COVID-19 vaccine makers tell Congress U.S. supply will surge soon

By Michael Erman and Manojna Maddipatla

NEW YORK (Reuters) – COVID-19 vaccine makers told Congress on Tuesday that U.S. supplies should surge in the coming weeks due to manufacturing expansions and new vaccine authorizations.

Executives from Pfizer Inc, Moderna Inc and Johnson & Johnson – speaking at a hearing at the U.S. House of Representatives – said they would be able to supply enough vaccine to fully inoculate 130 million people in the United States by the end of March.

The drugmakers also reaffirmed their commitments to supply more than enough doses necessary to vaccinate all Americans by the end of July.

Pfizer Chief Business Officer John Young said it was plausible that there could be a surplus of vaccine in the United States sometime in the second quarter of this year.

“We certainly hope that we’re going to be in a position where every eligible adult will be able to receive vaccinations,” Young said.

Around 44.5 million people in the United States had received at least one dose of two-shot vaccines developed by Pfizer and BioNTech or Moderna, as of Tuesday morning.

Johnson & Johnson’s single-dose vaccine will be considered by an outside advisory committee to the U.S. Food and Drug Administration later this week, and emergency use authorization could come shortly afterward.

Richard Nettles, Vice President of Medical Affairs at J&J’s Janssen Pharmaceuticals unit, said the company would be able to ship nearly 4 million doses of its COVID-19 vaccine upon authorization and 20 million doses by the end of March.

Additional doses could also come from AstraZeneca Plc and from Novavax Inc, which are currently running clinical trials of their experimental vaccines.

An AstraZeneca executive said the drugmaker could supply doses necessary to vaccinate another 25 million people by the end of April if their vaccine is authorized by U.S. regulators.

(Reporting by Michael Erman; Editing by Bill Berkrot)

Drugmakers rush to test whether vaccines stop coronavirus variant

By John Miller and Patricia Weiss

ZURICH/FRANKFURT (Reuters) – Drug makers including BioNTech and Moderna are scrambling to test their COVID-19 vaccines against the new fast-spreading variant of the virus that is raging in Britain, the latest challenge in the breakneck race to curb the pandemic.

Ugur Sahin, chief executive of Germany’s BioNTech which with partner Pfizer took less than a year to get a vaccine approved, said on Tuesday he needs another two weeks to know if his shot can stop the mutant variant of the virus.

Moderna expects immunity from its vaccine to protect against the variant and is performing more tests in coming weeks to confirm, the company said in a statement to CNN. Moderna did not immediately respond to Reuters’ requests for comment.

The mutation known as the B.1.1.7 lineage may be up to 70% more infectious and more of a concern for children. It has sown chaos in Britain, prompting a wave of travel bans that are disrupting trade with Europe and threatening to further isolate the island country.

Sahin said there are nine mutations on the virus.

While he does not believe any are significant enough to skirt the protection afforded by BioNTech’s mRNA vaccine, which was approved by the European Union on Monday, he said another 14 days or so of study and data collection are needed before offering a definitive answer.

“Scientifically it is highly likely that the immune response by this vaccine can also deal with this virus variant,” he said on a call with reporters.

“The vaccine contains more than 1,270 amino acids, and only 9 of them are changed (in the mutant virus). That means that 99% of the protein is still the same.”

Germany’s CureVac said it does not expect the variant to affect the efficacy of its experimental shot, which is based on the same messenger RNA (mRNA) technology used by Pfizer-BioNTech.

It started late stage clinical trials on its vaccine candidate last week and is constantly reviewing variants, which the company said are common as viruses spread.

Even though there are multiple mutations, BioNTech’s Sahin said, most of the sites on the virus that are recognized by the body’s T-cell response are unchanged, and multiple antibody binding sites are also conserved.

MRNA ADVANTAGE

In the event that the variant presents vaccine developers with an unexpected challenge, an advantage of mRNA is that scientists can quickly re-engineer genetic material in the shot to match that of the mutated protein, whereas modifying traditional vaccines would require extra steps.

“In principle, the beauty of the mRNA technology is we can directly start to engineer a vaccine which completely mimics this new mutation,” Sahin said.

“We could be able to provide a new vaccine technically within six weeks. Of course, this is not only a technical question. We have to deal with how regulators… would see that.”

Britain’s chief scientific adviser Patrick Vallance said on Saturday vaccines appeared to be adequate in generating an immune response to the variant of the coronavirus.

The World Health Organization (WHO) said on Tuesday it will convene a meeting of members to discuss strategies to counter the mutation.

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

By Alistair Smout

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

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

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

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

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

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

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

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

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

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

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

FIVE DAYS IN A FRIDGE

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

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

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

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

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

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

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

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

A SHOT FOR SHAKESPEARE

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

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

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

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

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

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

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

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

By Julie Steenhuysen and Michael Erman

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

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

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

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

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

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

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

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

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

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

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

‘JUST OVERWHELMING’

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

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

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

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

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

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

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

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

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

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

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

CONSISTENT ACROSS AGE AND ETHNICITY

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

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

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

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

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

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

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

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

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

Breakthrough COVID vaccine tech could help defeat other diseases

By John Miller and Ludwig Burger

ZURICH/FRANKFURT (Reuters) – Breakthrough technology that transforms the body into a virus-zapping vaccine factory is poised to revolutionize the fight against COVID-19 but future pandemics and even cancer could be next, scientists say. The initial success of so-called messenger ribonucleic acid (mRNA) vaccines in late-stage trials by Moderna as well as Pfizer and its German partner BioNTech is the first proof the concept works.

Both experimental vaccines had efficacy rates above 90% based on interim findings, which was far higher than expected and well above the 50% threshold U.S. regulators insist upon for vaccines.

Now scientists say the technology, a slow-motion revolution in the making since the discovery of mRNA nearly 60 years ago, could speed up the development of new vaccines.

The traditional method of creating vaccines – introducing a weakened or dead virus, or a piece of one, to stimulate the body’s immune system – takes over a decade on average, according to a 2013 study. One pandemic flu vaccine took over eight years while a hepatitis B vaccine was nearly 18 years in the making.

Moderna’s vaccine went from gene sequencing to the first human injection in 63 days.

With BioNTech and Pfizer’s COVID-19 candidate on a similar trajectory, both could win regulatory approval this year, barely 12 months since the coronavirus first emerged.

Other companies are pursuing the technology such as Germany’s CureVac also has an mRNA vaccine candidate, though has yet to start a late-stage trial and is hoping it will get the green light after July 2021. “We’ll look back on the advances made in 2020 and say: ‘That was a moment when science really did make a leap forward’,” said Jeremy Farrar, director of the Oxford University Clinical Research Unit, which is backed by the Wellcome Trust.

THE LAST LAUGH

Discovered in 1961, mRNA carries messages from the body’s DNA to its cells, telling them to make the proteins needed for critical functions, such as coordinating biological processes like digestion or fighting disease.

The experimental vaccines from Moderna as well as Pfizer and BioNTech use lab-made mRNA to instruct cells to make the coronavirus’s spike proteins, which spur the immune system into action without replicating like the actual virus. Back in 1990, scientists managed to get mice to generate proteins by injecting mRNA, an early sign of the technology’s potential.

But early proponents such as Katalin Kariko, a Hungarian-born scientist and senior vice president at BioNTech, were hampered by obstacles such as mRNA’s instability in the body and its propensity to cause inflammatory responses.

A breakthrough came around 2005 when Kariko, along with colleagues at the University of Pennsylvania, figured out how to deliver mRNA without kicking the immune system into overdrive.

Still, it took another 15 years – and a pandemic that brought the world’s economy to its knees – to reach the cusp of success. Kariko said her years of dogged pursuit once made her the butt of jokes for some university colleagues.

“The last time they laughed at me and ridiculed me was when they learned that I was going to join BioNTech seven years ago and they realized this company (didn’t) even have a website,” she told Reuters. “But now, they learn of BioNTech and that we can do good things.”

Kariko said her life’s work could pay dividends, not just against COVID-19, but other diseases.

“It could be easier sailing for the next anti-viral product, a vaccine for influenza and other infectious disease,” said Kariko, whose daughter is a U.S. Olympic gold medalist rower.

CANCER NEXT?

Moderna and BioNTech, for example, are also applying mRNA technology to experimental cancer medicines.

BioNTech is testing an anti-melanoma mRNA with Swiss pharmaceutical giant Roche in a Phase II trial.

Among Moderna’s most advanced projects, besides its COVID-19 vaccine, are mRNA compounds to treat ovarian cancer or Myocardial ischemia, which are also in the second test phase.

None of the potential mRNA cancer therapies have reached the critical large-scale Phase III trials, however, and Kariko acknowledges that cancer presents a bigger challenge.

While a virus is a foreign intruder, cancer cells, however malignant, come from within the body, making them tougher to seek out and expose so they can be attacked.

“Sometimes cancer is just caused by gene and chromosome duplication and then everything about it looks normal and the cell is just dividing more than it should,” she said.

For vaccines against infectious diseases, the pharmaceutical industry’s traditional approach has been to whip them up in large bioreactors, a time-consuming, expensive process in facilities that can cost up to $700 million to build.

By contrast, Zoltan Kis, an Imperial College London researcher who models vaccine manufacturing, estimates that one five-liter bioreactor inside a $20 million facility could make a billion doses of some kinds of mRNA vaccines a year.

Drug manufacturer Lonza, enlisted to make ingredients for 400 million doses of Moderna’s vaccine annually at U.S. and Swiss sites, is due to start production this year with manufacturing lines costing $60 million to $70 million each.

“We are producing mRNA at smaller scales and in smaller facilities when compared to traditional larger-scale equipment and facilities,” Andre Goerke, Lonza’s global lead for the Moderna project, told Reuters. “The manufacturing ramp-up is quicker and more economical.”

‘ULTRA-FAST RESPONSE’

Raymond Schiffelers, of University Medical Center Utrecht in the Netherlands, who heads a European Union program for mRNA therapeutics, said the major advantage of the technology was that vaccine developers could mount an “ultra-fast response”.

“Within weeks, testing can start, a major advantage over conventional vaccines,” he said.

The moment a pathogen’s genomic sequence is known, synthetic mRNAs can be designed that encode key parts of the virus, such as the coronavirus’s potentially lethal spike protein.

Risks and challenges for mRNA remain.

Some candidates must be stored at extremely cold temperatures, making delivery potentially difficult in countries with limited infrastructure. They also may be fragile to transport, Schiffelers said.

BioNTech’s vaccine, for example, must be transported at minus 70 degrees Celsius, though Moderna said on Monday it can ship its candidate in normal refrigerators.

Francis Collins, director of the U.S. National Institutes of Health (NIH), which funded Moderna’s vaccine development, also said mRNA vaccines may not be a silver bullet for flu, since it mutates so swiftly that reaching 90% efficacy is unlikely.

But for COVID-19, Collins said mRNA is likely to be a revolution.

“It’s clearly several months faster than any of the other methods,” Collins said. “In a crisis moment, several months really matter.”

(Reporting by John Miller in Zurich, Allison Martell in Toronto, Ludwig Burger in Frankfurt, Kate Kelland in London, Michael Erman in New York, Julie Steenhuysen in Chicago and Marton Dunai in Budapest; Editing by Josephine Mason and David Clarke)

Russia says its Sputnik V COVID-19 vaccine is 92% effective

By Polina Ivanova

MOSCOW (Reuters) – Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with Western drugmakers in the race for a shot.

Russia’s results are only the second from a late-stage human trial, following on swiftly from data released on Monday by Pfizer Inc. and BioNTech, which said their shot was also more than 90% effective.

While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19.

The analysis was conducted after 20 participants developed the virus and examined how many had received the vaccine versus a placebo. That is significantly lower than the 94 infections in the trial of the vaccine being developed by Pfizer and BioNTech.

“I assume there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the Mainz University. “What is missing for now is an analysis of statistical significance.”

To confirm the efficacy rate of its vaccine, Pfizer said it would continue its trial until there were 164 COVID-19 cases.

The Russian Direct Investment Fund (RDIF), which has been backing Sputnik V’s development, said the Russian trial would continue for six months.

Alexander Gintsburg, director of the Gamaleya Institute which developed the vaccine, said the interim results demonstrated that Sputnik V was effective and mass vaccinations would be rolled out in Russia in the coming weeks.

European stocks and U.S. stock futures extended their gains slightly after Russia’s announcement though the reaction was far more muted than after Pfizer’s results.

China’s Sinopharm, which is running large-scale late-stage clinical trials for two COVID-19 vaccine candidates, said on Wednesday that its data was better than expected, though it did not give further details.

‘NOT A COMPETITION’

Successful vaccines are seen as crucial to restoring daily life around the world by helping end the pandemic that has killed more than 1.26 million people, shuttered businesses and put millions out of work.

However, experts said knowledge about the Russian trial’s design was sparse, making it hard to interpret the data.

Scientists have raised concerns about the speed at which Moscow has worked, giving the regulatory go-ahead for the shot and launching mass vaccinations before full trials to test its safety and efficacy had been completed.

“This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for un-blinding the trial data are adhered to avoid cherry picking the data,” said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh.

“Anything less than this risks a public loss of trust in all vaccines, which would be a disaster.”

The results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine.

“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.

The so-called Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.

The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said.

That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.

The RDIF said data from the study would be published in a leading medical journal following a peer review. The results of the early-stage Russian trials were peer reviewed and published in September in The Lancet medical journal.

Experts said that as with the Pfizer results, it was not yet clear how long immunity would last after taking the Russian vaccine, nor how efficient it would be for different age groups.

“We certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer’s and BioNTech’s numbers,” said Plachter in Mainz.

As Moscow seeks partners abroad to boost output, China’s Tibet Rhodiola Pharmaceutical Holding announced a deal soon after the results to released to make, sell and test the shot in China.

SPUTNIK V

The Russian drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Russian President Vladimir Putin.

Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September.

So far, it has inoculated 10,000 members of the public considered at high risk of contracting COVID-19 such as doctors and teachers, outside of the trial.

The vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.

Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.

RDIF said as of Nov. 11 no serious side effects had been reported during the Sputnik V Phase III trial.

Some volunteers had short-term minor adverse events such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache, it said.

In late October, the vaccination of new volunteers was temporarily paused due to high demand and a shortage of doses.

Russia’s deputy prime minister said on Wednesday that the Vector Institute vaccine was expected to start post-registration trials on Nov. 15.

She also said that Russia would produce 500,000 doses of Sputnik V in November, lower than a previous forecast of 800,000 doses given by Trade and Industry Minister Denis Manturov.

Russia reported 19,851 new coronavirus infections in the past 24 hours and a record high of 432 deaths. At 1,836,960, its overall case tally is the fifth largest in the world, behind the United States, India, Brazil and France.

(Reporting by Polina Ivanova; Additional reporting by Kate Kelland, Ludwig Burger, Josephine Mason and Thyagaraju Adinarayan; Editing by David Clarke)

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)

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)

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., 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)