Tag Archives: pfizer

EU export restrictions on COVID shots would be ‘lose-lose’ situation: Pfizer executive

By John Miller

ZURICH (Reuters) – European Union export restrictions on COVID-19 vaccines would result in a ‘lose-lose’ situation for everyone, including EU members, a Pfizer executive said, a day after the bloc tightened oversight of shot deliveries beyond its borders.

The EU’s action would give it greater scope to block shipments to countries with higher inoculation rates such as Britain, or which are not sharing doses that they produce.

The specter of export restrictions has many concerned, given the global nature of vaccine production, in which shots have hundreds of ingredients sourced in dozens of countries. New roadblocks for shots or raw materials could disrupt pandemic-fighting efforts as the world struggles to contain a third wave of infections, companies fear.

“We have observed these recent developments with concern,” Sabine Bruckner, Swiss country manager for Pfizer, said at a Swiss government press conference on Thursday.

“Our executive leadership has been in direct contact with the European Union. Our position has been laid out, we are very critical, we can’t support it at all,” she added.

“Should it really come to export restrictions, that would be a ‘lose-lose’ situation for everyone, also for the members of the European Union.”

The new rules set out by the European Commission, which oversees EU trade policy, expand existing measures aimed at ensuring planned exports by drugmakers do not threaten the bloc’s supply.

They add 17 previously exempt countries including Israel, Norway and Switzerland to the list of countries for which exports of EU-produced vaccines require licenses. Switzerland, for instance, gets its Pfizer COVID-19 shots from a plant in Belgium.

Pfizer’s Bruckner made the comments after a Swiss vaccine summit in which Health Minister Alain Berset predicted his country would receive 10.5 million vaccines from suppliers including Pfizer and Moderna by July, enough to vaccinate everybody in Switzerland who wants a shot, he said.

(Reporting by John Miller in Zurich and Philip Blenkinsop in Brussels; Editing by Elaine Hardcastle)

Pfizer, BioNTech launch COVID-19 vaccine trial in kids under 12

By Michael Erman

(Reuters) – Pfizer Inc and German partner BioNTech SE began testing their COVID-19 vaccine in children under 12, with hopes of expanding vaccination to that age range by early 2022, the U.S. drugmaker said on Thursday.

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

The Pfizer/BioNTech vaccine was authorized by U.S. regulators in late December for people age 16 and older. Nearly 66 million doses of the vaccine had been administered in the United States as of Wednesday morning, according to data from the U.S. Centers for Disease Control and Prevention.

The pediatric trial, which will include children as young as 6 months, follows a similar one launched by Moderna Inc last week.

Only the Pfizer/BioNTech vaccine is being used in 16- and 17-year-olds in the United States. Moderna’s shot was cleared for those age 18 and older, and no COVID-19 vaccine has been authorized in younger kids yet.

Pfizer and BioNTech plan to initially test the safety of their two-shot vaccine at three different dosages – 10, 20 and 30 micrograms – in a 144-participant Phase I/II trial.

They plan to later expand to a 4,500-participant late-stage trial in which they will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.

Castillo said the companies hope to have data from the trial in the second half of 2021.

Meanwhile, Pfizer has been testing the vaccine in children from age 12 to 15. The company expects to have data from that trial in the coming weeks, Castillo said.

(Reporting by Michael Erman; Additional reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot)

Pfizer begins early-stage study of oral COVID-19 drug

(Reuters) – Pfizer Inc has started an early-stage U.S. trial of an oral COVID-19 antiviral therapy that could be prescribed to patients at the first sign of infection, the company said on Tuesday.

The drugmaker, which developed the first authorized COVID-19 vaccine in the U.S. with Germany’s BioNTech SA, said the antiviral candidate showed potent activity against SARS-CoV-2, the virus that causes COVID-19, in lab studies.

Pfizer’s candidate, named PF-07321332, is a protease inhibitor that prevents the virus from replicating in cells.

Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.

Pfizer believes this class of molecules may provide well-tolerated treatments against COVID-19, as currently marketed therapeutics that work on the same lines have not reported safety concerns.

The company is also studying an intravenously administered antiviral candidate in an early-stage trial in hospitalized COVID-19 patients.

“Together, the two (oral and intravenous candidates) have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs,” Pfizer’s Chief Medical Officer Mikael Dolsten said in a statement.

Pfizer’s candidate is behind two other oral antiviral therapies, which are in mid-stage trials – the first being developed by rival Merck & Co with Ridgeback Bio, and a second from Roche Holding and Atea Pharmaceuticals.

Gilead Sciences’ remdesivir is currently the only U.S. Food and Drug Administration-approved drug for the treatment of COVID-19.

The FDA has granted an emergency authorization to intravenous therapies from Eli Lilly – bamlanivimab alone and in combination with etesevimab, and a combination therapy from Regeneron.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Shailesh Kuber)

Madrid halting COVID-19 vaccinations due to supply delays

MADRID (Reuters) – Delays to COVID-19 vaccine shipments have forced authorities in Madrid to halt inoculations and are threatening supplies in Catalonia, Spanish officials said on Wednesday.

The Madrid region has ceased first vaccinations for at least this week and next and was using the few doses it has to administer second shots to those who have had the first one, said deputy regional government chief Ignacio Aguado.

“We need more doses and we need them now,” he told reporters on Wednesday, urging newly appointed Health Minister Carolina Darias to act quickly to secure the shots.

U.S. pharmaceutical giant Pfizer said last week there would be a temporary slow down in shipments to the European Union in late January caused by changes to manufacturing processes to ultimately boost output.

The announcement angered some EU governments and the executive European Commission due to the slow pace of vaccine roll outs in the 27-nation bloc.

It is also in dispute with Anglo-Swedish pharmaceutical firm AstraZeneca, which developed its shot with Oxford University and notified the EU on Friday that it could not meet supply targets for the first quarter of the year.

Spain’s 14-day incidence of the virus hit a record 900 cases per 100,000 people on Wednesday and the Health Ministry reported 40,285 new infections and 492 deaths.

Officials in Madrid and Catalonia said at the current pace it would be impossible to reach the national target of 70% of Spain’s 47 million population vaccinated by July.

Catalan health secretary Josep Maria Argimon said the region would use up all its stockpile of vaccines in the coming days and will have to administer second shots later than planned due to supply delays, citing an undelivered shipment of the Moderna vaccine scheduled for this week as one example.

The affluent northeastern region will issue a new request for 30,000 vaccine doses that it expects to administer starting on Feb. 4, Argimon told a news briefing.

Spain has administered just over 1.3 million doses to a priority group of care-home residents and frontline medics, around 77% of its current stocks.

(Reporting by Inti Landauro, Emma Pinedo, Nathan Allen and Joan Faus; Editing by Mark Heinrich and Janet Lawrence)

New York governor asks Pfizer to directly sell COVID-19 vaccine doses

By Kanishka Singh

(Reuters) – New York Governor Andrew Cuomo asked Pfizer Inc Chief Executive Albert Bourla on Monday if the state could buy COVID-19 vaccine doses directly from the U.S. drugmaker.

Pfizer, however, told Reuters that such a proposal would first require approval by the U.S. Department of Health and Human Services.

“With hospitalizations and deaths increasing across the country this winter, we are in a footrace with the virus, and we will lose unless we dramatically increase the number of doses getting to New Yorkers,” Cuomo said in a letter to Pfizer’s CEO.

Cuomo said he was appealing to Pfizer directly as the company was “not bound by commitments” that Moderna Inc made as part of Operation Warp Speed, the U.S. government’s program to distribute COVID-19 vaccines.

No state has purchased vaccines directly from the producer. Cuomo’s letter did not state how many doses he was seeking or how he would pay for it.

Pfizer said it was open to collaborating with the U.S. Department of Health and Human Services in a way that would ensure quick vaccine distribution to as many Americans as possible.

(Reporting by Kanishka Singh in Bengaluru; Editing by Howard Goller)

Mexico aims to make up for Pfizer vaccine shortfall with others

MEXICO CITY (Reuters) – Mexican President Andres Manuel Lopez Obrador said on Monday the government aimed to compensate for a reduction in deliveries of COVID-19 vaccine doses from Pfizer Inc with those from other providers.

The World Health Organization (WHO) said on Monday it was in advanced talks with Pfizer about including its vaccine in the agency’s portfolio of shots to be shared with poorer countries.

Mexico had been expecting weekly deliveries of some 400,000 doses of the Pfizer vaccine developed with Germany’s BioNTech SE. As a result of the U.S. drugmaker’s WHO agreements, Mexico would for now only be receiving half that total, Lopez Obrador told a regular news conference.

It was not clear how long the reduction would last. Pfizer did not immediately reply to a request for comment.

The Pfizer/BioNTech vaccine is currently the only one being administered in Mexico, which has reported the fourth-highest death toll from the pandemic worldwide.

Mexico has also signed deals to acquire vaccines from Britain’s AstraZeneca Plc and China’s CanSino Biologics. Mexico has approved the AstraZeneca shot and expects to have it by March. It is still reviewing the CanSino vaccine.

Lopez Obrador also noted Mexico was about to complete its review of a Russian vaccine, and would soon have it available, an apparent reference to the Sputnik V product.

Mexico suffered a setback to its drive to inoculate the public with the news over the weekend that the official in charge of the program, Miriam Veras Godoy, had stepped down for personal reasons, according to the health ministry.

(Reporting by Raul Cortes; Editing by Bill Berkrot)

Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout

JERUSALEM (Reuters) – Israel is giving weekly data updates on its COVID-19 outbreak to vaccine maker Pfizer under a collaboration agreement that may help other countries fine-tune their inoculation campaigns and achieve “herd immunity,” officials said.

Israelis began receiving first shots of the vaccine developed by Pfizer and its German partner BioNTech on Dec. 19 in one of the world’s fastest vaccination rollouts.

Israel’s Health Ministry made public most of a 20-page collaboration agreement it signed with Pfizer, which said the aim was “to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel”.

Commercial details such as price and quantity of vaccine shots supplied were not made public, but the agreement said that Israel was relying on Pfizer to deliver enough doses at a fast enough rate to allow it to achieve “herd immunity,” meaning a sufficient portion of the population is immune to the virus.

“While this project is conducted in Israel, the insights gained will be applicable around the world and we anticipate will allow governments to maximize the public health impact of their vaccination campaigns,” BioNTech said on Monday in a statement.

This includes determining potential immunization rates needed to stop the virus from spreading, it said.

The goal, BioNTech said, was “to monitor the evolution of the epidemic over time and at different vaccination rates.”

“This will help us understand whether a potential decrease in cases and deaths can be attributed solely to direct vaccine protection or to both direct and indirect (or ‘herd’) protection,” it said.

During weekly status reports, Israel will provide Pfizer with epidemiological data such as: the number of confirmed COVID-19 cases, hospitalizations, how many patients were on ventilators, how many died, as well as an age and other demographic breakdown.

Such data was available to the public and keeps patients anonymous, Israeli officials said.

About a quarter of Israelis have received their first vaccine shot and 3.5% already got their second dose.

Still, the country is in its third lockdown with infection rates remaining high. More than half a million cases have been reported and 4,005 people have died in Israel since the pandemic began.

(Reporting by Ari Rabinovitch, Ludwig Burger, Nikolaj Skydsgaard and Steven Scheer; Editing by Alex Richardson)

Pfizer, U.S. strike 100 million COVID-19 vaccine deal with 70 million due by June

By Ankur Banerjee and Vishwadha Chander

(Reuters) – The U.S. government will pay Pfizer Inc nearly $2 billion for 100 million additional doses of its COVID-19 vaccine to bolster its supply as the country grapples with a nationwide spike in infections.

Under the new agreement, Pfizer will deliver at least 70 million doses by June 30 and the rest no later than July 31, the company said on Wednesday, bringing the total number of doses to 200 million for a total price of about $4 billion.

The purchase price amounts to $19.50 per shot and is slightly higher than the $18.90 per dose that Reuters has reported the European Union has agreed to pay. The shot has been authorized for use in EU and the United States.

The U.S. deal comes after growing concern that the government had not done enough to secure doses of one of the two authorized vaccines, made more pressing amid a COVID-19 surge that has left hospitals struggling to find beds for the sick.

Pfizer’s two-dose vaccine, developed with German partner BioNTech, is being rolled out across the United States after the shot won emergency use authorization earlier this month. The country has also authorized a vaccine from Moderna Inc.

Pfizer and the government have said that they had been negotiating the terms of the agreement, with the company indicating it was trying to work out how to deliver the doses in the second quarter.

Pfizer and BioNTech have said they expect to produce 1.3 billion doses in 2021, but executives at the German biotech have said they were trying to boost manufacturing. Governments around the world are scrambling to get enough supplies of the vaccine to tame the pandemic that has killed about 1.7 million people globally and crushed economies.

“This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021,” U.S. Department of Health and Human Services Secretary Alex Azar said in a statement.

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio.”

Pfizer said last week it may need the U.S. government to help it secure some components needed to make the vaccine. While the company halved its 2020 production target due to manufacturing issues, it said last week its manufacturing is running smoothly now.

The government also has the option to acquire up to an additional 400 million doses of the vaccine.

More than 600,000 Americans have received their first COVID-19 vaccine doses as of Monday, according to the Centers for Disease Control and Prevention (CDC).

The first wave of shots have so far gone to healthcare workers and nursing home residents, as well as some top government officials. Americans in “essential” jobs and those over 75 will likely start to receive vaccines in January while general population vaccinations will start in a few months.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Caroline Humer and Sriraj Kalluvila)

In COVID-19 milestone for West, Britain starts mass vaccination

By Alistair Smout

LONDON (Reuters) – A 90-year-old grandmother became the world’s first person to receive a fully-tested COVID-19 shot on Tuesday, as Britain began mass-vaccinating its people in a global drive that poses one of the biggest logistical challenges in peacetime history.

Health workers started inoculating the most vulnerable with the vaccine developed by Pfizer and BioNTech, with the country a test case for the world as it contends with distributing a compound that must be stored at -70C (-94F).

Margaret Keenan, who turns 91 in a week, was the first to receive the shot, at a hospital in Coventry, central England.

“It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year,” she said.

The launch of the vaccine, one of three shots that have reported successful results from large trials, will fuel hope that the world may be turning a corner in the fight against a pandemic that has killed more than 1.5 million people.

Britain, the worst-hit in Europe with over 61,000 deaths, is the first Western nation to begin mass-vaccinations and the first globally to roll out the Pfizer/BioNTech shot.

But despite the relief of people receiving the first dose of the two-dose regimen, they will have to wait three weeks for their second shot, and there is no evidence immunization will reduce transmission of the virus.

“It will gradually make a huge, huge difference. But I stress gradually, because we’re not there yet. We haven’t defeated this virus yet,” Prime Minister Boris Johnson said.

Health Secretary Matt Hancock said he expected millions to be vaccinated by the end of the year, and described the start of the drive as “V-Day.” But he cautioned people should respect social-distancing rules until spring at least, when he hoped the most vulnerable people would be vaccinated.

The country has ordered enough supplies of the Pfizer/BioNTech shot to vaccinate 20 million people. The developers said it was 95% effective in preventing illness in final-stage trials.

Russia and China have both already started giving domestically produced vaccine candidates to their populations, though before final safety and efficacy trials have been completed.

FIVE DAYS IN A FRIDGE

In Britain, about 800,000 doses are expected to be available within the first week, with care-home residents and carers, the over-80s and some health workers prioritized. Hancock said he had a “high degree of confidence” Britain would take delivery of another batch of the vaccine next week.

“I know we’re absolutely bursting at the doors with COVID patients, so I more than anybody wants it to happen quickly,” said Ami Jones, a hospital intensive-care consultant from Wales who received the jab before going to work.

The country is relatively small with good infrastructure. Yet the logistical challenges in distributing the vaccine, which only lasts five days in a regular fridge, mean it will first go to dozens of hospitals and cannot yet be taken into care homes.

Bigger tests could await for the Pfizer/BioNTech shot, as well as a vaccine from Moderna, which was found to have a similar level of success in trials and is based on the same mRNA genetic technology that requires such ultra-cold storage.

Transport and distribution could prove more challenging in hot countries and bigger nations such as the United States and India, which have been worst-hit by COVID-19 and are expected to approve the shot for emergency use in the coming days or weeks.

South Korea, which has coped relatively well with the pandemic, sounded a note of caution, saying it would not hurry vaccine rollouts, partly to give it time to observe potential side-effects in other countries. Vaccinations may start in the first half of 2021, the health ministry added.

The third vaccine to have had trial success, developed by AstraZeneca and Oxford University, is viewed as offering one of the best hopes for many developing countries because it is cheaper and can be transported at normal fridge temperatures. Late-stage trials found it had an average success rate of 70%.

Britain hopes for regulatory approval of the Oxford/AstraZeneca shot in the next couple of weeks.

A SHOT FOR SHAKESPEARE

Britain approved the Pfizer/BioNTech vaccine for emergency use less than a week ago, and is rolling it out ahead of the United States and European Union.

The Pfizer/BioNTech vaccine is being imported from Belgium, while initial supplies of the AstraZeneca/Oxford shot are being shipped from Germany.

“Of course, it adds complexity,” Steve Bates, chief executive of the BioIndustry Association, told reporters of the possible impact of Brexit. “But there is a robust plan for alternative routes and mitigation.”

In total Britain has ordered 40 million doses of the Pfizer/BioNTech shot, enough to vaccinate 20 million people in the country of 67 million. It has ordered 357 million doses of seven different COVID-19 vaccines in all.

Amid the gravity of the pandemic, the vaccination on Tuesday of one William Shakespeare, an 81-year-old of Warwickshire in England, was greeted with humor on social media.

Twitter users joked about “The Taming of the Flu” and “The Two Gentlemen of Corona”. Some asked, if Margaret Keenan was patient 1A, was Shakespeare “Patient 2B or not 2B?”.

(Reporting by Alistair Smout; Additional reporting by Sarah Young, Kate Holton and Natalie Thomas; Editing by Guy Faulconbridge and Pravin Char)

Moderna to seek U.S. and EU authorization for its vaccine on Monday

By Julie Steenhuysen and Michael Erman

(Reuters) – Moderna Inc will apply for U.S. and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said.

Moderna also reported that its vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna’s product up to be the second vaccine likely to receive U.S. emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate.

“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said. “We expect to be playing a major part in turning around this pandemic.”

Of the 196 people who contracted COVID-19 out of over 30,000 volunteers, 185 had received a placebo and 11 got the vaccine. Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective against severe cases.

Moderna shares opened 13% higher at a record $144 following the results and then went on to hit a peak of $150.14, or a gain of 668% so far this year.

“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.

In addition to filing its U.S. application, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data, and would continue to talk with other regulators doing similar rolling reviews.

“Although we await the full details of these results in published form, we can now assume that this vaccine will be approved for use in December,” said Gillies O’Bryan-Tear, chair of policy and communications at Britain’s Faculty of Pharmaceutical Medicine.

He expected Britain’s Medicines and Healthcare products Regulatory Agency to approve the vaccine within two weeks.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

‘JUST OVERWHELMING’

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Switzerland’s Lonza, which has a contract with Moderna to supply ingredients for the vaccine, rose 4.4%.

The vaccines developed by both Moderna and Pfizer/BioNTech use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain’s AstraZeneca, are using more traditional methods.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov. 16 of 94.5% effectiveness, a difference that Zaks said was not statistically significant.

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50% benchmark set by the U.S. Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and come as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on Dec. 10 to review Pfizer’s data and make a recommendation to the U.S. regulator. They will review Moderna’s data a week later.

Soon after getting the green light, Moderna expects its vaccine to be shipped to distribution points across the United States by the government’s Operation Warp Speed program and drug distributor McKesson Corp.

The distribution is expected to be easier than Pfizer’s because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.

CONSISTENT ACROSS AGE AND ETHNICITY

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 in the placebo group during the trial.

“This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” said Moderna’s Zaks.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details confirmed the vaccine was highly effective, including against severe cases.

“Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.

Moderna reported no new side effects since its interim analysis, which showed the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants which, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far, he said.

Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021. It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

(Reporting by Julie Steenhuysen and Michael Erman; Additional reporting by Ankur Banerjee and Manas Mishra in Bengaluru and Kate Kelland in London; Editing by Bill Berkrot, Edwina Gibbs and David Clarke)