Tag Archives: pfizer

Moderna on track to report COVID-19 vaccine data later this month

By Manas Mishra and Dania Nadeem

(Reuters) – Moderna Inc. said on Wednesday it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file for U.S. emergency use authorization in early December.

The company may have to wait for a two-month follow up safety data to apply for U.S. emergency use authorization, even after reporting positive interim data on the vaccine’s effectiveness.

Moderna said it expects the safety data in the second half of this month.

Hopes of the world soon getting an effective vaccine against the virus that has killed over a million people were raised on Monday after Pfizer Inc. said its COVID-19 vaccine was more than 90% effective based on interim trial results.

There are no vaccines that have gained global approval yet, although a handful, including Moderna’s, are in late-stage studies.

It was too early to guess how effective Moderna’s vaccine could be, Chief Executive Officer Stephane Bancel said at a Credit Suisse conference.

The world would have to wait for more data to understand whether use of a particular vaccine would be more widespread, Bancel said.

Moderna, which uses a technology similar to Pfizer’s, finished enrolling 30,000 volunteers in its late-stage study last month.

Public health experts have said it is likely that more than one vaccine would be needed to control the pandemic.

(Reporting by Manas Mishra and Dania Nadeem in Bengaluru; Editing by Krishna Chandra Eluri, Saumyadeb Chakrabarty and Sriraj Kalluvila)

Q&A: Where are we in the COVID-19 vaccine race?

(Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over 1.26 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE were the first to release data showing on Monday that their vaccine worked in a large, late-stage clinical trial.

Russia’s sovereign wealth fund published interim late-stage trial results for its Sputnik V vaccine on Wednesday showing the shot is 92% effective at protecting people from COVID-19.

The next data releases will likely be from U.S. biotech firm Moderna Inc, possibly in November, and from Britain-based AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why is Pfizer ahead with its data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer said its interim analysis was conducted after 94 participants in the trial developed COVID-19 while Russia’s examination was conducted after 20 participants in the trial developed the disease.

AstraZeneca said last week a slowdown in infections during the summer is delaying data analysis for its UK trial.

COVID-19 cases, however, soared in October and early November, setting daily records in the United States and Europe.

How well are the vaccines supposed to work?

The World Health Organization has recommended a minimum standard for effectiveness of at least 50%. The United States and some other regulators are following that guideline – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

Pfizer and Russia both said their vaccines are more than 90% effective against COVID-19.

When will regulators rule on safety and efficacy?

Regulators review vaccines after companies submit applications seeking either emergency use authorization (EUA) or formal approval.

The earliest the U.S. Food and Drug Administration could make a decision is in December because Pfizer/BioNTech and Moderna do not expect to have enough safety data until the second half of November. The FDA has asked companies to watch trial participants for side effects for two months after receiving a final vaccine dose.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to conduct expedited reviews as well. It is not clear when companies will submit efficacy data to these agencies or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China is on a similar timeline. The country launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people.

At least four vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

In late October, the director of the Gamaleya Institute, Alexander Gintsburg, said 20,000 volunteers had received the first shot so far and 9,000 the second.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer, Bill Berkrot, Edwina Gibbs, David Clarke and Josephine Mason)

U.S. has a plan to start Pfizer vaccine shots in December: Health Secretary Azar

By Doina Chiacu and Deena Beasley

WASHINGTON (Reuters) – If Pfizer Inc. submits the positive initial data from its COVID-19 vaccine trial to health regulators as quickly as expected, the U.S. government plans to begin vaccinating Americans in December, Health Secretary Alex Azar said on Tuesday.

Pfizer on Monday said the vaccine it has been developing with German partner BioNTech SE was 90% effective against COVID-19, based on an early look at results from its large, late-stage trial.

The U.S. drugmaker said it expects to have safety data as soon as next week that it needs to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration.

Upon FDA authorization, the United States would receive about 20 million doses of the Pfizer vaccine per month, Azar said on a call with reporters, noting that HHS could being procuring supplies at the end of this month.

The United States has a $1.95 billion contract for 100 million doses of the Pfizer vaccine – enough to inoculate 50 million people – with an option to acquire 500 million more.

Earlier on Tuesday, Azar said on CNBC that final decisions are subject to a close look at the vaccine efficacy data.

Based on recommendations to the government, it will likely start with inoculations of the elderly in nursing homes and assisted living facilities, healthcare workers and first responders, with a goal to complete those shots by the end of January.

Top U.S. infectious disease expert Anthony Fauci also said in an interview with MSNBC that he expects the doses of the vaccine to be available for certain high priority groups in December.

Azar said he anticipates there will soon be more vaccines to protect against COVID-19 from other companies, including Moderna Inc <MRNA.O>, which is expected to announce interim results of a large trial of its experimental vaccine at the end of the month.

“By the end of March, early April, we expect to have enough for every American who would like to be vaccinated,” Azar told CBNC.

ANTIBODY DRUG DISTRIBUTION

Azar also said the U.S. government would begin distribution of Eli Lilly and Co’s antibody treatment this week, starting first in areas with the highest numbers of hospitalized COVID-19 patients and overall cases.

The treatment, which is administered by infusion, received an EUA on Monday.

“We’ll ensure equitable distribution, and we’ll work tightly with our governors,” Azar said. He said the government will use the same process employed to distribute remdesivir, an antiviral drug from Gilead Sciences Inc used to treat people hospitalized with COVID-19.

According to the Health and Human Services website, the agency will ship more than 79,000 doses of the antibody therapy this week, with the largest number going to Wisconsin, Texas, California, and Illinois.

The United States has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.

Azar said health officials and Eli Lilly were exploring ways to provide the treatment outside of hospitals, including through outpatient infusion centers.

Fauci described the Lilly treatment as “an important first step in the development and distribution of interventions that are given early in the course of disease.”

(Reporting by Doina Chiacu in Washington, Caroline Humer and Carl O’Donnell in New York, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; Editing by Andrew Heavens, Alexandra Hudson and Bill Berkrot)

We may soon have a COVID-19 vaccine. But will enough people take it?

By John Miller and Kate Kelland

ZURICH/LONDON (Reuters) – With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated.

Public resistance to vaccines has been much discussed this year, but the issue became very real on Monday when Pfizer and BioNTech announced their candidate was more than 90% effective in large trials – hoisting an actual shot onto the horizon.

Numerous opinion polls carried out before and during the pandemic showed confidence is volatile, and that political polarization and online misinformation threatens uptake. Many people have concerns about the accelerated speed of COVID-19 vaccine development.

The World Health Organization estimates about 70% of people must be inoculated to break transmission of the virus. Since it is unlikely a vaccine, once approved, will be immediately available for the masses, experts said getting medical workers on board will be critical.

“We should have really targeted discussions and engagement with healthcare providers,” Heidi Larson, director of the global Vaccine Confidence Project, told Reuters.

“Not only are they going to be the first ones expected to get a vaccine – if not required to – they’re also going to be the ones on the frontlines facing the onslaught of questions from the public.”

FIRST IN LINE?

While about 200 COVID-19 vaccine candidates are in development globally, with dozens in human clinical trials, no shot has actually crossed the finish line and been approved, though the one from Pfizer-BioNTech appears to be on track.

The high rate of efficacy in the Pfizer-BioNTech interim results could help boost confidence, Cornell University government Professors Douglas Kriner and Sarah Kreps said.

Their recently published research showed that if an initial COVID-19 vaccine was about as effective as a flu shot, uptake by the American public may fall far short of the 70% level needed to achieve “herd immunity.”

“However, if the vaccine was 90% effective it would significantly increase Americans’ willingness to vaccinate by more than 10%, critical to ensuring enough public acceptance to help the U.S. eventually get closer to herd immunity,” said Kreps.

Experts are also cautioning any conversation over a vaccine’s risks and rewards must be frank. A return to normal life will still take time, with no one shot likely to be a silver bullet. And many questions are likely to remain, including how long a vaccine will provide protection.

The Reagan-Udall Foundation for the FDA, a non-profit that supports the U.S. Food and Drug Administration, has been holding focus groups to gauge the public mood and is now crafting campaign messages to help tackle concerns.

Its chief executive, Susan Winckler, said more than a dozen focus groups of 150 people in total held since August – some in person, some by video – had unearthed numerous concerns.

“We heard distrust of both government and the healthcare system,” Winckler said. “Many didn’t want to be first in line for the shot.”

It’s a global phenomenon; a survey from early November, carried out by the World Economic Forum and covering 18,526 people in 15 countries, showed 73% of people willing to get a COVID-19 vaccine, a four-point fall since August.

EARLY BATTLE

Regulators and the drug industry have taken pains to reassure the public they won’t cut corners on safety, with a top U.S. drug agency official saying he would quit if an unproven vaccine were rubber stamped.

The International Federation of Pharmaceutical Manufacturers & Associations, a drug industry group, also plans a campaign by 2021, while the U.S. Council for International Business, with 300 multinational corporations as members, is also getting behind a campaign pushing for workforce take-up of eventual COVID-19 vaccines.

Some studies show government and employer recommendations will help convince people to get vaccinated.

Scott Ratzan, co-leader with Larson of ‘CONVINCE’, an initiative supporting communication and engagement for vaccine uptake globally, stressed the importance of medical workers getting inoculated, saying others would then be more likely to follow suit.

“If we don’t have the medical folks signed on … we’ll lose the early battle,” he added. “The only way to get back to normal is if we can get enough workers or employees covered.”

(Reporting by John Miller in Zurich and Kate Kelland in London; Additional reporting by Martinne Geller in London, Doug Busvine in Frankfurt and Julie Steenhuysen in Chicago; Editing by Josephine Mason and Pravin Char)

‘Great day for humanity’: Pfizer says COVID-19 vaccine over 90% effective

By Michael Erman and Julie Steenhuysen

(Reuters) – Pfizer Inc’s experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.

Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.

Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance of a regulatory decision as soon as December.

If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

“Today is a great day for science and humanity,” said Pfizer Chief Executive Albert Bourla.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he said.

Experts said they still wanted to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.

“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and face covering set to remain for the foreseeable future.

Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which is expected in the third week of November.

U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.

MARKETS SURGE

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil companies and travel companies soared. Shares in companies that have thrived during lockdowns, such as conferencing platform Zoom Video and online retailers, tumbled.

Pfizer shares jumped more than 11% to their highest since July last year, while BioNTech’s stock hit a record high.

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson up 4% and Moderna Inc, whose vaccine uses a similar technology as the Pfizer shot, up 8%. Britain’s AstraZeneca, however, fell 2%. Moderna is expected to report results from its large-scale trial later this month.

“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”

U.S. President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he tweeted.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

The World Health Organization said the results were very positive, but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.

‘NEAR ECSTATIC’

“I’m near ecstatic,” Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. “This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”

Between 55% and 65% of the population will need to be vaccinated to break the dynamic of the spread of COVID-19, said Germany’s health minister Jens Spahn, adding that he did not expect a shot to be available before the first quarter of 2021.

The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.

The companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration’s Operation Warp Speed vaccine program.

The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.

Pfizer said the interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo.

Pfizer did not break down how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.

The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.

Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.

MORE DATA NEEDED

To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.

Pfizer said its data would be peer reviewed once it has results from the entire trial.

“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany.

Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million cases since the new coronavirus first emerged late last year in China.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.

(Reporting by Michael Erman and Julie Steenhuysen; Additional reporting by Michele Gershberg in New York, Ludwig Burger and Patricia Weiss in Frankfurt and Kate Kelland in London; Editing by Bill Berkrot, Caroline Humer, Edwina Gibbs and David Clarke)

Pfizer says earliest COVID-19 vaccine application to U.S. regulators would be after election

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the U.S. election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000 person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall.

The president’s rush to a vaccine has also raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

U.S. health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalized a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its time line raise the possibility of U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s U.S. trial has been on hold since September.

After the FDA announced the two-month requirement on Oct. 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov. 3., Trump called the move a ‘political hit job.’

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1% in premarket trading, while BioNTech’s U.S-listed shares were up 4% before the opening bell. Moderna was unchanged and U.S. futures were higher.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey, Patricia Weiss in Frankfurt; writing by Caroline Humer in New York; Editing by Patrick Graham, Saumyadeb Chakrabarty and Steve Orlofsky)

Exclusive: New global lab network will compare COVID-19 vaccines head-to-head

By Kate Kelland

LONDON (Reuters) – A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots.

Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic.

The centralized network is the first of its kind to be set up in response to a pandemic.

In a network spanning Europe, Asia and North America, the labs will centralize analysis of samples from trials of COVID-19 candidates “as though vaccines are all being tested under one roof”, Saville said, aiming to minimize the risk of variation in results.

“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents – so while you get a readout, the ability to compare between different candidates is very difficult,” she told Reuters.

“By taking the centralized lab approach … it will give us a chance to really make sure we are comparing apples with apples.”

The CEPI network will initially involve six labs, one each in Canada, Britain, Italy, the Netherlands, Bangladesh and India, Saville said.

Hundreds of potential COVID-19 vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer, Moderna and AstraZeneca likely to have final-stage trial results before year-end.

Typically, the immunogenicity of potential vaccines is assessed in individual lab analyses, which aim to see whether biomarkers of immune response – such as antibodies and T-cell responses – are produced after clinical trial volunteers receive a dose, or doses, of the vaccine candidate.

But with more than 320 COVID-19 vaccine candidates in the works, Saville said, the many differences in data collection and evaluation methods are an issue.

As well as potential variations in markers of immunity, there are differences in how and where samples are collected, transported and stored – all of which can impact the quality and usefulness of the data produced, and make comparisons tricky.

And with a range of different vaccine technologies being explored – from viral vector vaccines to ones based on messenger RNA – standard evaluation of their true potential “becomes very complex”, she said.

“With hundreds of COVID-19 vaccines in development … it’s essential that we have a system that can reliably evaluate and compare the immune response of candidates currently undergoing testing,” she said.

By centralizing the analysis in a lab network, much of what Saville called the “inter-laboratory variability” can be removed, allowing for head-to-head comparisons.

CEPI says all developers of potential COVID-19 vaccines can use the centralized lab network for free to assess their candidates against a common protocol. For now, the network will assess samples from early-stage vaccine candidate testing and first and second stage human trials, but CEPI said it hoped to expand its capacity to late stage (Phase III) trial data in the coming months.

Results produced by the network will be sent back to the developer, with neither CEPI nor the network owning the data.

CEPI itself is co-funding nine of the potential COVID-19 vaccines in development, including candidates from Moderna, AstraZeneca, Novavax and CureVac.

(Reporting by Kate Kelland, editing by Mark Potter)

Explainer: When will COVID-19 vaccines be generally available in the U.S.?

By Carl O’Donnell and Michael Erman

(Reuters) – U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) this week disagreed about when a COVID-19 vaccine would become widely available. Trump has said one could initially be available by the Nov. 3 election, while the CDC director said vaccines were likely to reach the general public around mid-2021, an assessment more in line with most experts.

WHAT DOES IT MEAN FOR A VACCINE TO BE GENERALLY AVAILABLE?

General availability is when every American who wants the vaccine can get it. There are currently no COVID-19 vaccines approved by U.S. regulators, although a handful are in late-stage trials to prove they are safe and effective.

Experts estimate that at least 70% of roughly 330 million Americans would need to be immune through a vaccine or prior infection to achieve what is known as herd immunity, which occurs when enough people are immune to prevent the spread of the virus to those unable to get a vaccine.

HOW LONG BEFORE VACCINE PRODUCTION IS FULLY RAMPED UP?

Most vaccines in development will require two doses per person.

The CDC anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year. The current front runners are Pfizer Inc and Moderna Inc.

Drugmakers have been more ambitious with their calculations. AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States by as early as October. Pfizer and German partner BioNTech SE have said they expect to have 100 million doses available worldwide by the end of 2020, but did not specify how much of that was earmarked for the United States. Moderna on Friday said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021.

Obtaining enough doses to inoculate everyone in the United States will likely take until later in 2021. CDC Director Robert Redfield told a congressional hearing on Wednesday that vaccines may not be widely available to everyone in the United States until the second or third quarter of next year.

WHO WOULD GET AN APPROVED VACCINE FIRST?

The CDC decision will likely broadly follow recommendations from the National Academies of Sciences, Engineering and Medicine. The CDC has said the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, and essential workers.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have filed with regulators seeking to start recruiting volunteers as young as 16 for vaccine studies.

WHICH COMPANIES WILL LIKELY ROLL OUT A VACCINE QUICKLY?

Pfizer has said it could have compelling evidence that its vaccine works by the end of October. Moderna says it could have similar evidence in November. The vaccines would first need to be approved or authorized for emergency use by U.S. regulators.

Drugmakers have already started manufacturing supplies of their vaccine candidates to be ready as soon as they get the go ahead. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have all said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

(Reporting by Carl O’Donnell and Michael Erman in New York; additional reporting by Caroline Humer; editing by Peter Henderson and Bill Berkrot)

Philippines presidential spokesman links pardon of U.S. Marine to vaccine access

MANILA (Reuters) – Philippine President Rodrigo Duterte’s decision to pardon a United States Marine convicted of killing a transgender woman nearly six years ago may have stemmed from his desire to get access to coronavirus vaccines being developed by U.S. firms, his spokesman said on Thursday.

“His decision didn’t surprise me. Why? Because I know he is upholding the higher national interest”, Harry Roque said in a regular news briefing when asked to give his “personal take” on the president’s move.

Duterte on Monday pardoned Lance Corporal Joseph Scott Pemberton who was serving a six- to 10-year sentence for killing Jennifer Laude near a former U.S. navy base in 2014, sparking condemnation from activists who described the move as a “mockery of justice”.

Roque, who served as lawyer in the prosecution of Pemberton, had likened Laude’s killing to the “death of Philippine sovereignty”.

“I think this pardon, although this is my personal opinion, was to ensure Filipinos would benefit from a vaccine against COVID-19 should the Americans develop one,” Roque said. “I don’t see any problem with that”.

The Philippines, among a number of developing countries with large populations keen to secure a supply a COVID-19 vaccine, met with representatives of U.S. drugmaker Pfizer Inc last week.

U.S. public health officials and Pfizer said a COVID-19 vaccine could be ready for distribution in the United States as soon as next month

Duterte has pledged that the country, which has the most coronavirus infections and second largest number of COVID-19 deaths in Southeast Asia, would be “back to normal” by December, pinning his hopes on access to affordable vaccines from countries like China and Russia.

The Southeast Asian nation, which has more than 248,000 confirmed COVID-19 cases, plans to buy 40 million doses worth $400 million for 20 million people, about a fifth of its 107 million population.

(Reporting by Karen Lema; editing by Philippa Fletcher)

U.S., European COVID vaccine developers pledge to uphold testing rigor

By Ludwig Burger, Patricia Weiss and Caroline Copley

FRANKFURT (Reuters) – Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.

The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.

The companies said in a statement they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”.

The other signatories were Johnson & Johnson, Merck & Co., Moderna, Novavax, Sanofi and BioNTech.

The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jump start global business and trade.

The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials – large-scale testing intended to demonstrate safety and efficacy – as long as officials are convinced the benefits outweigh the risks.

This prompted a call for caution from the World Health Organization (WHO).

Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.

The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.

Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

PROMISE ON SAFETY AND EFFICACY

“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.

“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”

BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter U.S. politics before the Nov. 3 presidential election.

President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.

The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.

BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.

The development race has intensified safety concerns about an inoculation, polls have shown.

Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.

Sahin declined to comment on regulators specifically or on what events prompted the joint statement.

The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.

“What Russia did – and maybe also there are tendencies in the U.S. to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.

“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”

Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing.

(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and Caroline Copley in Berlin; Editing by Susan Fenton and Timothy Heritage)