Moderna targets 1 billion more COVID vaccine doses for poor countries

Moderna Inc said on Friday it aims to deliver one billion doses of its COVID-19 vaccine to low-income countries in 2022, in addition to the doses it has already committed to the global vaccine-sharing platform COVAX.

These vaccines will be part of the 2-3 billion doses the company had forecast to produce next year.

"To date, more than 250 million people have been vaccinated globally with the Moderna COVID-19 vaccine. However, we recognize that access to vaccines continues to be a challenge in many parts of the world," Chief Executive Officer Stéphane Bancel said in a letter posted on the company's website.

Moderna on Thursday announced plans to invest up to $500 million to build a factory in Africa to make up to 500 million doses of mRNA vaccines each year, including its COVID-19 shot.

The company had committed in May to supply up to 500 million doses of its COVID-19 vaccine to the COVAX facility from the fourth quarter of 2021 through 2022.

"We are committed to doubling our manufacturing and expanding supply even further until our vaccine is no longer needed in low-income countries," Bancel said.

-reuters-

Pfizer, Moderna vaccines effective against Indian variants: study

WASHINGTON - The Pfizer and Moderna COVID vaccines should remain highly effective against two coronavirus variants first identified in India, according to new research carried out by US scientists.

The lab-based study was carried out by the NYU Grossman School of Medicine and NYU Langone Center and is considered preliminary because it has not yet been published in a peer-reviewed journal.

"What we found is that the vaccine's antibodies are a little bit weaker against the variants, but not enough that we think it would have much of an effect on the protective ability of the vaccines," senior author Nathaniel "Ned" Landau told AFP on Monday.

The researchers first took blood from people who were vaccinated with either of the two shots, which are predominant in the United States and have been given to more than 150 million Americans.

They then exposed these samples in a lab to engineered pseudovirus particles that contained mutations in the "spike" region of the coronavirus, which were particular to either the B.1.617 or B.1.618 variants, first found in India.

Finally, that mixture was exposed to lab-grown cells, to see how many would become infected.

The engineered pseudovirus particles contained an enzyme called luciferase, which fireflies use to light up. Adding it to the pseudovirus makes it possible to tell how many cells are infected, based on light measurements.

Overall, for B.1.617 they found an almost four-fold reduction in the amount of neutralizing antibodies -- Y-shaped proteins the immune system creates to stop pathogens from invading cells. For B.1.618, the reduction was around three-fold.

"In other words, some of the antibodies now don't work anymore against the variants, but you still have a lot of antibodies that do work against the variants," said Landau.

"There's enough that do work that we believe that the vaccines will be highly protective," he added, because the overall levels remain well above those found in samples taken from people who recovered from infection with earlier unmutated virus.

But this kind of lab investigation cannot predict what the real world efficacy might look like -- that will have to be investigated through other studies.

The coronavirus is known to latch on to a particular receptor on human cells called ACE2, which it uses to force its entry.

Landau's team showed the Indian variants were able to bind more tightly to this receptor, like other variants of concern. This might be linked to its increased transmissibility compared to the original strain.

"Our results lend confidence that current vaccines will provide protection against variants identified to date," the team concluded. 

However, they do not preclude the possibility that newer variants that are more resistant to vaccines will emerge -- highlighting the importance of widespread vaccination at the global level.

Agence France-Presse

Moderna COVID vaccine efficacy falls slightly to 90 percent in US trial

WASHINGTON - US biotech company Moderna announced Covid vaccine is 90 percent effective against all forms of the disease and 95 percent effective against severe disease.

The new results come from its ongoing Phase 3 clinical trial involving more 30,000 people across the United States, and the headline efficacy figure is a slight decrease from an earlier figure of 94.1 percent published in the New England Journal of Medicine in December. 

The new number is based on 900 adjudicated cases of Covid from the study as of April 9, while the previous was based on 185 cases.

A company press release did not indicate why efficacy has fallen, but one reason might be the emergence of new variants of concern which are not as susceptible to antibodies evoked to the vaccine.

Moderna is working on two variant-specific boosters, and said mice studies showed they elicited an increased immune response. The results of these studies have been posted online in a scientific paper that is now awaiting peer review.

"The new preclinical data on our variant-specific vaccine candidates give us confidence that we can proactively address emerging variants," said CEO Stephane Bancel.

The company said that as of April 12, it has delivered 132 million doses of its vaccine globally, including approximately 117 million doses to the United States.

It remains on course to deliver its second tranche of 100 million doses by the end of May followed by 100 million more by the end of July.

The company's clinical trial for adolescents aged 12 to 17 is now fully enrolled with 3,000 US participants, and its pediatric trial for children aged six months to 11 years is continuing to enroll its 6,750 participants in the United States and China.

Agence France-Presse

Indonesia orders 20 million COVID-19 vaccine doses for private inoculations

JAKARTA - Indonesia expects to receive 20.2 million doses of COVID-19 vaccines developed by Moderna Inc and China's Sinopharm from the second quarter to use in a private vaccination scheme, the head of a state pharmaceutical firm said on Monday.

Indonesia authorized one of the world's first private vaccination programs last month to run alongside its national drive, enabling firms to buy state-procured vaccines for their staff in Southeast Asia's biggest country.

While the plan is expected to speed up the pace of inoculation in the world's fourth most populous country, some health experts have warned it could worsen inequity.

Honesti Basyir, CEO of Bio Farma, told a parliamentary hearing on Monday that it had ordered 15 million doses from China National Pharmaceutical Group (Sinopharm) and 5.2 million from Moderna.

The Sinopharm vaccine could arrive by the end of the second quarter, and the Moderna shot in the third quarter, he said.

Indonesia aims to inoculate 181.5 million people within a year in an effort to reach herd immunity in a vaccination drive that began in January.

The country has suffered one of Asia's worst coronavirus epidemics, with more than 1.4 million cases and over 38,000 deaths so far.

The Indonesian Chamber of Commerce and Industry had pushed the government to authorize the private inoculation drive.

More than 11,500 companies have signed up for the plan, which would see some 7.4 million people vaccinated, Rosan P. Roeslani, head of the business group, told the same hearing on Monday.

The program would allow employees of participating companies, plus their family members, to receive free vaccinations at privately-run health centers with shots distributed by Bio Farma.

Indonesia's food and drug agency is currently reviewing the Sinopharm vaccine for emergency use approval, its chief Penny K. Lukito told the hearing.

The agency has made no mention of the approval status of the Moderna vaccine.

-reuters-

EU drugs regulator plans to fast track variant-modified COVID vaccines

MILAN, Italy - Europe's medicines regulator is planning to speed up assessments of any COVID-19 vaccines that are modified to protect against variants of the virus, the head of the agency's COVID-19 task-force told Reuters on Friday.

Marco Cavaleri, chair of the vaccine evaluation team at the European Medicines Agency (EMA), said there should be no need for lengthy large-scale trials like those needed to evaluate the first COVID-19 vaccines, since tweaks for new variants can be tested on smaller groups.

"We are working on updated guidelines, assuming that we cannot ask for large Phase III trials. This will allow us to go faster," said Cavaleri.

"We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000," he told Reuters. He said the EMA would focus primarily on immune response data.

Drugmakers including Pfizer, Moderna and AstraZeneca have been testing their COVID-19 vaccines against several fast-spreading, more infectious variants of the novel coronavirus.

Variants which emerged in Brazil (known as P.1.), Britain (known as 20I/501Y.V1 or B.1.1.7) and South Africa (known as 20I/501Y.V2 or B.1.351) have already spread around the world, piling more pressure on governments struggling to tame the pandemic which has killed almost 2.5 million people.

These are the three major variants that are worrying scientists, with their spread raising the risk that newly-developed COVID-19 vaccines will need to be updated or tweaked to be effective against some variants, and that people may require one or more booster shots.

STREAMLINING

Last week, the U.S. Food and Drug Administration also said it is considering a rapid review process for the quick turnaround of new COVID-19 booster shots if variants emerge against which the vaccines do not provide protection.

Vaccine makers Pfizer and BioNTech, as well as AstraZeneca and Moderna, whose COVID shots have been authorised for emergency use in Europe, have said they are preparing for the possibility that variants will emerge that could require tweaks to their vaccines.

Normally, an EMA approval requires extensive studies with large numbers, starting with safety and ending with efficacy.

"We will also try to streamline regulatory procedures doing something similar to what happens with flu vaccines. In short, without the drugmakers having to submit all the preliminary data again", Cavaleri said.

He added that the EMA is also aware that in the near future it may no longer be possible to do clinical trials with placebo for categories such as the elderly, due to rollout of current COVID-19 vaccines.

"In that case we could think about a head-to-head comparison with an already approved vaccine", he said.

Cavaleri also told Reuters Johnson & Johnson will file its vaccine formal application in the next few days.

"Probably as early as next week", he said, noting that the EMA has been conducting a rolling review of the vaccine for some time. "Mid-March is reasonable for the EMA decision," he said.

The EMA, he added, has been in contact to date with about 50 pharmaceutical companies working on COVID vaccines.

Regarding the Russia's Sputnik V vaccine, he said the agency is in constant contact with the company producing it.

"There is a constructive cooperation. If there are no problems with the answers we receive on the subject of the production phase, the rolling review could start within a matter of weeks," he said

The EMA is also in contact with the Chinese companies developing vaccines, particularly Sinovac Biotech, but the process for the Chinese vaccine is a few steps behind the Russian one, he said. 

(Reporting by Emilio Parodi, editing by Kate Kelland and Kirsten Donovan)

-reuters-

Moderna vaccine results 'stunningly impressive,' Fauci tells AFP

WASHINGTON - The United States' top infectious disease official on Monday hailed early results from Moderna's COVID-19 vaccine as "stunningly impressive," calling the result a validation for experimental mRNA technology that some had doubted.

"I had said, and I must admit, that I would have been satisfied with 70, or at the most 75 percent efficacy," Anthony Fauci told AFP.

"The idea that we have a 94.5 percent effective vaccine is stunningly impressive. It is really a spectacular result that I don't think anybody had anticipated would be this good."

The physician-scientist leads the National Institutes of Health's National Institutes of Allergies and Infectious Diseases (NIAID), which began co-developing the vaccine in January, shortly after Chinese authorities disclosed the genetic sequence of the new coronavirus.

The vaccine is based on a new technology that uses a synthetic version of a molecule called "messenger RNA" to hack into human cells, and effectively turn them into vaccine-making factories.

"There were many people who had reservations about using something that had not been tried and true over the years, in fact some people even criticized us for that."

On Monday, Moderna and the NIH announced their preliminary results based on 95 of the 30,000 volunteers they have recruited who fell ill with COVID-19.

Of the 95, 90 had been in the trial's placebo group, and 5 in the group that received the drug, called mRNA-1273, translating to an efficacy rate of 94.5 percent.

Asked whether it was too early to say if the mRNA platform had now been proven, Fauci, who is usually known for his cautious statements, said the jury was in.

"Oh no! I think when you have 2 vaccines, like this, that have proven to be greater than 90 percent effective, I think that mRNA is here, it's established itself, it doesn't need to prove anything anymore.

"The data speak for themself, it isn't me, it isn't my opinion, look at the data."

While Moderna has basked in the spotlight, Fauci was keen to highlight the critical work of the NIH, which he said was responsible for developing the correct "conformation" or spatial arrangement of the virus' spike protein, which the vaccine makes inside the body to elicit an immune response.

Looking forward, he said he was worried about anti-vaccine sentiment in the United States, the hardest-hit country in the world. 

"There's a long way to go -- don't forget, you've got to get this distributed, you've got to get most of the people to get vaccinated.

"There's a lot of anti-vaccine sentiment in this country. You've got to overcome that and convince people to get vaccinated because a vaccine with a high degree of efficacy is of no use if nobody gets vaccinated." 

Agence France-Presse

Moderna closes in on release of COVID-19 vaccine data

BENGALURU/NEW JERSEY - Moderna Inc said on Wednesday it has enough data for a first interim analysis of the late-stage trial of its experimental COVID-19 vaccine, which should help determine the vaccine's efficacy.

Moderna said the information is being prepared for submission to the trial's independent data safety monitoring board, which will look at the results and make a recommendation. It did not say when it plans to release the efficacy data.

The company said in a news release that it has seen a significant increase in the number of COVID-19 cases among trial participants as infection rates have surged around the United States.

Due to the spike in cases, the analysis will cover substantially more than 53 infections, which had been the targeted trigger point for the first analysis.

The company said the trial remains blinded, so neither it nor study investigators know which participants received the vaccine or a placebo. The vaccine will be deemed a success if the overwhelming majority of those infected had received a placebo, once the monitoring board looks at the early results.

Earlier in the day, Dr. Anthony Fauci, the top U.S. infectious disease expert, said Moderna could have the data from anywhere between "a couple of days" to "a little more than a week."

A high degree of effectiveness would make sense as it is "almost identical" to Pfizer Inc's experimental vaccine, Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said at a conference organized by the Financial Times.

"It may not be 95 percent, it might be 90 percent, or 96 percent, or 89 percent, but it is going to be up there," he said.

Pfizer on Monday said its COVID-19 vaccine was more than 90 percent effective based on interim trial results, significantly higher than the at least 50% efficacy regulators are looking for.

Moderna, which uses a similar messenger RNA technology as Pfizer, said earlier on Wednesday that its November timeline for initial data was on track.

It did not respond to a Reuters request for comment on when it would disclose the data.

The company would still have to wait for two-month follow-up safety data required by the U.S. Food and Drug Administration, which it expects to have in the second half of this month, before applying for U.S. emergency use authorization.

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

Moderna's shares closed up 8.4 percent at $82.44 and rose to $83.85 in extended trading.

-reuters-

US floats idea of early approval for eventual vaccine

WASHINGTON - The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness. 

A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times. 

"If they do that before the end of Phase Three," which involves large-scale human testing, "we may find that appropriate. We may find that inappropriate, we will make a determination.”

But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.

"This is going to be a science, medicine, data decision," Hahn said. "This is not going to be a political decision."

Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.

The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance.

By the nature of the trials it is difficult to predict when reliable results will emerge.

Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo. 

Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically significant difference in the infection rate of the two groups.

As the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials -- drawing criticism from public health officials in other countries, including the US.

Hahn also said that an emergency authorization would not necessarily cover everyone -- it might be granted for specific, high-risk groups.

"Our emergency use authorization is not the same as a full approval," he said.

Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents.

In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.

More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.

"It is f-ing outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA's subservience to Trump," Eric Topol, director of the Scripps Research Translational Institute, said on Twitter.

"We will not know about safety for many months."

Agence France-Presse

Moderna begins first US late-stage vaccine trial

The first large study of safety and effectiveness of a coronavirus vaccine in the United States began Monday morning, according to the National Institutes of Health and biotech company Moderna, which collaborated to develop the vaccine.

A volunteer in Savannah, Georgia, received the first shot at 6:45 a.m., Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a news briefing.

The study, a Phase 3 clinical trial, will enroll 30,000 healthy people at about 89 sites around the country this summer. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who will get the real vaccine.

Researchers will then monitor the subjects, looking for side effects. And their main goal will be to see if significantly fewer vaccinated people contract COVID-19, to determine whether the vaccine can prevent the illness. The study will also try to find out if the vaccine can avert severe cases of COVID and death; if it can block the infection entirely, based on lab tests; and if just one shot can prevent the illness.

Fauci estimated that the full enrollment of 30,000 people would be completed by the end of the summer and that results might be available by November. Findings might emerge even earlier, he said, but added that he doubted it. He said that the high rates of transmission in some parts of the country, though unfortunate, would help speed up the process of determining whether the vaccine works.

Overall, a total of 150 to 160 coronavirus infections in the study will be enough to determine whether the vaccine is acceptably effective — that is, if it protects 60 percent of those who receive it, Fauci said.

Ideally, he would like the figure to be higher, but he said 60 percent “would be a major, huge step at controlling this outbreak; we’ll take that amount.”

Dr. Francis Collins, director of the National Institutes of Health, said the US government was reaching out to groups hit hardest by COVID — older people, those with chronic diseases, Blacks, Latinx and Native Americans — to encourage them to participate in the study. He said that the pandemic had put health disparities into “sharp relief” and that extra efforts were needed to gain the trust of people in those groups who might be reluctant to sign up for a medical experiment.

Earlier tests of Moderna’s vaccine showed that it stimulated a strong immune response, with minor and transient side effects like sore arms, fatigue, achiness and fever. But exactly what type of immune response is needed to prevent the illness is not known, so Phase 3 studies are essential to determine whether a vaccine really works.

In a statement, Collins said, “Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people.” He said that despite the unprecedented speed in bringing this experimental vaccine to human testing, “the most stringent safety measures” were being maintained.

Moderna said in a statement that it would be able to deliver about 500 million doses a year and possibly up to 1 billion doses per year, starting in 2021. The Massachusetts-based company, which has received nearly $1 billion from the federal government to develop a coronavirus vaccine, has said it will not sell the vaccine at cost, but for profit.

Moderna has not said what it will charge.

“We will price it responsibly during the pandemic, to make sure it is broadly accessible,” a spokesman, Ray Jordan, said in an email. The company may change the price later, when the virus becomes endemic, “but that is not something we have settled at this time,” Jordan said.

Moderna shares were up 8% at $79 in midday trading Monday.

The company’s vaccine uses a synthetic version of genetic material from part of the coronavirus, encased in tiny particles made of fat that help it get into human cells. The genetic material, called messenger RNA, or mRNA, then prompts the cells to churn out a tiny piece of the virus, which the immune system sees as foreign and learns to recognize. If the person is later exposed to the real virus, the immune system will attack it.

Messenger RNA has not yet produced any approved vaccines, but other companies have also invested in the approach because of its potential to produce vaccine quickly. The government announced last week that it had reached a $1.95 billion deal to buy 100 million doses of an mRNA vaccine made by Pfizer, in partnership with German company BioNTech, by the year’s end. That vaccine is also expected to begin Phase 3 trials soon, and the government will buy it only if the trial proves it safe and effective. CureVac and Sanofi are also working on mRNA vaccines.

At the news briefing, Collins said that three more Phase 3 trials would be starting soon, each needing 30,000 patients. Those trials will involve vaccines made by Novavax, Johnson & Johnson and a collaboration of the University of Oxford and AstraZeneca. All three companies are part of the Trump administration’s Operation Warp Speed.

Adults interested in participating in the Moderna trial can visit coronaviruspreventionnetwork.org or clinicaltrials.gov and search identifier NCT04470427.

-The New York Times Company-

US doubles spending on potential virus vaccine to nearly $1 billion

WASHINGTON - The United States has doubled its investment -- to nearly $1 billion -- to expedite development of a potential COVID-19 vaccine by American firm Moderna, which on Monday begins the decisive final phase of clinical trials.

The government now plans to spend up to $472 million on top of the previously announced $483 million, the Moderna biotechnology company announced Sunday.

Moderna said the added investment was justified by its decision, in conjunction with the government, to "significantly" expand a Phase Three clinical trial of a candidate vaccine to include 30,000 participants. 

In a small, initial trial, Moderna's experimental vaccine produced coronavirus antibodies -- which should help fend off the disease -- in the bodies of all 45 participants. 

In the expanded trial starting Monday, half the 30,000 participants will receive a 100-microgram dose of the vaccine, while the rest will be given a placebo. 

The United States has suffered more than 146,000 coronavirus deaths, leading the world in that grim category, even as the number of new cases has continued to surge. 

It has announced massive investments in a huge effort to expedite vaccine development and get millions of Americans vaccinated by early next year.

On Wednesday, the American-German BioNTech/Pfizer pharmaceutical alliance announced that the US government had committed $1.95 billion to procure 100 million doses of its eventual vaccine.

With laboratories around the world in a furious race to develop a first effective vaccine, Moderna seems to hold the lead as it enters a final round of clinical trials -- a decisive step in determining whether a vaccine is both effective and safe. 

Moderna, which has been working with US health authorities, said it expects to be able to produce 500 million doses a year -- and potentially up to 1 billion -- starting in 2021.

Chinese biotech firm Sinovac said July 6 that it, too, would begin a Phase Three clinical trial "this month," in collaboration with Brazil's Butantan biologic research center. 

Also reporting encouraging early results have been a British project developed by Oxford University in partnership with the multinational AstraZenica laboratory, and a Chinese project, led by researchers from agencies including the Academy of Military Medical Sciences.

That effort is being financed by the CanSino biotechnology group, which is listed on the Hong Kong stock exchange. 

In all, nearly 200 candidate vaccines are in development, including 23 now in the clinical phase, being tested on humans.

Agence France-Presse

Moderna vaccine induced antibodies in all trial participants: paper

WASHINGTON - An experimental COVID-19 vaccine that is being developed by US biotech firm Moderna induced antibody responses against the coronavirus in all 45 participants of a human trial, a paper published Tuesday showed.

Moderna had previously published "interim results" from its Phase 1 in the form of a press release on its website in May, which revealed the vaccine had generated immune responses in eight patients.

Though these were called "encouraging" by Anthony Fauci, the top US infectious diseases official, the full study had been eagerly awaited by the scientific community.

The company has since moved to the next stage of its trial, involving 600 people.

The new paper was published in the New England Journal of Medicine.

The 45 participants were split into three groups of 15 each to test doses of 25 micrograms, 100 micrograms and 250 micrograms.

They were given a second dose 28-days-later.

After the first round, antibody levels were found to be higher with higher level doses, and after the second round, participants had higher levels of antibodies than most patients who have COVID-19 and gone on to generate their own antibodies.

More than half the participants experienced mild or moderate side-effects, though these did not rise to the level where the trial would be called off. 


The side effects included fatigue, chills, headache, body ache, and pain at the injection site.

Three participants did not receive their second dose, including one in the 25 microgram group who developed a skin rash on both legs, and two (one in the 25 microgram group, one in 250 groups) who missed their window because they had COVID-19 symptoms, but their tests later returned negative.

Andrew Freedman, an infectious disease expert at the University of Cardiff who was not involved in the study, said the paper suggested the vaccine "is able to stimulate antibody production in a dose-dependent fashion."

"Importantly, the antibodies generated were able to neutralize the virus" in lab conditions, he added.

"The side effects experienced by more than half the participants are quite common after other vaccinations, although the 'more severe adverse events' experienced by three of the subjects given the highest dose may mean that dose is too high to take forward," he said.

The Moderna vaccine belongs to a new class of vaccine that uses genetic material, in the form of RNA, to encode the information needed to grow the virus' spike protein inside the human body, in order to trigger an immune response. 

The spike protein is a part of the virus it uses to invade human cells, but by itself is relatively harmless.

Agence France-Presse

Moderna COVID-19 vaccine appears to clear safety hurdle in mouse study

CHICAGO - A series of studies in mice of Moderna Inc's COVID-19 vaccine lent some assurance that it may not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday.

Prior studies on a vaccine for SARS - a close cousin to the new virus that causes COVID-19 - suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response.

Scientists have seen this risk as a hurdle to clear before vaccines can be safely tested in thousands of healthy people.

While the data released by the US National Institutes of Allergy and Infectious Disease (NIAID) and Moderna offered some assurance, the studies do not fully answer the question.

"This is the barest beginning of preliminary information," said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer review.

Poland said the paper was incomplete and disorganized, and the numbers of animals tested were small.

The authors said they have submitted the work to a top-tier journal. Moderna's vaccine is in midstage testing in healthy volunteers. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July.

In the animal studies, mice received one or two shots of a variety of doses of Moderna's vaccine, including doses considered not strong enough to elicit a protective immune response. Researchers then exposed the mice to the virus.

Subsequent analyses suggest "sub-protective" immune responses do not cause what is known as vaccine-associated enhanced respiratory disease, a susceptibility to more severe disease in the lungs.

"Subprotective doses did not prime mice for enhanced immunopathology following (exposure)," Dr. Barney Graham of the Vaccine Research Center at NIAID and colleagues wrote in the manuscript, posted on the bioRxiv website.

Further testing suggested the vaccine induces antibody responses to block the virus from infecting cells.

The vaccine also appeared to protect against infection by the coronavirus in the lungs and noses without evidence of toxic effects, the team wrote.

They noted the mice that received just one dose before exposure to the virus seven weeks later were "completely protected against lung viral replication," suggesting a single vaccination prevented the virus from replicating in the lungs.

"At first glance, it looks promising in inducing neutralizing antibody protection in mice," Dr. Peter Hotez, a researcher at Baylor College of Medicine said in an email. He had not reviewed the paper in detail.

Poland, who was not involved with the research, said the paper leaves out "important parameters" that could help scientists judge the work.

"The results, such as they are presented, provide interesting data that are reassuring... This needs to be replicated and it needs to be peer-reviewed," he said.

-reuters-

US drugmaker to start final testing stage of coronavirus vaccine in July

CHICAGO - Moderna Inc on Thursday confirmed it plans to start a trial of 30,000 volunteers of its much-anticipated coronavirus vaccine in July as the company enters the final stage of testing.

The Cambridge, Massachusetts-based biotech said the primary goal of the study would be to prevent symptomatic COVID-19, the disease caused by the novel coronavirus. The key secondary goal would be prevention of severe disease, as defined by keeping people out of the hospital.

The company's shares jumped 6 percent in premarket trading.

Moderna said it has selected the 100-microgram dose of the vaccine for the late-stage study. At that dose level, the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021 from the company's internal US manufacturing site and strategic collaboration with Swiss drugmaker Lonza.

The company said it chose the 100-microgram dose to maximize the immune response and minimize adverse reactions.

Moderna said is has completed manufacturing of enough vaccine to start the phase 3 trial.

In the midstage study, the company said it has enrolled 300 healthy adults, who have each been dosed with at least one shot, as well as the first 50 older adults, aged 18 to 54.

Testing the vaccine in older adults will be critical because this group is at higher risk for the most severe effects of the virus, and older adults typically have less efficient immune function. The midstage study is testing the safety and preliminary effectiveness of 2 doses of the vaccine given 28 days apart.

Study participants will be followed for a year.

-reuters-

US drugmaker reports promising early results from COVID-19 vaccine test

WASHINGTON - US biotech firm Moderna reported promising early results on Monday from the first clinical tests of an experimental vaccine against the novel coronavirus performed on a small number of volunteers.

The Cambridge, Massachusetts-based company said the vaccine candidate, mRNA-1273, appeared to produce an immune response in eight people who received it similar to that seen in people convalescing from the virus.

"These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection," said Moderna's chief medical officer Tal Zaks.

"These data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials," Zaks said.

President Donald Trump welcomed the news saying "it's incredible what they can do and I've seen results.

"And the results are staggeringly good," Trump told reporters. "So I'm very happy and the market's up very big."

Wall Street stocks posted substantial gains on Monday with the Dow Jones Industrial Average adding 3.85 percent and the S&P 500 up 3.15 percent.

Moderna shares gained 19.96 percent to close at $80.00 in New York.

Moderna, which was founded nine years ago, said the vaccine "was generally safe and well tolerated" and that patients suffered no more than redness or soreness from the shots.

In a conference call, Moderna chief executive Stephane Bancel said the preliminary tests inspired confidence that mRNA-1273 has "a high probability to provide protection" against the virus.

"We could not be happier about these interim data," Bancel said of the Phase 1 test, the first of three in the development of a vaccine. 

Separate tests performed on mice showed that the vaccine prevented the virus from replicating in their lungs, according to the company.

The US government has invested nearly half a billion dollars in the development of Moderna's vaccine candidate.

It is being developed in a partnership with the National Institute of Allergy and Infectious Disease headed by Anthony Fauci and the clinical test was carried out by the National Institutes of Health.

'AS FAST AS SAFELY POSSIBLY' 

Three groups of 15 patients aged 18 to 55 received three different doses of the vaccine in the Phase 1 test, the complete results of which are not yet known.

The Phase 2 trial, with 600 subjects, has already received the green light from the US Food and Drug Administration and Moderna said they should begin this quarter.

A Phase 3 trial, the largest and most important to validate the efficacy of a vaccine, should begin in July.

"The Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July," said Bancel, Moderna's CEO.

Based on the Phase 1 partial results, Moderna said they would no longer study the highest dose since the lower doses appeared to provide some effect.

"The lower the dose, the more people we expect to be able to protect," said Moderna president Stephen Hoge.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said that while it was difficult to be sure of the results "from a press release," there was reason for optimism.

"It must be noted that this is a Phase 1 study which has an object of showing the vaccine is able to induce an antibody response and that the dose range is appropriate," Evans said.

"It will not be until the Phase 3 trial is completed that it will be known whether the vaccine actually prevents COVID-19 disease," he added.

Trump has said he wants 300 million vaccine doses by January 2021 to protect the US population and his administration has provided funding to Moderna, Johnson & Johnson, and France's Sanofi.

The development of a vaccine usually takes years but the coronavirus pandemic, which has caused more than 315,000 deaths, has given unprecedented urgency to the search.

A dozen clinical trials are taking place around the world, half of them in China, according to the London School of Hygiene & Tropical Medicine.

China has said that it is carrying out tests on humans of 5 experimental vaccines.


The challenge is not only finding a safe and efficient vaccine but also producing billions of doses. 

Several large laboratories, including Moderna, have said they would immediately begin production of an eventual vaccine even before the completion of all of the clinical trials.

Moderna recently announced a partnership with the giant drugmaker Lonza to boost its manufacturing capacity to up to one billion doses a year.

Agence France-Presse 

US firm announces 'positive interim' results for coronavirus vaccine

US biotech firm Moderna reported "positive interim" results on Monday in the first clinical tests of its vaccine against the new coronavirus performed on a small number of volunteers.

The vaccine, mRNA-1273, appeared to produce an immune response in eight people who received it, of the same magnitude as that observed in people convalescing from the virus, the company said.

The complete results of the phase 1 test, the first in the development of a vaccine and which in this case involved 45 participants, were not yet known.

The vaccine "was generally safe and well tolerated," Moderna said in a statement.

"These interim phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection," Tal Zaks, Moderna's chief medical officer, said.

The clinical test was carried out by the National Institutes of Health, and the US government has invested a half billion dollars in the development of Moderna's vaccine candidate.

Three groups of 15 patients received three different doses of the vaccine.

Phase 2 tests, with a larger number of subjects, should begin soon, and according to Moderna. The phase 3 trial, the last and most important to validate the efficacy of a vaccine, should begin in July.

Separate tests performed on mice showed that the vaccine prevented the virus from replicating in their lungs, according to the company.

"The Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July," said Stephane Bancel, Moderna's CEO.

Agence France-Presse