Tag Archives: Moderna

Moderna says possible allergic reactions to COVID-19 vaccine under investigation

(Reuters) – Moderna Inc said on Tuesday it had received a report from California’s health department that several people at a center in San Diego were treated for possible allergic reactions to its COVID-19 vaccine from a particular batch.

The company’s comments come after California’s top epidemiologist on Sunday issued a statement recommending providers pause vaccination from lot no. 41L20A due to possible allergic reactions that are under investigation.

“A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours,” the epidemiologist said in a statement.

The vaccine maker said it was unaware of comparable cases of adverse events from other vaccination centers which may have administered vaccines from the same lot or from other lots of its vaccine.

A total of 307,300 doses from the lot remain in storage, Moderna said, of the total 1,272,200 doses that were produced in the batch.

Moderna said it was working closely with U.S. health regulators to understand the cases and whether pausing the use of the lot was warranted.

Nearly a million doses from the lot have already been distributed to about 1,700 vaccination sites in 37 states, Moderna said.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Vinay Dwivedi and Shinjini Ganguli)

Moderna raises 2021 vaccine output forecast to at least 600 million doses

(Reuters) – Moderna Inc said on Monday it would produce at least 600 million doses of its COVID-19 vaccine in 2021, up by 100 million doses from its previous forecast, as the United States continues to roll-out the vaccine.

The company was working to invest and hire in order to deliver up to 1 billion doses this, the higher end of its production forecast, it said.

Moderna said it has so far supplied about 18 million doses to the U.S. government as part of a deal for 200 million doses. It has also signed a deal with the Canadian government for 40 million doses.

(Reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur)

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.

Moderna’s coronavirus vaccine faces U.S. FDA expert panel review

(Reuters) – A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine.

The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come some time after 3 pm ET (2000 GMT), with an FDA authorization expected as soon as Friday.

This is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later.

That vaccine is being distributed throughout the country. A massive inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot, making it a better option for remote and rural areas. Both vaccines were about 95% effective in preventing illness in pivotal clinical trials.

The FDA advisory committee is likely to discuss Moderna’s reports of side effects from its 30,000-person trial, which were more frequent than those reported by Pfizer. These were primarily relatively short-lived reactions to the vaccination rather than serious adverse events.

SVB Leerink analysts said the Moderna vaccine appears less tolerable than the Pfizer/BioNTech shot, but noted that is not a proper comparison across trials and unlikely to stand in the way of an EUA.

The FDA staff did not raise any serious concerns about safety in documents published on Tuesday in preparation for the meeting. It said a link between Bell’s palsy, which causes temporary paralysis of facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.

Pfizer and BioNTech said those cases occurred at the same rate as in the general population.

Moderna is seeking authorization for people aged 18 and older. That could sidestep the lively discussion last week among panel members about whether there was enough data to authorize use of the Pfizer/BioNTech vaccine in adolescents aged 16 and 17. They ultimately voted to back that vaccine for those 16 and older.

Initial Moderna vaccine supply would likely go to the United States, which has signed deals to secure as many as 200 million doses and is expecting the first 20 million this month. The vaccine is administered in two doses about four weeks apart.

The company has also signed supply deals with Canada, the European Union and the UK. The vaccine is undergoing a “rolling review” by regulators for all three.

(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

Moderna to supply four million more doses of COVID-19 vaccine to Israel

(Reuters) – Moderna Inc said on Friday it has extended its contract with the Israeli health ministry to supply an additional 4 million doses of its COVID-19 vaccine candidate.

Israel has now secured access to 6 million doses of Moderna’s mRNA-1273, currently under review in the country.

Financial terms and delivery timelines related to the deal were not disclosed.

In June, Israel signed an agreement with Moderna for its vaccine to protect its people from the new coronavirus. The country, with a population of 9 million, has reported 339,942 cases and 2,890 deaths, according to a Reuters tally.

It has also reached an understanding with AstraZeneca Plc to receive about 10 million doses of its experimental COVID-19 vaccine.

Moderna said it continues to scale up its global manufacturing to boost delivery by about 500 million doses per year, and possibly up to 1 billion doses a year, beginning 2021.

The company has submitted applications seeking emergency use authorization in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective with no serious safety concerns.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

AstraZeneca vaccine can be up to 90% effective; COVID-19 reinfection unlikely for at least six months

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

AstraZeneca COVID-19 vaccine shows up to 90% efficacy

An interim analysis of late-stage trials of AstraZeneca’s COVID-19 vaccine finds it prevented 70% of COVID-19 cases with no confirmed serious adverse effects, the company announced on Monday. In 8,895 participants who got two full doses, the efficacy was 62%. But due to a dosing error that proved to be a happy accident, among 2,741 volunteers who got a half dose followed by a full dose, efficacy rose to 90%. Pfizer and Moderna reported that their vaccines were about 95% effective at preventing illness. But AstraZeneca’s vaccine is cheaper, easier to make, and can be stored at normal refrigerator temperatures. Investment analysts at SVB Leerink said Astra’s vaccine was unlikely to gain U.S. approval because safety data so far are inadequate and the trial design did not meet U.S. requirements for representation of high-risk groups such as the elderly and minorities. AstraZeneca said it plans to seek approval to modify its U.S. study to get more data on the smaller initial dose. Eventually, all three vaccines could prove comparable. “My suspicion is that by the time we are a year down the line, we’ll be using all three vaccines with about 90% protection,” said immunologist Danny Altmann of Imperial College London.

COVID-19 reinfection appears unlikely for at least 6 months

People who have had COVID-19 are unlikely to contract it again for at least six months, British researchers said on Thursday in a report posted on medRxiv ahead of peer review. Between April and November, they tracked more than 12,000 frontline healthcare workers at high risk for infection with the new coronavirus. COVID-19 with symptoms occurred in 89 of 11,052 workers who did not already have antibodies showing exposure to the virus, whereas none of the 1,246 staff with antibodies developed a recurrent infection. Staff with antibodies were also less likely to test positive for COVID-19 without symptoms, the researchers said. “This is really good news because we can be confident that, at least in the short term, most people who get COVID-19 won’t get it again,” said coauthor David Eyre of Oxford’s Nuffield Department of Population Health. Maria van Kerkhove of the World Health Organization added, “We still need to follow these individuals for a longer period of time to see how long immunity lasts.”

Delirium may signal COVID-19 in elderly

Delirium is common among older patients with COVID-19 and may be their only symptom, U.S. researchers warned on Thursday in JAMA Network Open. Among more than 800 COVID-19 patients over age 65 who showed up at emergency departments around the country, nearly 30% had delirium, they found. Overall, delirium was the sixth most common of all the symptoms and signs in these older patients. Those most at risk for delirium included elders with vision or hearing impairment, stroke, Parkinson’s disease and residents of assisted living or skilled nursing facilities. Delirium is not on any official list of COVID-19 signs and symptoms, but the U.S. Centers for Disease Control and Prevention (CDC) should add it, said coauthor Dr. Maura Kennedy of Massachusetts General Hospital in Boston. “Sometimes delirium is the chief complaint when these patients arrive at the emergency department,” Kennedy said. “But there can be a number of reasons they come, including falls that occurred because of the delirium. They may present without what we consider typical COVID-19 symptoms, such as fever, shortness of breath and cough.”

New data help distinguish COVID-19 from flu

Certain findings can help distinguish COVID-19 from influenza or other respiratory illnesses, a new study suggests. Israeli doctors studied 693 hospitalized patients with COVID-19, plus more than 8,000 adults who had been hospitalized in previous years for the flu or severe respiratory infections. Compared to the other patients, those with COVID-19 were on average younger, more overweight, and had fewer preexisting conditions other than dementia, which was more prevalent in COVID-19 patients. Upon hospital admission, COVID-19 patients had overall lower levels of infection-fighting white blood cells and neutrophils, but their hearts were beating faster, they had less oxygen in their blood, and they had higher percentages of immune-system B cells, which produce antibodies to attack invading germs, and T cells, which destroy cells that have become infected. During the first two days of hospitalization, white blood cell and neutrophil levels rose in COVID-19 patients but fell in the other groups, the researchers said in a paper posted on Sunday on medRxiv ahead of peer review. “At the dawn of winter, recognizing the characteristics discriminating COVID-19 from influenza, will be critical to support the management of the current pandemic,” they conclude.

(Reporting by Nancy Lapid, Linda Carroll, Kate Holton, Josephine Mason and Kate Kelland; Editing by Bill Berkrot)

AstraZeneca COVID-19 vaccine shows promise in elderly, trial results by Christmas

By Kate Kelland and Alistair Smout

LONDON (Reuters) – AstraZeneca and Oxford University’s potential COVID-19 vaccine produced a strong immune response in older adults, data published on Thursday showed, with researchers expecting to release late-stage trial results by Christmas.

The data, reported in part last month but published in full in The Lancet medical journal on Thursday, suggest that those aged over 70, who are at higher risk of serious illness and death from COVID-19, could build robust immunity.

“The robust antibody and T-cell responses seen in older people in our study are encouraging,” said Maheshi Ramasamy, a consultant and co-lead investigator at the Oxford Vaccine Group.

“We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

Late-stage, or Phase III, trials are ongoing to confirm the findings, researchers said, and to test whether the vaccine protects against infection with SARS-CoV-2 in a broad range of people, including people with underlying health conditions.

Results of those trials should definitely be known by Christmas, the Oxford Vaccine Group’s director, Andrew Pollard, said, adding it was too early to know whether and how well the vaccine works in preventing COVID-19 disease.

“We’re still waiting to get to the point where we can do the analysis to just work out how well the vaccine can protect people, and we’re getting ever closer to that,” he told journalists.

“We are optimistic that we’ll be able to do that before Christmas, and obviously we’ll share that with you as soon as we can at that point.”

The Oxford-AstraZeneca COVID-19 vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, had been among the front-runners in global efforts to develop shots to protect against infection with the novel coronavirus, or SARS-CoV-2.

But rival drugmakers Pfizer Inc, BioNTech and Moderna Inc have in the past 10 days edged ahead, releasing data from late-stage COVID-19 vaccine trials that shows more than 90% efficacy.

“We’re not in a rush. We and it’s not a competition with the other developers,” Oxford’s Pollard said, adding that AstraZeneca would release headline efficacy data before it was published in an academic journal.

Oxford University has set a target of 53 infections to start the interim analysis of its late-stage trial results, though “lots of cases” in its trial arms in Britain, South Africa and Brazil mean the exact number of infections reported could differ.

Unlike the Pfizer-BioNTech and Moderna shots, both of which use new technology known as messenger RNA (mRNA), AstraZeneca’s is a viral vector vaccine made from a weakened version of a common cold virus found in chimpanzees.

The Phase II trial reported in The Lancet involved a total of 560 healthy volunteers, with 160 aged 18-55, 160 aged 56-69, and 240 aged 70 or over.

Volunteers got two doses of the vaccine or a placebo, and no serious side effects related to the AZD1222 vaccine were reported, the researchers said.

AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.

(Reporting by Kate Kelland; Additional reporting by Alistair Smout; Editing by Matthew Lewis, Alexander Smith and Nick Macfie)

Air France-KLM prepares COVID-19 vaccine airlift

PARIS (Reuters) – Air France-KLM is among airlines gearing up for the challenge of transporting millions of doses of temperature-sensitive COVID-19 vaccines in the midst of a travel slump.

Breakthrough vaccines developed by Pfizer and Moderna have yet to win final approval, but the drugmakers, their logistics and cargo providers are not waiting for a green light to activate freight plans.

Air France-KLM, which has decades of experience shipping medicines and vaccines in temperature-controlled conditions, is preparing a test run in coming days to fly out dummy vaccine shipments from KLM’s Amsterdam-Schiphol hub.

The task is complicated by the conditions required by the Pfizer and Moderna shots – with respective storage temperatures of minus 80 Celsius and minus 20C.

“It’s going to be a major logistics challenge,” said Air France cargo chief Christophe Boucher, citing the “massive” volume of vaccines to be distributed globally.

“Another difficulty is the temperature control,” Boucher said in an interview at Paris-Charles de Gaulle airport – where cargo specialists were preparing to load consignments of super-cooled rabies vaccines bound for Brazil.

The COVID-19 airlift is being planned amid a partial shutdown of global air travel. Airlines have warned that travel curbs could hamper the effort, since around 45% of global cargo typically travels in passenger plane holds.

Air France-KLM does not rule out bringing idled jets back into service for the vaccine shipments, pharma cargo manager Florent Gand said. “We have some planes currently grounded that we can use if necessary to transport the COVID-19 vaccines around the world.”

(Reporting by Noemie Olive and Laurence Frost; Editing by Mark Potter)

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)

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)