Tag Archives: Pfizer Inc

Fauci stresses on need for equitable access of COVID-19 vaccines

(Reuters) – U.S. infectious disease expert Anthony Fauci said on Thursday vaccine developers should push to make billions of their COVID-19 vaccines to ensure access to all parts of the world, instead of focusing on the rich countries.

Fauci’s comments come days after Pfizer Inc said its COVID-19 vaccine candidate was more than 90% effective based on initial results from a large-scale trial, securing a lead in the race to develop a safe and effective vaccine for the respiratory illness.

Pfizer has a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year, as well as a deal with the European Union to supply up to 300 million doses.

“Now a number of different companies are talking about the ability to make billions of doses. That’s what we need. We don’t need hundreds of millions for the rich countries,” Fauci said at a webinar conducted by British think tank Chatham House.

“We need billions (of vaccine doses), so whether you live in the darkest part of the developing world, or if you live in London, you should have the same access.”

Experts have also raised doubts about access to the vaccine, especially in the developing countries, as it needs to be stored at temperatures of minus 70 degrees Celsius (-94 F) or below, posing infrastructure challenges.

“Certainly it is not going to be pandemic for a lot longer, because I believe the vaccines are going to turn that around,” Fauci said, while adding that there may be a need to re-vaccinate people intermittently, if COVID-19 becomes endemic.

Fauci said efforts were underway in the United States to push for the development of antivirals and other therapies for early intervention during the course of the COVID-19 respiratory illness.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta)

Europe COVID death toll tops 300,000 as winter looms and infections surge

By Shaina Ahluwalia, Anurag Maan and Roshan Abraham

(Reuters) – More than 300,000 people have died of COVID-19 across Europe, according to a Reuters tally on Tuesday, and authorities fear that fatalities and infections will continue to rise as the region heads into winter despite hopes for a new vaccine.

With just 10% of the world’s population, Europe accounts for almost a quarter of the 1.2 million deaths globally, and even its well-equipped hospitals are feeling the strain.

After achieving a measure of control over the pandemic with broad lockdowns earlier this year, case numbers have surged since the summer and governments have ordered a second series of restrictions to limit social contacts.

In all, Europe has reported some 12.8 million cases and about 300,114 deaths. Over the past week, it has seen 280,000 cases a day, up 10% from the week earlier, representing just over half of all new infections reported globally.

Hopes have been raised by Pfizer Inc’s announcement of a potentially effective new vaccine, but it is not expected to be generally available before 2021 and health systems will have to cope with the winter months unaided.

Britain, which has imposed a fresh lockdown in England, has the highest death toll in Europe at around 49,000, and health experts have warned that with a current average of more than 20,000 cases daily, the country will exceed its “worst case” scenario of 80,000 deaths.

France, Spain, Italy and Russia have also reported hundreds of deaths a day and together, the five countries account for almost three quarters of the total fatalities.

Already facing the prospect of a wave of job losses and business failures, governments across the region have been forced to order control measures including local curfews, closing non-essential shops and restricting movement.

France, the worst-affected country in the EU, has registered more than 48,700 infections per day over the past week and the Paris region’s health authority said last week that 92% of its ICU capacity was occupied.

Facing similar pressures, Belgian and Dutch hospitals have been forced to send some severely ill patients to Germany.

In Italy, which became a global symbol of the crisis when army trucks were used to transport the dead during the early months of the pandemic, daily average new cases are at a peak at more than 32,500. Deaths have been rising by more than 320 per day over the past three weeks.

While the new vaccine being developed by Pfizer and German partner BioNTech will take time to arrive, authorities are hoping that once winter is passed, it will stem further outbreaks next year.

Citi Private Bank analysts described the news as “the first major advance toward a Post-COVID world economy”.

“More than any fiscal spending package or central bank lending program, a healthcare solution to COVID has the greatest potential to restore economic activity to its full potential…” it said in a note.

European Commission President Ursula von der Leyen on Monday said the European Union would soon sign a contract for 300 million doses of the vaccine, just hours after the drugmaker announced promising late-stage trials.

Yet health experts cautioned that the vaccine, should it be approved, was no silver bullet – not least because the genetic material it’s made from needs to be stored at temperatures of minus 70 degrees Celsius (-94 F) or below.

Such requirements pose a challenge for countries in Asia, as well as Africa and Latin America, where intense heat is often compounded by poor infrastructure.

(Reporting by Anurag Maan, Shaina Ahluwalia, Chaithra J and Roshan Abraham in Bengaluru, Sujata Rao-Coverley in London; editing by Jane Wardell, James Mackenzie, Nick Macfie and Mike Collett-White)

India sees early vaccine launch as AstraZeneca deliveries run late

By Krishna N. Das

NEW DELHI (Reuters) – India raced ahead with work on its coronavirus vaccine while Britain’s AstraZeneca said its deliveries were running “a little bit late” as countries around the world sought to conquer the pandemic and rescue their economies.

A vaccine is seen as the world’s best bet for taming a virus that has infected more than 48 million people, led to more than 1.2 million deaths, roiled economies and disrupted billions of lives since it was first identified in China in December.

Australia is beefing up its prospective arsenal against the pandemic to 135 million doses of various vaccine candidates.

“We aren’t putting all our eggs in one basket,” Prime Minister Scott Morrison said on Thursday.

Some 45 vaccine candidates are in human trials worldwide, with Pfizer Inc saying it could file in late November for U.S. authorization, opening up the possibility of a vaccine being available in the United States by the end of the year.

Moderna and AstraZeneca are close behind the largest U.S. drugmaker and are likely to have early data on their vaccine candidates before the end of the year.

An Indian government-backed vaccine could be launched as early as February – months earlier than expected – as last-stage trials begin this month and studies have so far showed it is safe and effective, a senior government scientist told Reuters.

Bharat Biotech, a private company that is developing COVAXIN with the government-run Indian Council of Medical Research (ICMR), had earlier hoped to launch it only in the second quarter of next year.

“The vaccine has shown good efficacy,” senior ICMR scientist Rajni Kant, who is also a member of its COVID-19 task force, said at the research body’s New Delhi headquarters.

“It is expected that by the beginning of next year, February or March, something would be available.”

Bharat Biotech could not immediately be contacted.

A launch in February would make COVAXIN the first India-made vaccine to be rolled out.

VACCINE KEPT FROZEN

AstraZeneca has signed multiple deals to supply more than three billion doses of its candidate to countries around the world.

But a summer dip in British coronavirus infections had pushed back test results, leading the drugmaker to delay deliveries of shots to the government.

Britain’s vaccines chief said on Wednesday it would receive just 4 million doses of the potential vaccine this year, against initial estimates for 30 million by Sept. 30.

AstraZeneca said on Thursday it was holding back deliveries while it awaits the data from late-stage clinical trials in order to maximize the shelf-life of supplies.

“We are a little bit late in deliveries, which is why the vaccine has been kept in frozen form,” CEO Pascal Soriot said on a conference call.

AstraZeneca and its partner on the project, the University of Oxford, said that data from late-stage trials should land this year.

The United States leads the world in both the number of COVID deaths and infections and the pandemic was a polarizing issue in Tuesday’s presidential election in which votes were still being counted.

Australia’s Morrison said the government would buy 40 million vaccine doses from Novavax and 10 million from Pfizer and BioNTech.

That adds to the 85 million doses Australia has already committed to buy from AstraZeneca and CSL Ltd should trials prove successful.

Among other vaccine candidates around the world, a growing number of Russians are unwilling to be inoculated once a vaccine becomes widely available, the Levada Centre, Russia’s only major independent pollster, said this week.

Russia, raising eyebrows in the West, is rolling out its “Sputnik V” vaccine for domestic use despite the fact that late-stage trials have not yet finished.

(Reporting by Reuters bureaus; Writing by Nick Macfie; Editing by Angus MacSwan)

Moderna would seek limited emergency use of COVID-19 vaccine based on early data

By Julie Steenhuysen

CHICAGO (Reuters) – If Moderna Inc’s COVID-19 vaccine proves to be at least 70 percent effective, the company plans to seek emergency authorization for its use in high-risk groups, the company’s chief executive told Reuters.

Moderna’s vaccine candidate – mRNA-1273 – is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who didn’t.

Vaccines must demonstrate they are at least 50% more effective than a placebo to be considered for approval. To prove that, government officials have said, at least 150 COVID-19 infections must be recorded among trial participants with at least twice as many occurring among the placebo group.

If a vaccine is especially effective, companies could have their answer sooner.

An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.

If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).

“If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval,” Stephane Bancel, Moderna’s chief executive officer, said in a telephone interview.

“At such a level of efficacy, if we get there, we can protect a lot of lives in the people at the highest risk, and so, we will consider filing for an EUA for a very limited population,” Bancel said.

He said the FDA will determine whether the benefit of the vaccine to a small group of high-risk individuals outweighs the risk of not having a full readout of safety data from all 30,000 study participants.

The two groups of high-risk individuals who might be covered in such an EUA would be healthcare workers and the elderly, Bancel said.

Bancel said the company wants to gather more data on the safety of the vaccine in the study population over a period of several months before seeking full FDA approval.

Moderna released its study protocol on Thursday, making public details on how its vaccine will be evaluated. If the vaccine does not reach the efficacy mark after 53 cases, the data safety and monitoring board will take another interim look at the data after 106 cases, and a final look after 151 people in the trial become infected with the virus.

Public health officials have said that approving a vaccine for widespread use based on a small number of cases would not offer enough safety information to show how the vaccine would perform.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.

In a presentation to investors on Tuesday, Pfizer Inc said the company has enrolled more than 29,000 people in its 44,000-volunteer trial to test an experimental COVID-19 vaccine the company is developing with German partner BioNTech.

Pfizer expects to have enough data to show whether the vaccine works by the end of October.

(Reporting by Julie Steenhuysen; editing by Peter Henderson and Cynthia Osterman)

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)

Pfizer to make Gilead’s COVID-19 treatment remdesivir

(Reuters) – Pfizer Inc said on Friday it signed a multiyear agreement to make COVID-19 treatment remdesivir for developer Gilead Sciences Inc, which is under pressure to increase tight supplies of the antiviral drug.

Gilead is aiming to make enough of the drug by the end of the year to treat more than 2 million COVID-19 patients, and agreed to send nearly all of its remdesivir supply to the United States through September.

But hospital staffers and politicians have complained about difficulties in gaining access to the drug, which is one of only two to have demonstrated an ability to help hospitalized COVID-19 patients in formal clinical trials.

There are also fears of shortages outside the United States, and separately on Friday, Britain’s Hikma Pharmaceuticals PLC said it has started manufacturing remdesivir at its Portugal plant.

Gilead said its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia to add capacity.

Earlier this week, a bipartisan group of U.S. state attorneys general urged the federal government to allow other companies to make Gilead’s remdesivir, to increase its availability and lower the price of the antiviral drug.

Pfizer will provide contract manufacturing services through its McPherson, Kansas, plant, the drugmaker said. It was not immediately clear if Pfizer would supply only for the U.S. market.

The U.S. Food and Drug Administration sent a warning letter to Pfizer in 2017 saying that the process for manufacturing sterile injectable drugs at the Kansas plant was “out of control” and put patients at risk.

The FDA said several products were contaminated with multiple foreign particulates but a subsequent FDA inspection found that the issues had been resolved.

Pfizer, with Germany’s BioNTech, is also rushing to develop a vaccine against the coronavirus.

Pfizer has helped other drugmakers manufacture their products before. It makes EpiPen emergency allergy treatments through its Meridian Medical Technologies business and also operates a contract manufacturer called Center One.

(Reporting by Manas Mishra in Bengaluru; Editing by Anil D’Silva and Matthew Lewis)