4.2 million COVID-19 cases in November

WASHINGTON (Reuters) – The United States entered the final month of the year hoping that promising vaccine candidates will soon be approved to halt the rapidly spreading novel coronavirus after 4.2 million new cases were reported in November.

The new COVID-19 cases were more than double the previous monthly record set in October, as large numbers of Americans still refuse to refuse to wear masks and continue to gather in holiday crowds, against the recommendation of experts.

A Food and Drug Administration panel of outside advisers will meet on Dec. 10 to discuss whether to recommend the FDA authorize emergency use of a vaccine developed by Pfizer Inc.

A second candidate from Moderna Inc could follow a week later, officials have said, raising hopes that Americans could start receiving inoculations before the end the year, although widespread vaccinations could take months.

Other global pharmaceuticals including AstraZeneca PLC and Johnson & Johnson also have vaccines in the works, leading a member of the Trump administration’s “Operation Warp Speed” program to predict the country could be vaccinated by June.

“One hundred percent of the Americans that want the vaccine will have the vaccine by (June). We will have over 300 million doses available to the American public well before then,” Paul Ostrowski, the vaccine program’s director of supply, production and distribution, told MSNBC television on Monday.

In the meantime, leading health officials are pleading with Americans to follow their recommendations and help arrest a pandemic that killed more than 36,000 people in November, pushing hospitalizations to a record high of nearly 93,000 on Sunday, according to a Reuters tally.

The widespread impact of the pandemic has led Merriam-Webster to choose “pandemic” as the Word of the Year after it racked up the most online dictionary lookups of any word.

“Sometimes a single word defines an era, and it’s fitting that in this exceptional – and exceptionally difficult – year, a single word came immediately to the fore,” the dictionary publisher said.

In the absence of a federal blueprint to curb the spread of the virus, states are issuing new or revamped restrictions on businesses and social life.

California’s governor said he may renew a stay-at-home order in the coming days, warning that ICU admissions are on track to exceed statewide capacity by mid-December unless public health policies and social behavior change.

“The red flags are flying,” Governor Gavin Newsom told reporters in an online briefing. “If these trends continue, we’re going to have to take much more dramatic, arguably drastic, action.”

(Reporting by Reuters staff; Writing by Daniel Trotta; Editing by Bernadette Baum)

Explainer-When and how will COVID-19 vaccines become available?

By Julie Steenhuysen and Carl O’Donnell

NEW YORK (Reuters) – Pfizer Inc with partner BioNTech SE and Moderna Inc have released trial data showing their COVID-19 vaccines to be about 95% effective at preventing the illness, while AstraZeneca Plc this week said its vaccine could be up to 90% effective.

If regulators approve any of the vaccines in coming weeks, the companies have said distribution could begin almost immediately with governments around the world to decide who gets them and in what order. The following is an outline of the process:

WHEN WILL COMPANIES ROLL OUT A VACCINE?

Pfizer, Moderna and AstraZeneca have already started manufacturing their vaccines. This year, Pfizer said it will have enough to inoculate 25 million people, Moderna will have enough for 10 million people and AstraZeneca will have enough for more than 100 million people.

The U.S. Department of Defense and the Centers for Disease Control and Prevention (CDC) will manage distribution in the United States, likely starting in mid-December with an initial release of 6.4 million doses nationwide.

UK health authorities plan to roll out an approved vaccine as quickly as possible, also expected in December.

In the European Union, it is up to each country in the 27-member bloc to start distributing vaccines to their populations.

WHO WOULD GET AN APPROVED VACCINE AND WHEN IN THE UNITED STATES?

Upon authorization from the U.S. Food and Drug Administration, the CDC has said first in line for vaccinations would be about 21 million healthcare workers and 3 million residents in long-term care facilities.

Essential workers, a group of 87 million people who do crucial work in jobs that cannot be done from home, are the likely next group. This includes firefighters, police, school employees, transportation workers, food and agriculture workers and food service employees.

Around 100 million adults with high-risk medical conditions and 53 million adults over the age of 65, also considered at higher risk of severe disease, are the next priority.

U.S. public health officials said vaccines will be generally available to most Americans in pharmacies, clinics and doctors offices starting in April so that anyone who wants a shot can have one by the end of June.

It is unclear when a vaccine will be available for children. Pfizer and BioNTech have started testing their vaccine in volunteers as young as 12.

WHEN WILL A VACCINE BE AVAILABLE IN OTHER COUNTRIES?

The European Union, the United Kingdom, Japan, Canada and Australia are all running rapid vaccine regulatory processes.

Many of AstraZeneca’s doses this year are expected to go to the United Kingdom, where health officials have said that if approved they could begin vaccinating people in December. At the top of their list is people living and working in care homes.

In Europe, the E.U. drugs regulator has said it could rule on the safety of a COVID-19 vaccine in December.

Most countries have said the first vaccines will go to the elderly and vulnerable and frontline workers like doctors.

Countries say they are buying vaccines via the European Commission’s joint procurement scheme, which has deals for six different vaccines and nearly 2 billion doses.

Delivery timelines vary and most countries are still drawing up plans for distributing and administering shots.

Italy expects to receive the first deliveries of the Pfizer-BioNTech shot and AstraZeneca’s shot early next year. Spain plans to give vaccines in January.

In Bulgaria, the country’s chief health inspector expects the first shipments in March-April. Hungary’s foreign minister said doses will land in the spring at the earliest.

Germany, home to BioNTech, expects to roll out shots in early 2021 with mass vaccination centers in exhibition halls, airport terminals and concert venues. It will also use mobile teams for care homes. Front-line healthcare workers and people at risk for serious COVID-19 are expected to get inoculated first.

WHEN WILL DEVELOPING COUNTRIES HAVE ACCESS TO VACCINES?

COVAX, a program led by the World Health Organization and the GAVI vaccine group to pool funds from wealthier countries and nonprofits to buy and distribute vaccines to dozens of poorer countries, has raised $2 billion.

Its first goal is to vaccinate 3% of the people in these countries with a final goal of reaching 20%. It has signed a provisional agreement to buy AstraZeneca’s vaccine, which does not require storage in specialized ultra cold equipment like the Pfizer vaccine.

It is expected but not certain that less wealthy countries in Africa and South East Asia, such as India, will receive vaccines at low or no cost under this program in 2021. Other countries such as those in Latin America may buy vaccines through COVAX. Several are also striking supply deals with drugmakers.

HOW MUCH WILL IT COST?

Vaccine makers and governments have negotiated varying prices, not all of which are public. Governments have paid from a few dollars per AstraZeneca shot to up to $50 for the two-dose Pfizer regimen. Many countries have said they will cover the cost of inoculating their residents.

(Reporting by Carl O’Donnell and Julie Steenhuysen; Additional reporting by Michael Erman in New York, Caroline Copley in Berlin, Francesco Gaurascio in Brussels, Josephine Mason in London, Krisztina Than in Budapest and Tsvetelia Tsolova in Sofia; Editing by Caroline Humer and Bill Berkrot)

Pfizer ends vaccine trial with 95% success rate, paving way for a shot this year

By Michael Erman and Ludwig Burger

(Reuters) – Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The efficacy of the shot was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately affected the elderly and certain groups including Black people.

The U.S. Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.

The success rate of the vaccine developed by U.S. firm Pfizer and Germany’s BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts said it was a significant achievement in the race to end the pandemic.

Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”

BioNTech’s Sahin said the U.S. emergency authorization would be applied for on Friday.

The FDA committee tentatively plans to meet on Dec. 8-10, a source familiar with the situation said, though the dates could still change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc <MRNA.O> released preliminary data for its vaccine on Monday, showing 94.5% effectiveness.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over 65 years, which experts said was crucial at a time when COVID-19 is running rampant around the world with record numbers of new cases and hospitalizations.

“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.

Global shares rose as the trial results countered concerns around the stubbornly high global infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. By contrast, Moderna dropped 4.2%.

Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.

DISTRIBUTING SHOTS

Pfizer says it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations this year, it will be months before large-scale rollouts begin in either country.

Pfizer also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Mike Ryan, the World Health Organization’s top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box.

Moderna’s vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F).

FATIGUE AND HEADACHES

Pfizer said its two-dose vaccine, called BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.

It said the only severe adverse events experienced by volunteers were fatigue and headaches. Out of 8,000 participants, 2% had headaches after the second dose while 3.8% experienced fatigue. Older adults tended to report fewer and milder adverse events.

“These are extraordinary results, and the safety data look good,” said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

“It would be interesting to see what adverse reactions were reported by the group getting the placebo, since that gives an idea of how much of the adverse effects are due to the vaccination process, and how much is due to the vaccine itself.”

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12. Moderna and Johnson & Johnson have said they hope to start testing the vaccine in younger patients soon.

(Reporting by Michael Erman in Maplewood, N.J.; Additional reporting by Ankur Banerjee in Bengaluru, Caroline Humer in New York, Dan Levine in San Francisco, Elizabeth Howcroft, Kate Kelland and Josephine Mason in London, Emilio Parodi in Milan and Stephanie Nebehay in Geneva; Writing by David Clarke; Editing by Pravin Char)

Explainer – Shot in the dark: Early COVID-19 vaccine efficacy explained

By John Miller

ZURICH (Reuters) – This week has seen a flurry of good news from COVID-19 vaccine developers, with Pfizer Inc. and BioNTech SE trumpeting early data indicating their mRNA candidate is more than 90% effective.

A Russian project came out a day later, touting 92% efficacy for the Sputnik V candidate, named after the Soviet-era satellite, based on a smaller data set.

HOW DO MANUFACTURERS ARRIVE AT EFFICACY NUMBERS?

In Pfizer’s case, it waited until 94 volunteers in its late-stage clinical trial of more than 43,500 people – half got the vaccine, the other half got a placebo – tested positive after developing symptoms.

For 90%-plus efficacy, no more than eight people among those who tested positive had received the vaccine, with the rest having received the placebo.

“Roughly speaking, it’s probably around eight to 86 cases in the treated and placebo groups,” David Spiegelhalter, a Cambridge professor of risk and an expert in statistics, told Reuters.

“You don’t need a lot of fancy statistical analysis to show that this is deeply impressive. It just hits you between the eyes.”

In Russia, Sputnik V-developer Gamaleya Institute reached its preliminary 92% efficacy figure based on 20 illnesses in 16,000 volunteers as its late-stage trial progresses. It aims to reach 40,000 people.

Of the 16,000 people, about quarter got the placebo.

“It suggests that there is some effect, but it’s insufficient to estimate the magnitude of it,” Spiegelhalter said.

HOW MANY PEOPLE MUST GET SICK IN BIG VACCINE TRIALS?

Some experts say that, ideally, 150 to 160 people in a trial of tens of thousands of participants must get sick before making a reliable assessment of a vaccine’s efficacy. That’s a bit of a rule of thumb, though, open to interpretation.

“There is no such regulatory standard requiring X number of events for making a reliable decision,” the government-funded Swiss Clinical Trial Organization said. “The amount of (infections) has to be seen in relation to the disease and its risk profile. It’s rather a case-by-case evaluation.”

Typically, regulators strive to have at least 95% certainty that the trial read-out is not the result of random variations with nothing to do with the tested compound.

For trial sponsors there is safety in numbers as a large enough trial can ensure that 95% reliability hurdle is cleared. But the larger the underlying clinical benefit, the fewer trial participants needed to create that clarity.

In Pfizer and BioNTech’s trial, they planned a final analysis when 164 people had become sick, with multiple, pre-planned interim analyses along the way. They skipped an analysis at 32 patients, and once they were ready to release a look at the 62-person mark, 94 had come down sick.

Details from the Russian trial are unclear, without access to its protocol.

HOW DO THESE RESULTS STACK UP TO OTHER DRUGS, OR VACCINES FOR OTHER ILLNESSES?

In normal drug trials, for diseases like terminal cancer, benefits of new medicines may be less apparent, with survival benefits of just a few months sometimes revolutionary for patients at death’s door.

For vaccines, however, marginal protection is inadequate, and the World Health Organization ideally wants to see at least 70% efficacy in trials, while the U.S. Food and Drug Administration wants at least 50%.

The 90% efficacy reported in the Pfizer and Russian trials beats those, and appears to exceed that of typical flu vaccines, which the U.S. Centers for Disease Control and Prevention (CDC) estimate reduce the risk of sickness by 40%-60%.

For other shots, the CDC estimates the efficacy of a two-shot measles vaccine at 97%, and a two-dose chicken pox vaccine at 90%. Two doses of polio vaccine are 90% effective, rising to nearly 100% with a third.

CAN WE EXPECT EFFICACY RATES TO HOLD UP AS TRIALS ADVANCE?

Pfizer acknowledged on Monday that its final vaccine efficacy percentage may vary. Still, Spiegelhalter said the study’s design seems likely to generally hold up, based on the 94 sick participants.

“In this case, the effect is so huge, even if there is a little bit of fallback – if the effects become slightly smaller over time – that is very unlikely to be significant.”

WHAT ABOUT REAL-WORLD EFFICACY, SHOULD THE VACCINES BE APPROVED?

The interim data is promising, since it appears to demonstrate that a vaccine can be effective in preventing COVID-19.

The jump to mass vaccinations, however, presents new hurdles, in particular for an mRNA vaccine like Pfizer and BioNTech’s that must be stored and shipped at minus 70 degrees Celsius (-94°F).

Moreover, the Pfizer-BioNTech vaccine requires two doses, ideally 21 days apart. If people do not stick to the timetable, it may affect the vaccine’s efficacy.

Protection against the mumps, for instance, drops from nearly 90% to 78%, if people don’t get a follow-up shot.

Swiss epidemiologist Marcel Tanner, president of Switzerland’s Academies of Arts and Sciences and one of the government’s top COVID-19 science advisers, expects possible variations in efficacy among older people, whose immune systems wane with time, or those with immune disorders.

“Efficacy says, ‘Does it work?’ Effectiveness says, ‘Can it be applied? Can you carry the efficacy to the people?'” Tanner said. “But no question: 90% efficacy, at that stage, is a pretty good result.”

(Reporting by John Miller in Zurich, Kate Kelland in London, Ankur Banerjee in Bengaluru, Julie Steenhuysen in Chicago and Polina Ivanova in Moscow; Editing by Josephine Mason and Nick Macfie)

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)