UC San Diego scientists said Sunday night theyre hustling to find samples of the Omicron variant of the coronavirus to help in the worldwide effort to assess whether it is more transmissible and harmful than earlier versions of the virus.
Its possible that the new variant could be discovered this week in San Diego County through the genetic analysis that UC San Diego is doing on positive coronavirus tests, a campus official said.
The county health department and some hospitals also are conducting such testing.
Its only a matter of time and testing before we find it here, said Dr. Davey Smith, head of infectious diseases at UC San Diego, which was one of the first universities to broadly test students, faculty and staff for COVID-19.
UC San Diego scientists also helped to conduct COVID-19 vaccine trials on behalf of Moderna, Johnson & Johnson nd AstraZeneca, and it has been testing therapeutic drugs on patients.
Scripps Research also said late Sunday that it is geared up to evaluate Omicrons potential threat to public health.
Smith said scientists are just beginning to understand Omicron, but added, The vaccines we have now should work quite well against it. People should be getting vaccinated, and getting their boosters.
UC San Diego has about 8,500 international students, most of whom will resume the fall quarter on Monday. Some of the students traveled back to their home countries during the Thanksgiving break. The university hosts many students from overseas, including the United Kingdom, which has reported Omicron cases.
But campus officials say the school is likely to continue having a tiny infection rate because it will be screening all dorm students for the virus. UC San Diego also has been strongly enforcing social-distancing rules.
Before the start of the Thanksgiving holiday, the infection rate among students who access the campus was 0.22 percent.
But there is a lot of uneasiness about the new variant.
Were hampered by the fact that nothing is yet in the peer reviewed scientific literature, said Robert Chip Schooley, who leads UC San Diegos Return to Learn program.
Ive been in contact with a colleague from Hong Kong that I trust and respect more than anyone in virology. He has been working with the virus in his laboratory and has been observing it epidemiologically.
His take is that it is, indeed, highly contagious but that vaccinated people who become infected have relatively mild (breakthrough-like) symptoms.
Schooley said he believes the virus is more aggressive about shutting down the innate immune response than the Alpha and Delta variants, which he said will allow it to grow to much higher tiers during the pre-symptomatic phase. This, in turn, will result in higher transmissibility and (likely) more severe disease in the unvaccinated, he said
Schooley added, Were not currently planning on changing our policies vis--vis holiday travel but, as with other aspects of our adaptive response posture we will be monitoring the situation on a daily basis and modifying our approach as conditions dictate.
As nations severed air links from southern Africa amid fears of another global surge of the coronavirus, scientists scrambled on Sunday to gather data on the new Omicron variant, its capabilities and perhaps most important how effectively the current vaccines will protect against it.
The early findings are a mixed picture. The variant may be more transmissible and better able to evade the bodys immune responses, both to vaccination and to natural infection, than prior versions of the virus, experts said in interviews.
The vaccines may well continue to ward off severe illness and death, although booster doses may be needed to protect most people. Still, the makers of the two most effective vaccines, Pfizer-BioNTech and Moderna, are preparing to reformulate their shots if necessary.
We really need to be vigilant about this new variant and preparing for it, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.
Probably in a few weeks, well have a better sense of how much this variant is spreading and how necessary it might be to push forward with a variant vaccine, Dr. Bloom said.
Even as scientists began vigorous scrutiny of the new variant, countries around the world curtailed travel to and from nations in southern Africa, where Omicron was first identified. Despite the restrictions, the virus has been found in a half-dozen European countries, including the United Kingdom, as well as Australia, Israel and Hong Kong.
Already, Omicron accounts for most of the 2,300 new daily cases in the province of Gauteng, South Africa, President Cyril Ramaphosa announced on Sunday. Nationally, new infections have more than tripled in the past week, and test positivity has increased to 9 percent from 2 percent.
Scientists have reacted more quickly to Omicron than to any other variant. In just 36 hours from the first signs of trouble in South Africa on Tuesday, researchers analyzed samples from 100 infected patients, collated the data and alerted the world, said Tulio de Oliveira, a geneticist at the Nelson R. Mandela School of Medicine in Durban.
Within an hour of the first alarm, scientists in South Africa also rushed to test coronavirus vaccines against the new variant. Now, dozens of teams worldwide including researchers at Pfizer-BioNTech and Moderna have joined the chase.
They wont know the results for two weeks, at the earliest. But the mutations that Omicron carries suggest that the vaccines most likely will be less effective, to some unknown degree, than they were against any previous variant.
Based on lots of work people have done on other variants and other mutations, we can be pretty confident these mutations are going to cause an appreciable drop in antibody neutralization, Dr. Bloom said, referring to the bodys ability to attack an invading virus.
South African doctors are seeing an increase in reinfections in people who already had a bout of Covid-19, suggesting that the variant can overcome natural immunity, said Dr. Richard Lessells, an infectious diseases physician at the University of KwaZulu-Natal.
Omicron has about 50 mutations, including more than 30 in the spike, a viral protein on its surface that the vaccines train the body to recognize and attack.
Some of these mutations have been seen before. Some were thought to have powered the Beta variants ability to sidestep vaccines, while others most likely turbocharged Deltas extreme contagiousness.
My best guess is that this combines both of those elements, Penny Moore, a virologist at the National Institute for Communicable Diseases in South Africa, said of the new variant.
But Omicron also has 26 unique spike mutations, compared with 10 in Delta and six in Beta. Many of them seem likely to render the variant more difficult for the immune system to recognize and thwart.
There are many weve never studied before, but just looking at the location on the spike, they are in regions that we know are immuno-dominant, Dr. Moore said, referring to parts of the spike protein that interact with the bodys immune defenses.
Dr. Moores team is perhaps the furthest along in testing how well the vaccines hold up against Omicron. She and her colleagues are preparing to test blood from fully immunized people against a synthetic version of the Omicron variant.
Creating such a pseudovirus a viral stand-in that contains all of the mutations takes time, but results may be available in about 10 days.
To more closely mimic what people are likely to encounter, another team led by Alex Sigal, a virologist at the Africa Health Research Institute, is growing live Omicron, which will be tested against the blood of fully immunized people, as well as those who were previously infected.
Nov. 29, 2021, 9:49 a.m. ET
Those results may take longer but should provide a fuller picture of the vaccines performance, Dr. Sigal said.
If the vaccines prove to be much less potent against Omicron, they may need to be tweaked to enhance their effectiveness. Preparing for the worst, Moderna, Pfizer-BioNTech and Johnson & Johnson are planning to test an artificial version of Omicron against their vaccines.
The mRNA vaccines in particular Modernas and Pfizer-BioNTechs were built with technology that should permit rapid modification. Pfizers scientists can adapt the current vaccine within six weeks and ship initial batches within 100 days in the event of an escape variant that eludes the immune system, said Jerica Pitts, a spokeswoman for Pfizer.
Modernas work began on Tuesday, immediately after its scientists learned of Omicron the fastest the company has ever responded to a variant, said Dr. Stephen Hoge, Modernas president.
Even without data on Omicrons spread, it was obvious the variant would be a formidable threat to vaccines, he said.
This thing is a Frankenstein mix of all of the greatest hits, Dr. Hoge said, referring to the variants many concerning mutations. It just triggered every one of our alarm bells.
Moderna could update its current vaccine in about two months and have clinical results in about three months if necessary, he said.
Both companies also plan to test whether booster shots will bolster the immune system enough to fend off the new variant. Boosters of the Pfizer-BioNTech and Moderna vaccines have been shown to raise antibody levels significantly.
But those antibodies may not be broadly effective against every iteration of the virus, and may not be enough to neutralize Omicron entirely, said Michel Nussenzweig, an immunologist at Rockefeller University in New York.
People who recover from Covid and then receive even one dose of a vaccine tend to produce a broader range of antibodies, capable of recognizing more versions of the virus, than do people who are only vaccinated.
Its clear that hybrid immunity, the kind that people get when they are both infected and vaccinated, is superior, and that is very, very likely to take care of this thing, too, Dr. Nussenzweig said.
Understand the Omicron Variant
Scientists are racingto learn more about the Covid variant. Heres the latest.
After two doses of vaccine, we did not see that. But were hoping that after three doses, maybe therell be some catching up, he said.
Dr. Nussenzweig and his colleagues are preparing to test Omicron against the mRNA vaccines, as well as the vaccines made by Johnson & Johnson and AstraZeneca. They hope to have results within a month.
Omicron-specific vaccines created in just weeks would be a miraculous feat. But the prospect of producing and distributing them raises daunting questions.
If new versions are required to protect people everywhere, companies should make them available to the African countries that most need them and can least afford them, Dr. de Oliveira said.
South Africa at least has managed to procure their own vaccines, he said. But poorer countries like Sudan, Mozambique, Eswatini and Lesotho will need low-cost options.
Pfizer did not respond to a question about low-cost vaccines for African nations. Dr. Hoge, of Moderna, said the company already had an agreement with the African Union to deliver 110 million doses at $3.50 per half dose of vaccine.
Dr. Hoge said he recognized that 110 million was less than 10 percent of Africas population. But, he noted, were also the smallest of all manufacturers out there, and so 10 percent hopefully is useful.
Despite the frustration that South African scientists have expressed about vaccine inequity and punishing travel restrictions, they have been inundated with requests for genetic sequences of Omicron from Italy, Germany, Australia and New Zealand, as well as labs in North America.
The more teams involved, the better, said Dr. Moore, who received about 50 requests just on Saturday. As the virus moves across the globe, it is likely to keep changing. Getting the right combination of mutations in itself is a moving target, she said.
Researchers everywhere want to avoid drawing conclusions prematurely, a mistake they made when the Beta variant surfaced. Preliminary tests of that variant took only one known mutation into account and underestimated its ability to evade the immune system, Dr. Moore recalled. (Fortunately, the variant also turned out to be less contagious.)
To get a full picture of the effectiveness of the vaccines against Omicron, scientists must look not just at antibody levels but also at immune cells that can recognize and destroy infected cells. Immune cells called T cells are crucial for preventing an infection from progressing to serious illness and death.
Some of Omicrons mutations occur in parts of the virus targeted by T cells, meaning the variant may be more difficult for T cells to recognize.
Already, a computer simulation has predicted that those mutations may alter about six of the hundreds of regions that T cells can recognize, said Wendy Burgers, an immunologist at the University of Cape Town.
That may not seem like much. But people make varying sets of T cells, so depending on which targets the mutations knock out, some people may barely be affected by Omicron and others may be left vulnerable.
Dr. Burgers is hoping to obtain blood from 50 people infected with the variant to gauge how the mutations will play out across a population. Once the samples are in hand, results will be available after probably a week of very late nights and analysis, she said.
Even if the vaccines hold up against Omicron, new versions will probably be needed at some point, and perhaps soon. The virus is acquiring mutations much faster than expected, Dr. Bloom said.
Seasonal influenza is the often cited example of a virus that mutates quickly, requiring regular updates to vaccines. But the coronavirus is at least comparable and possibly even faster than that, Dr. Bloom said. Theres always going to be new variants arising.
Lynsey Chutel contributed reporting from South Africa.
People line up to get on the Air France flight to Paris at OR Tambo's airport in Johannesburg, South Africa, on Friday. The United States, Israel and other European nations have already imposed travel restrictions on South Africa and other nations in the region. Jerome Delay/AP hide caption
People line up to get on the Air France flight to Paris at OR Tambo's airport in Johannesburg, South Africa, on Friday. The United States, Israel and other European nations have already imposed travel restrictions on South Africa and other nations in the region.
When the omicron variant of COVID-19 was first identified in South Africa, the country's scientists were quick to inform global health leaders of the new mutations they had found.
Though scientists have little information about the new variant and aren't certain where it originated, several countries, including the United States, Canada, the United Kingdom and the European Union announced almost immediate travel bans from South Africa and other southern African nations.
As the week began, Japan followed suit with far more restrictive measures.
Japanese Prime Minister Fumio Kishida announced Monday the decision to reestablish entry rules for foreign travelers to limit any potential spread of the omicron variant. This comes just weeks after the country reopened its borders on Nov. 8.
Kishida told reporters this step is a "temporary measure until information about the omicron variant becomes clear."
Israel also implemented a blanket ban to all foreigners Sunday night after initially establishing restrictions on travelers just from southern African countries. According to The Jerusalem Post, under this new policy anyone returning from any country vaccinated Israelis included will need to isolate for three days once in the country.
The restrictive measures around the world sparked outcry from some health officials and experts who caution that the bans are premature and could set a harmful precedent.
"There is very little utility of these kinds of bans," Saad Omer, director of the Yale Institute of Global Health, told NPR.
"Unfortunately, from what we know about the epidemiology of SARS-CoV-2 and the epidemiology of this variant, the horse has probably left the barn," Omer said, noting the high transmissibility of this coronavirus and its variants.
And even though the omicron variant has been reported in several other countries in Europe, Asia and North America, travel bans are largely being imposed on southern African countries.
One of the identified cases of the omicron variant in Belgium had no contact or travel with any nations in southern Africa, suggesting community spread could already be taking place.
"If the question is to prevent the variant from coming in, it really doesn't make sense to exempt countries where it has been identified and that has even more direct flights than southern Africa," Omer said.
Travel bans from the start of the COVID-19 pandemic resulted in economic and other consequences we're still seeing today.
A recent study from the journal Science shows that restricting international travel in the beginning stages of the COVID-19 pandemic did have some effect on delaying spread, but the researchers said restricting travel is only truly effective when paired with curbing the spread of infection through hand-washing, isolation and early detection.
Another study, in the Journal of Emergency Management, concluded that little evidence exists to prove that international travel bans are effective in controlling the spread of infectious disease, and such measures should only be taken if recommended by the World Health Organization. With the omicron variant, the WHO has already cautioned against imposing travel bans.
Introducing a travel ban can also give a false sense that the virus is being contained, researchers said, adding that such policies can also make it difficult to transport health care workers and other resources.
Additionally, the stigma of travel bans can exacerbate racism and xenophobia, according to Nicole Errett of the University of Washington, who was the lead author on the Journal of Emergency Management study.
Omer, of the Yale Institute of Global Health, has another concern about implementing travel bans during a public health crisis: It can dampen the commitment to scientific transparency.
When countries that are proactive about disclosing the circulation of a virus are hit with travel restrictions, he said, that undercuts the case for health officials to be forthcoming about what's happening in their countries.
"You don't want a situation where, a month from now, a country health minister ... gets a result of sequenced virus and they say, 'OK, if it is that widespread, it's going to come out anyways from some other country, why be the first one?' And that cycle starts," said Omer.
Addressing vaccine inequity around the world is the best way to stop these new variants from emerging, Omer said.
"If there are more transmission events going on with every hour, with every day, with every week, the likelihood of a variant emerging goes up," he said.
And one of the most effective ways to address inequity, Omer said, is to allow for all regions, low-income countries in particular, to produce their own vaccines.
It's too early to tell whether the omicron variant in particular will become a serious public health threat, Omer added, "but that doesn't mean that we are not playing with fire by by letting vaccine inequity continue."
Nov 29, 2021, 12:24pmUpdated 3h ago
By: Associated Press
Portuguese health authorities said Monday they have identified 13 cases of omicron, the new coronavirus variant believed to be more contagious, among team members of a professional soccer club.
The Ricardo Jorge National Health Institute said Monday that one of those who tested positive at the Lisbon-based Belenenses soccer club had recently traveled to South Africa, where the omicron variant was first identified.
The others, however, had not traveled to South Africa, indicating that this may be one of the very first cases of local transmission of the virus outside of southern Africa.
Those who have been in contact with the positive cases have been ordered to isolate, regardless of their vaccination status or their exposure to possible contagion, and will be regularly tested for COVID-19, the institute said.
As cases of a new coronavirus variant are confirmed around the world, Japan announced Monday that it will suspend entry of all foreign visitors, joining an increasing number of countries that are tightening their borders as fear spreads of yet another extension of pandemic suffering.
Japan, which has yet to detect any cases of the recently identified omicron variant, reimposed border controls that it eased earlier this month for short-term business visitors, foreign students and workers.
Despite the global worry, however, scientists cautioned that it's still unclear whether omicron is more dangerous than other versions of a virus that has killed more than 5 million people. Some countries are continuing with previous plans to loosen restrictions, with signs of reopening in Malaysia, Singapore and New Zealand.
We are taking the step as an emergency precaution to prevent a worst-case scenario in Japan, Prime Minister Fumio Kishida said of the measure that begins Tuesday. Japan has kept its border closed to foreign tourists from all nations.
Kishida urged people to continue wearing masks and pursuing other basic anti-virus measures until further details of the new omicron variant are known.
Kishida, whose predecessor lost his job in part because of disappointment over his handling of the virus, was not alone in choosing an aggressive approach until details of what omicron can do emerge.
Israel decided to bar entry to foreigners, and Morocco said it would suspend all incoming flights for two weeks starting Monday - among the most drastic of the growing raft of travel curbs being imposed by nations around the world as they scrambled to slow the variants spread. Scientists in several places - from Hong Kong to Europe to North America - confirmed its presence.
On Monday, the Scottish government announced the discovery of six new cases of the omicron variant of coronavirus, taking the U.K. total to nine. It has asked public health authorities to undertake enhanced contact tracing in all cases. Over the weekend, British health authorities found three cases of the variant.
Others to report new cases over the weekend were the Netherlands, which has 13 confirmed cases, while Canada has found two.
In Malaysia, however, officials went ahead with the partial reopening of a bridge connecting it to the island city-state of Singapore. And New Zealand announced it will continue plans to reopen internally after months of shutdown, while also restricting travel from African nations.
The World Health Organization, noting that the variant has already been detected in many countries and that closing borders often has a limited effect, called for frontiers to remain open.
The variant was identified days ago by researchers in South Africa, and much about it is still unclear, including whether it is more contagious, more likely to cause serious illness or more able to evade the protection of vaccines.
Health officials in Australia's Northern Territory announced that the state confirmed its first case of omicron on Monday, a South African man who flew into Darwin last Thursday. Australian Health Minister Greg Hunt said the prime minister is convening the National Security Committee to review actions that could be taken over omicron.
In New South Wales, Premier Dominic Perrottet said Monday there could be a third omicron case in his state. Health authorities there announced Sunday that two travelers returning from South Africa had tested positive. They were asymptomatic and fully vaccinated. Arrivals from nine African countries are now required to quarantine in a hotel upon arrival.
New Zealand has restricted travel from nine southern African countries in response to the omicron threat, but Prime Minister Jacinda Ardern said she didnt anticipate any further restrictions.
And omicron hasnt changed New Zealands plans to ease restrictions in Auckland and move the nation into a new, more open phase of its pandemic response, Ardern said Monday. Bars, restaurants and gyms in Auckland can reopen from late Thursday, ending a coronavirus lockdown that began in August.
Weve come through the past two years of COVID in better shape than nearly anywhere in the world, Ardern said, pointing to low death rates, a growing economy and high vaccination rates.
Malaysians working in Singapore held joyful reunions with loved ones after returning to their homeland following the partial reopening of a land border that was shuttered for nearly two years because of the pandemic.
Buses ferried fully vaccinated passengers across the Causeway Bridge that connects the island of Singapore with the Malaysian peninsula. Strict measures included pre-departure and on-arrival COVID-19 tests.
Malaysias health minister tweeted that a COVID-19 case was detected during a screening, but didnt elaborate. The causeway was one of the worlds busiest land borders before the pandemic struck. Air travel also reopened with fewer restrictions, allowing anyone who is fully vaccinated to travel quarantine-free between the two countries.
Taiwan, which already has strict border entry controls, said its not planning to further tighten its COVID-19 border policies to protect against the omicron variant.
Taiwan requires a two-week quarantine on arrival. It also has restricted the issuing of visas and currently does not allow in foreigners, except those with residency permits and those who have special circumstances.
Health Minister Chen Shih-chung said officials are reserving rooms in government facilities for travelers from countries with reported omicron cases. The Central Epidemic Command Center listed six countries as high risk: South Africa, Botswana, Namibia, Lesotho, Eswatini, and Zimbabwe.
Taiwan is bracing for a surge of visitors ahead of the lunar new year, and has allowed those returning to complete the two-week quarantine partly at home. However, anyone arriving is still required to stick to the entire 14-day quarantine schedule and face fines if they break quarantine.
North Korea, which claims no virus cases and which has taken among the worlds harshest anti-virus measures, says its making all-out efforts to prevent omicron from entering the country. Many question its claim of being coronavirus-free. Since the start of the pandemic, North Korea has sealed off its international borders and jetted out diplomats.
Dr. Francis Collins, director of the National Institutes of Health in the United States, meanwhile, said no data as yet suggest the new variant causes more serious illness than previous COVID-19 variants.
I do think its more contagious when you look at how rapidly it spread through multiple districts in South Africa. It has the earmarks therefore of being particularly likely to spread from one person to another. What we dont know is whether it can compete with delta, Collins said on CNNs State of the Union.
Collins echoed several experts in saying the news should make everyone redouble their efforts to use the tools the world already has, including vaccinations, booster shots and measures such as mask-wearing.
The U.S. is banning travel from South Africa and seven other southern African countries starting Monday. Its going to give us a period of time to enhance our preparedness, the United States top infectious diseases expert, Dr. Anthony Fauci, said of the ban on ABCs This Week.
Fauci says it will take approximately two more weeks to have more definitive information on the transmissibility, severity and other characteristics of omicron, according to a statement from the White House.
South Africas government responded angrily to the travel bans, which it said are akin to punishing South Africa for its advanced genomic sequencing and the ability to detect new variants quicker.
David Hui, a respiratory medicine expert and government adviser on the pandemic in Hong Kong, said the two people who tested positive there for the omicron variant had received the Pfizer vaccine and exhibited very mild symptoms, such as a sore throat.
Vaccines should work but there would be some reduction in effectiveness, he said.
Gov. Phil Murphy received his coronavirus vaccine booster shot Sunday at the Monmouth Medical Center and encouraged other adult residents to get their shots as concerns mount over a new coronavirus variant and rising case numbers.
Murphy, 63, now joins more than 1.23 million people in New Jersey who have received third doses or boosters.
The governor, who recently returned from a three-night Thanksgiving trip to Orlando with his family, also posted photos on social media of his wife, First Lady Tammy Murphy, getting her booster shot and his family holding up their vaccine cards.
Murphy and his wife received their first coronavirus vaccine doses in April as they toured one of the states six vaccine mega-sites in Atlantic City. The couple both received the Pfizer vaccination.
On Sunday, they each received a third dose of the Pfizer vaccination.
Officials are encouraging everyone 18 and older in New Jersey who has received their second dose of the Pfizer and Moderna vaccines six months ago or longer to get a booster shot. Thats after the U.S. Centers for Disease Control and Prevention announced this month that it opened booster shot eligibility to all adults.
Anyone 18 and older who received the Johnson & Johnson vaccine was already eligible for a booster two months after the single shot.
More than 6.17 million people who live, work or study in New Jersey a state of about 9.2 million residents have now been fully vaccinated. More than 8 million people in the state have received at least one dose, and more than 1.23 million people have received third doses or boosters.
As of Monday, at least 87,500 children between the ages of 5 and 11 in New Jersey have received vaccine doses since federal authorities approved the Pfizer shots for that age group two weeks ago, according to the state.
Officials are urging all eligible residents receive a vaccine if they have not already, aiming to ward off a winter surge as coronavirus cases rise and holiday travel picks up.
On Sunday, New Jersey reported another 1,599 cases and an additional four deaths. The states seven-day average for new positive tests increased to 1,809, up 10% from a week ago and up 58% from a month ago.
In all, New Jersey, has reported 1,082,586 total confirmed cases out of more than 16 million PCR tests conducted since it announced its first case March 4, 2020. There have also been more than 164,627 positive antigen or rapid tests, which are considered probable cases.
The state of 9.2 million people has reported 28,250 have died from complications related to COVID-19 25,516 confirmed and 2,823 considered probable.
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Jackie Roman may be reached at jroman@njadvancemedia.com or on Twitter @JacqueRoman.
Experts warn about the mistakes people make with the COVID-19 vaccine. ETNT Health. Sure Signs You've Caught COVID After Your Vaccine. You may have a "breakthrough" case of COVID-19 and these are the signs. ETNT Health. Doctors Say "Do Not" Do This After Your COVID Booster.
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A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in Manhattan in New York City, New York, U.S., January 29, 2021. REUTERS/Mike Segar//File Photo
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Oct 25 (Reuters) - Moderna Inc (MRNA.O) said on Monday its COVID-19 vaccine generated a strong immune response in children aged six to 11 years and that it plans to submit the data to global regulators soon.
Moderna said its two-dose vaccine generated virus-neutralizing antibodies in children and safety was comparable to what was previously seen in clinical trials of adolescents and adults. It cited interim data that has yet to be peer reviewed.
It was unclear when U.S. regulators will weigh in on the shot. The Moderna COVID-19 vaccine is authorized for adults over the age of 18 years and is waiting for a response to its June application for children aged 12 through 17.
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It is behind rivals Pfizer Inc (PFE.N) and BioNTech SE , whose vaccine has been authorized for ages 12 and up since May. A panel of outside advisers to the U.S. Food and Drug Administration will meet on Tuesday to decide whether to recommend Pfizer's vaccine in children aged five to 11 years.
Moderna said that in its trial of 4,753 participants, side effects were mostly mild to moderate in severity. The most common side effects were fatigue, headache, fever and injection site pain.
The company statement did not disclose any new information about cases of heart inflammation called myocarditis, a known side effect of mRNA vaccines.
The shots were 50 microgram doses, half the strength used in the primary vaccine series for adults and the same as the booster dose authorized for adults. It is higher than the 10 microgram dose Pfizer is planning for its vaccine in children.
Both the Moderna and Pfizer/BioNTech vaccines have been linked to myocarditis in young men.
Some studies have suggested the rate of incidence in recipients of the Moderna vaccine may be higher than in Pfizer recipients, perhaps because of the stronger dose of vaccine.
Sweden has paused the use of the Moderna vaccine for younger age groups because of the higher risk of myocarditis.
While children rarely become seriously ill or die from COVID-19, some do develop rare complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.
Children can also spread the virus, infecting those who are not protected by vaccines and giving the virus more room to develop new variations.
Moderna shares rose 2% in morning trading.
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Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Shounak Dasgupta and Howard Goller
Our Standards: The Thomson Reuters Trust Principles.
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The outcome of the battle has important implications, not only for efforts to contain the pandemic but more broadly for drugs and vaccines that could be critical for future public health crises. I teach drug regulation and patent law at Saint Louis Universitys Center for Health Law Studies.
Moderna recently offered to share ownership of its main patent with the government to resolve the dispute. Whether or not this is enough to satisfy the governments claims, I believe the dispute points to serious problems in the ways U.S. companies bring drugs and vaccines to market.
U.S. was a major funder of the Moderna vaccine
Vaccines have played a crucial role in the response to the pandemic. In December 2020, Moderna became the second pharmaceutical company after Pfizer to obtain authorization from the Food and Drug Administration to market a COVID-19 vaccine in the United States. People have since grown so used to talking about the Moderna vaccine that a crucial element in the history of how it was developed risks being overshadowed: Moderna was not the sole developer of the vaccine.
Unlike many of the other pharmaceutical companies involved in the COVID-19 vaccine race, Moderna is a newcomer to drug and vaccine commercialization. Founded in Massachusetts in 2010, the company had never brought a product to market until the FDA authorized its COVID-19 vaccine last year. Throughout the 2010s, Moderna focused on the development of mRNA technology, attracting over US$2 billion in funding from pharmaceutical companies and other investors. It went public in 2018.
Even before the pandemic, research on both coronaviruses and vaccine candidates against emerging pathogens was a priority for agencies operating in the public health space. In 2015, the National Institute of Allergy and Infectious Diseases, an institute within the NIH, signed a cooperative R&D agreement with Moderna on basic research, including the development of new vaccines. The agreement resulted in an undisclosed amount of funding and assistance with research.
In addition, after the COVID-19 outbreak began Moderna also received almost $1 billion in funding from the Biomedical Advanced Research and Development Authority, which operates within the Department of Health and Human Services. This funding was specifically targeted to the development of a COVID-19 vaccine candidate.
Researchers have calculated that, collectively, the U.S. government has provided $2.5 billion toward the development and commercialization of Modernas COVID-19 vaccine.
U.S. and Moderna scientists working side by side
In addition to providing financial support, the federal government was instrumental in the development of Modernas vaccine for other reasons. Namely, federal scientists worked alongside Moderna scientists on different components of the vaccine. These contributions included working on dosing mechanisms, and the NIH said federal scientists created the stabilized spike proteins that are a key component of the vaccine made by Moderna.
The importance of the role played by federal scientists in their work with Moderna would soon become apparent. A 2019 agreement with a third party explicitly acknowledged this, alluding to mRNA vaccine candidates developed and jointly owned by NIAID and Moderna. And by late 2020, the U.S. government was calling it the NIH-Moderna COVID-19 vaccine.
While the U.S. government has spent money on COVID-19 vaccines made by other companies, its close involvement in the R&D stages of Modernas sets it apart.
How it became a patent dispute
As development of the vaccine progressed, Moderna applied for several patents, each one covering different components of the vaccine. U.S. law allows inventors to apply for patents on products or methods that are new, not obvious and useful. While some early modern vaccines like the polio vaccine developed by Jonas Salks team were not covered by patents, from the late 20th century onward it became very common for one or multiple patents to cover a newly developed vaccine.
In applying for some patents related to its vaccine, Moderna named National Institute of Allergy and Infectious Diseases scientists as co-inventors alongside Moderna scientists. This was the case, for example, in a patent application dated May 2020 for a relatively minor component of the vaccine.
However, in July 2021, Moderna made it clear that it would not name government scientists as co-inventors in a patent application covering a much more significant component of the vaccine: the mRNA sequence used to produce the vaccine, known as mRNA-1273.
Modernas position was that Moderna scientists alone had selected the sequence. The company informed the Patent and Trademark Office of its position in a 2020 statement. In November 2021, government officials publicly challenged the companys decision after months of failed negotiations with the company. Moderna then took to social media to defend its position, tweeting:
Just because someone is an inventor on one patent application relating to our COVID-19 vaccine does not mean they are an inventor on every patent application relating to the vaccine.
By contrast, the National Institutes of Health argued that three NIAID scientists Kizzmekia Corbett, Barney Graham and John Mascola had meaningfully contributed to the invention, though they have declined to publicly specify how. If true, patent law says they should be named co-inventors.
But this dispute is not merely about scientific principles or technical aspects of the law. While patents are also regarded as proxies for measuring scientific reputation, their most immediate and powerful effect is to give patent holders a significant amount of control over the covered technology in this case, the main component of the vaccine made by Moderna.
From a practical perspective, excluding federal scientists from the application means that Moderna alone gets to decide how to use the vaccine, whether to license it and to whom. If, by contrast, the government co-owns the vaccine, federal patent law allows each of the joint owners to engage in a variety of actions from making and selling the vaccine to licensing it without the consent of the other owners.
This is especially relevant in cases of product scarcity or potential pricing issues in connection with the commercialization of the vaccine. For instance, the U.S. would have the ability to allow more manufacturers to produce vaccines using the mRNA-1273 technology. In addition, it could direct vaccine doses wherever it likes, including to lower-income countries that have received few vaccines so far.
Broader implications
The ongoing battle between the government and an emerging star in the pharmaceutical industry is yet another episode in a complicated relationship between actors with complementary yet distinct roles in the production of drugs and vaccines. On the one hand, the federal government has long played a critical role in both performing and funding basic research. On the other, it does not have the resources and capacity to bring most types of new drugs and vaccines to market on its own.
The pharmaceutical industry thus plays an important and necessary role in drug innovation, which I believe should be rewarded although not boundlessly.
If the NIH is correct about co-ownership of the vaccine, then Moderna is unduly using a legal tool to achieve a position of market control a reward it does not deserve. This position of sole control becomes even more problematic in light of the significant amounts of public money that funded the development of this vaccine. This offset some of Modernas financial risk, even as the company projects to make $15 billion to $18 billion in revenue from vaccine sales in 2021 alone, with much more expected in 2022.
However, even if the NIH prevails in the patent dispute, it is important to understand the limitations of such a win. The U.S. would be in a position to license the vaccine, for example, and could do so by requiring that licensees agree to equitable distribution of vaccine doses.
But co-ownership would not enable the government to fix any of the other problems that currently affect the manufacturing and distribution of COVID-19 vaccines, such as scaling up production or building infrastructure to deliver vaccine doses.
In my view, the dispute is a reminder of the many problems embedded in how vaccines are made and delivered in the U.S. And it shows that when taxpayers fund basic research of a drug, they deserve more of the control and rewards when that drug succeeds.
