operation involving the federal and state governments, private companies and health care workers to quickly distribute limited vaccine supplies throughout the US. It offers hope in a country grappling with surging COVID-19 infections and deaths, which are overwhelming hospitals and raising fears that things will only get worse as people gather over the holidays.

Perna compared the vaccine distribution effort to D-Day, the US-led military offensive that turned the tide in World War II.

“D-Day was the beginning of the end and that’s where we are today,” Perna said a news conference. But he added that it would take months of work and “diligence, courage and strength to eventually achieve victory.”

MaineHealth, a network of 12 hospitals based in Portland, plans to provide an expected first delivery of nearly 2,000 vaccines to doctors, nurses and others facing risk as they treat COVID-19 patients, said Dr. Dora Mills, chief health improvement officer.

“It’s almost hard for me to talk about without tearing up,” Mills said Saturday. “This vaccine gives us some glimmer of light at the end of the tunnel.”

The first shipments will leave Pfizer’s manufacturing plant in Kalamazoo, Michigan, by truck and then be flown to regional hubs around the country. Medical distributor McKesson and pharmacy chains, including CVS and Rite-Aid, also are involved in the initial rollout and vaccinations at nursing homes and assisted living centers.

In a key distribution challenge, the vaccine, co-developed with BioNTech, must be stored and shipped at ultra-low temperatures—about 94 degrees below zero. Pfizer has developed shipping containers that use dry ice, and GPS-enabled sensors will allow the company to track each shipment and ensure it stays cold.

Distribution sites are mainly large hospitals and other facilities able to meet those ultra-cold storage requirements. Within three weeks, vaccines should be delivered to all vaccination sites identified by states, such as local pharmacies, Perna said.

The vaccine was timed to arrive Monday so health workers could receive the shots and begin giving them, Perna said.

Workers at Mount Sinai Hospital System in New York did a dry run this week to prepare for their shipment. In a clean room, pharmacists practiced making separate doses of a training vaccine and ensuring the freezer was kept at temperatures colder than in Antarctica.

“Not a lot of people have vaccinated for a large pandemic like this,” said Susan Mashni, vice president of pharmacy at Mount Sinai. “So we want to make certain that we get it right. There’s a lot of different moving pieces and parts.”

At a meeting where an expert panel advising the Centers for Disease Control and Prevention on vaccines unanimously endorsed the Pfizer shot, some said local health officials were struggling to ensure the vaccine is distributed fairly and to those most in need and to ease people’s concerns about getting the shot.

But “the funding necessary for state and local health departments to carry out this program has been put in the deep freeze,” said Dr. Jeffrey Duchin, a Seattle physician representing the National Association of County and City Health Officials.

The Food and Drug Administration authorized emergency use of the vaccine late Friday. It capped an unprecedented global race to speed vaccines through testing and review, chopping years off the normal development process.

The FDA found the vaccine highly protective with no major safety issues. U.S. regulators worked for months to emphasize the rigor and independence of their review, but President Donald Trump’s administration pressured the agency until the final announcement. A top White House official even threatened to remove FDA chief Stephen Hahn if a ruling didn’t come before Saturday.

Concerns that a shot was rushed out could undermine vaccination efforts in a country with deeply ingrained skepticism about vaccines.

“Science and data guided the FDA’s decision,” Hahn said Saturday. “We worked quickly because of the urgency of this pandemic, not because of any other external pressure.”

While the vaccine was determined to be safe, regulators in the U.K. are investigating several severe allergic reactions. The FDA’s instructions tell providers not give it to those with a known history of severe allergic reactions to any of its ingredients.

The FDA’s vaccine director, Dr. Peter Marks, said the agency will carefully track any reports of allergic reactions in the US.

Next week, the FDA will review a vaccine from Moderna and the National Institutes of Health that appears about as protective as Pfizer’s shot. On Friday, the Trump administration said it had purchased 100 million more doses of that vaccine on top of 100 million it previously ordered.

The announcement came after revelations that the White House opted not to lock in an additional 100 million doses of Pfizer’s vaccine for delivery in the second quarter of 2021. The Trump administration contends the current orders plus those in the pipeline will be enough to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

India invites UK PM Boris Johnson for Republic Day, says report

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

India has invited UK PM Boris Johnson for the Republic Day celebrations, according to a report by Hindustan Times. Prime Minister Modi invited his counterpart over a call on November 27.

When approached, the UK High Commission Spokesperson told CNBC-TV18 that this could not be confirmed currently.

It is also learnt that Johnson told Modi that 2021 should be a year for strengthening India-UK relationship.

We can’t confirm one way or other, PM Boris Johnson keen to visit India as soon as possible: British High Commission Spokesperson to ANI on reports of India’s invitation to UK PM for Republic Day

— ANI (@ANI) December 2, 2020

Meanwhile, the UK authorities have allowed Pfizer vaccine for emergency use on Wednesday. British Prime Minister Boris Johnson said that any COVID-19 vaccines should be voluntary and that they would not be made obligatory.

Asked if vaccines should be voluntary, Johnson said: “I strongly urge people to take up the vaccine but it is no part of our culture or our ambition in this country to make vaccines mandatory. That is not how we do things.”

However, this may be of little cheer to India. Kiran Mazumdar Shaw, Executive Chairperson of Biocon in an earlier interview with CNBC-TV18 said, “The Pfizer vaccine is unlikely to make its way to India,” Shaw said, “…because the ultra-cold chain that it requires of minus 70 degrees is something that we may not be in a position to handle. It is not something that will be conducive for India,” she added.

However just today, in a bid to ensure the preparedness of cold chain system for safe storage of COVID-19 vaccine once it is introduced, the union health ministry has yet again reached out to states and union territories to initiate a strategy for the same.

According to the communication made by the Centre, sources told CNBC-TV18, “Union health ministry has asked states to strategise on about seven major parameters, including putting in place alternate vaccine delivery system for seamless supply.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

EU drug regulator could rule on COVID-19 vaccines by year end – report

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

The European Medicines Agency (EMA) could produce a scientific opinion on COVID-19 vaccines seeking regulatory approval by the end of the year in a best case scenario, the regulator’s new chief was quoted as saying on Tuesday.

British drugmaker AstraZeneca followed rivals Pfizer and Moderna on Monday in publishing successful pivotal trial data for its COVID-19 vaccine, giving the world’s fight against the pandemic a third new weapon.

“Assuming everything is positive – and we have to look at the data to be sure – but best case, we could have a scientific opinion by the end of the year,” EMA Executive Director Emer Cooke told the Irish Independent newspaper in an interview.

“These have been developed very quickly, which is very promising from a scientific perspective, but it means there is a lot of attention on the results and we have to make sure we evaluate those as efficiently as we can without compromising our usual scientific standards.”

The newspaper also quoted Cooke as saying that the EMA’s aim was to reach a positive recommendation on a similar timeline to the U.S. Food and Drug Administration (FDA), which is expected to have a verdict in mid-December on Pfizer’s proposed vaccine.

Cooke added that the agency may recommend the use of vaccines based on results in different groups, such as the elderly or people with underlying health conditions.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer COVID vaccine: Many unanswered questions, feels Gagandeep Kang

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

Listen to the Article (6 Minutes)

American drug major Pfizer has claimed that the first interim analysis of the COVID vaccine, which it is developing in collaboration with BioNTech has shown over 90 percent effectiveness. Pfizer says that it expects to seek broad emergency use authorisation from the US FDA in the coming weeks.

Here’s a quick caveat, Pfizer’s claim is yet to be peer-reviewed.

To understand more about the Pfizer vaccine and whether India is in a position to distribute the vaccine in India if the approval comes through, Dr. Gagandeep Kang, Professor at Christian Medical College, spoke to CNBC-TV18.

Kang said, “This is actually a pretty phenomenal result, I don’t think any of us were expecting 90 percent efficacy so this is very very good. But if we look at vaccines, this is an interim analysis we need to wait until the entire trail is over, that is likely to happen in a few months, given that there are so many cases in many of the places where the phase III trials are being done.”

She further added, “It is possible the efficacy may drop a little bit but by the time trial is done but I don’t expect it to drop by a lot because the trial will be completed quickly. But we need to know how long protection will last and will it work in children so in summary, the news is good, but there are a lot of unanswered questions.”

Talking about infrastructure for vaccine Kang added, “The vaccine that does the greatest good for the greatest number is the way to go about it. Here we have a vaccine that looks really promising, but we don’t have the cold chain infrastructure for ultra-cold storage.”

Watch this video for more.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow