COVID-19 vaccine maker Moderna is suing Pfizer and the German drugmaker BioNTech, accusing its main competitors of copying Moderna’s technology in order to make their own vaccine. Moderna said Friday that Pfizer and BioNTech’s vaccine Comirnaty infringes on patents Moderna filed several years ago protecting the technology behind its preventive shot, Spikevax. The company filed patent infringement lawsuits in both U.S. federal court and a German court. Pfizer spokeswoman Pam Eisele said the company had not fully reviewed Moderna’s lawsuit, but the drugmaker was surprised by it, given that their vaccine is based on proprietary technology developed by both BioNTech and Pfizer. She said in an email that the company would “vigorously defend” against any allegations in the case. BioNTech did not immediately respond to a request from The Associated Press seeking comment. Moderna and Pfizer’s two-shot vaccines both use mRNA technology to help patients fight the coronavirus. The mRNA vaccines work by injecting a genetic code for the spike protein that coats the surface of the coronavirus. That code, the mRNA, is encased in a little ball of fat, and instructs the body’s cells to make some harmless spike copies that train the immune system to recognize the real virus.That approach is radically different than how vaccines have traditionally been made. Read: Int'l community urged to intensify pressure on Myanmar military to stop violence against its people Moderna said it started developing its mRNA technology platform in 2010, and that helped the company quickly produce its COVID-19 vaccine after the pandemic arrived in early 2020. By the end of that year, U.S. regulators had cleared shots from both Pfizer and Moderna for use after clinical research showed that both were highly effective. Moderna CEO Stephane Bancel said in a prepared statement that the vaccine developer pioneered that technology and invested billions of dollars in creating it. The company said it believes its rivals’ vaccine infringes on patents Moderna filed between 2010 and 2016. Moderna said it recognizes the importance of vaccine access and is not seeking to remove Comirnaty from the market. It also is not asking for an injunction to prevent future sales. Moderna said in 2020 that it would not enforce its COVID-19 related patents while the pandemic continued. But the company said in March, with vaccine supplies improving globally, that it would update that pledge. It said it still would not enforce its patients for vaccines used in low- and middle-income countries. But it expected companies like Pfizer and BioNTech to respect its intellectual property, and it would consider “a commercially reasonable license” in other markets if they requested one. “Pfizer and BioNTech have failed to do so,” Moderna said in a statement.

Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults. The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors. In a press release, the company said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities." Also read: Moderna jab will be given as booster doses: DGHS U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to “urgently” approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations. U.S. health officials currently recommend a primary series of two doses of the Moderna vaccine and a booster dose months later. Moderna said its request for an additional dose was based on “recently published data generated in the United States and Israel following the emergence of Omicron.” Also read: Moderna: Initial booster data shows good results on omicron On Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to authorize an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.

Moderna said Monday that a booster dose of its COVID-19 vaccine should offer protection against the rapidly spreading omicron variant. Moderna said lab tests showed the half-dose booster shot increased by 37 times the level of so-called neutralizing antibodies able to fight omicron. And a full-dose booster was even stronger, triggering an 83-fold jump in antibody levels, although with an increase in the usual side effects, the company said. While half-dose shots are being used for most Moderna boosters, a full-dose third shot has been recommended for people with weakened immune systems. Also read: Omicron may sideline two leading drugs against COVID-19 Moderna announced the preliminary laboratory data in a press release and it hasn’t yet undergone scientific review. But testing by the U.S. National Institutes of Health, announced last week by Dr. Anthony Fauci, found a similar jump. Pfizer’s testing likewise found its COVID-19 vaccine triggered a similarly big jump in omicron-fighting antibodies. The vaccines made by Pfizer and by Moderna, both made with mRNA technology, are used by many countries around the world to fight the coronavirus. Also read: WHO: Omicron detected in 89 countries, cases doubling fast

Most Americans should be given the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot that can cause rare but serious blood clots, U.S. health officials said Thursday. The strange clotting problem has caused nine confirmed deaths after J&J vaccinations — while the Pfizer and Moderna vaccines don't come with that risk and also appear more effective, said advisers to the Centers for Disease Control and Prevention. The panel recommended the unusual move of giving preference to the Pfizer and Moderna vaccines, and late Thursday the CDC's director, Dr. Rochelle Walensky, accepted the panel's advice. Until now the U.S. has treated all three COVID-19 vaccines available to Americans as an equal choice, since large studies found they all offered strong protection and early supplies were limited. J&J's vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups like homeless people who might not get the needed second dose of the Pfizer or Moderna options. Also read: Pfizer confirms COVID pill’s results, potency versus omicron But the CDC's advisers said during a meeting Thursday that it was time to recognize a lot has changed since vaccines began rolling out a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who got the J&J shot. New data from unprecedented safety tracking of all those vaccinations persuaded the panel that while the blood clots linked to J&J's vaccine remain very rare, they're still occurring and not just in younger women as originally thought. In a unanimous vote, the advisers decided the safer Pfizer and Moderna vaccines are preferred. But they said the shot made by J&J's Janssen division still should be available if someone really wants it — or has a severe allergy to the other options. “I would not recommend the Janssen vaccine to my family members” but some patients may -- and should be able to -- choose that shot, said CDC adviser Dr. Beth Bell of the University of Washington. The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. Eventually U.S. regulators decided the benefits of J&J's one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned. European regulators likewise continued to recommend AstraZeneca's two-dose vaccine although, because early reports were mostly in younger women, some countries issued age restrictions. COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they're made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea. Also read: US expands Pfizer COVID boosters, opens extra dose to age 16 While it’s still very rare, the Food and Drug Administration told health care providers this week that more cases have occurred after J&J vaccinations since the spring. They occur most in women ages 30 to 49 -- about once for every 100,000 doses administered, the FDA said. Overall, the government has confirmed 54 clot cases— 37 in women and 17 in men, and nine deaths that included two men, the CDC's Dr. Isaac See said Thursday. He said two additional deaths are suspected. The CDC decides how vaccines should be used in the U.S., and its advisers called the continuing deaths troubling. In comparing the pros and cons of all the vaccines, the panelists agreed that side effects from the Pfizer and Moderna vaccines weren't as serious — and that supplies now are plentiful. Nor is J&J still considered a one-and-done vaccine, several advisers noted. The single-dose option didn't prove quite as protective as two doses of the Pfizer and Moderna vaccines. Plus, with extra-contagious virus mutants now spreading, booster doses now are recommended. For J&J recipients, a booster is recommended at least two months after vaccination. U.S. health officials had previously OK’d mixing vaccines for booster shots. Several countries, including Canada, already have policies that give preference to the Pfizer and Moderna vaccines. But J&J told the committee its vaccine still offers strong protection and is a critical option especially in parts of the world without plentiful vaccine supplies or for people who don't want a two-dose shot. While blood clots are rare, “unfortunately cases of COVID-19 are not,” J&J’s Dr. Penny Heaton said. The U.S. is fortunate in its vaccine availability and Thursday's action shouldn't discourage use of J&J's vaccine in places around the world where it's needed, said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado. The FDA also warned this week that another dose of the J&J vaccine shouldn't be given to anyone who developed a clot following either a J&J or AstraZeneca shot. The committee also heard some of the first data on reported side effects of Pfizer vaccinations in younger children. Early last month, the CDC recommended a two-dose series for that age group, and more than 7 million doses have been given so far. But few problems have been reported. Of the 80 reported cases of serious side effects, about 10 involved a form of inflammation that has been seen in male teens and young adults.

U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially. The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when. The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow “mixing and matching” of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination. Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again. For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination. The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines. Also read: J&J seeks US clearance for COVID-19 vaccine booster doses As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time. FDA officials said they wanted to make the booster guidance as flexible as possible, given that many people don’t remember which brand of vaccine they received. “Being able to interchange these vaccines is a good thing — it’s like what we do with flu vaccines,” FDA’s Dr. Peter Marks told reporters Wednesday evening. “Most people don’t know what brand of flu vaccine they received.” Still, he added that many people will decide to get a booster from the same company as their initial vaccination. The agency’s mix-and-match decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. The study didn’t test the half-dose Moderna booster. Also read: Am I fully vaccinated without a COVID-19 vaccine booster? Health authorities stress that the priority still is getting first shots to about 65 million eligible Americans who remain unvaccinated. But the booster campaign is meant to shore up protection against the virus amid signs that vaccine effectiveness is waning against mild infections, even though all three brands continue to protect against hospitalization and death. “Today the currently available data suggest waning immunity in some populations of fully vaccinated people,” said FDA’s acting commissioner Dr. Janet Woodcock. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.” The Moderna booster decision essentially matches FDA’s ruling that high-risk groups are eligible for the Pfizer vaccine, which is made with the same technology. FDA recommended that everyone who’d gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested J&J’s vaccine should have originally been designed to require two doses. Experts continue to debate the rationale of the booster campaign. Some warn that the U.S. government hasn’t clearly articulated the goals of boosters given that the shots continue to head off the worst effects of COVID-19, and wonder if the aim is to tamp down on virus spread by curbing, at least temporarily, milder infections. FDA regulators said they would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted. “We are watching this very closely and will take action as appropriate to make sure that the maximum protection is provided to the population,” said Marks, the FDA’s top vaccine official. In August, the Biden administration announced plans for an across-the-board booster campaign aimed at all U.S. adults, but outside experts have repeatedly argued against such a sweeping effort. On Thursday an influential panel convened by the CDC is expected to offer more specifics on who should get boosters and when. Their recommendations are subject to approval by the CDC director. The vast majority of the nearly 190 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while about 15 million have received the J&J vaccine.

U.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine at least six months ago should get a half-dose booster to rev up protection against the coronavirus. The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19. The recommendation is non-binding but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month — and those are the same high-risk groups that FDA's advisers said should get a Moderna booster. Also read: J&J seeks US clearance for COVID-19 vaccine booster doses But there's no evidence that it's time to open booster doses of either the Moderna or Pfizer vaccine to everybody, the panel stressed — despite initial Biden administration plans to eventually do that. The coronavirus still is mostly a threat to unvaccinated people — while the vaccinated have strong protection against severe illness or death from COVID-19. “I don’t really see a need for a ‘let it rip’ campaign for everyone," said Dr. Michael Kurilla of the National Institutes of Health. As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster. The agency convened its experts to weigh in on who should get boosters and when for those who received the Moderna and Johnson & Johnson shots earlier this year. The panel will discuss J&J on Friday. Also read: Am I fully vaccinated without a COVID-19 vaccine booster? The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one. Many U.S. scientists remain divided about exactly who needs boosters and their purpose — whether they’re needed mostly for people at risk of severe disease or whether they should be used to try to reduce milder infections, too. The FDA panel wrestled with whether Moderna presented enough evidence backing its low-dose booster. As the delta variant surged in July and August, a Moderna study found people who were more recently vaccinated had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago. Another study of 344 people found a six-month booster shot restored virus-fighting antibodies to levels thought to be protective — and that included large jumps in antibodies able to target the delta variant. But that was a small study, and only about half of those people got the exact series of doses that would be offered under a Moderna booster campaign. “The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh. And several advisers worried that boosting with a lower dose might cost people some of the potential benefit of a full-strength third shot. Also read: COVID-19 vaccine boosters could mean billions for drugmakers “That may actually have a tremendous impact on the durability,” Kurilla said. Moderna said it chose the lower-dose booster because it triggered fewer uncomfortable shot reactions such as fever and achiness but also leaves more vaccine available for the global supply. One very rare side effect of both the Moderna and Pfizer vaccines is heart inflammation, particularly among young men soon after the second dose — and one lingering question is whether another dose could spark more cases. Moderna's booster study wasn't large enough to spot such a rare risk. But Israel began offering Pfizer boosters sooner than the U.S. and to more of its population. Thursday, Dr. Sharon Alroy-Preis of Israel's health ministry told the FDA panel that after 3.7 million booster doses administered, there's no sign the extra shot is any riskier. Because the Moderna vaccine is similar, the FDA's advisers found that data reassuring. While Pfizer's boosters are only for certain high-risk groups of Americans, Israeli officials credit wider booster use in their country to stemming the delta surge. “There is no question in my mind that the break of the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers who noted that other countries have seen a lowering of delta cases without widespread booster use. But FDA's advisers also highlighted one confusing issue: People with severely weakened immune systems already can get a third full dose of the Moderna vaccine soon after the initial vaccinations — so a lingering question is whether they should be eligible for a booster, too, which would be their fourth dose.

Moderna has no plans to share the recipe for its COVID-19 vaccine because executives have concluded that scaling up the company's own production is the best way to increase the global supply, the company’s chairman said Monday. In an interview with The Associated Press, Noubar Afeyan also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic. “We didn’t have to do that," Afeyan said. ”We think that was the right, responsible thing to do.” He added: “We want that to be helping the world.” Read:Japan suspends 1.63M doses of Moderna over contamination The United Nations health agency has pressed Moderna to share its vaccine formula. Afeyan said the company analyzed whether it would be better to share the messenger RNA technology and determined that it could expand production and deliver billions of additional doses in 2022. “Within the next six to nine months, the most reliable way to make high-quality vaccines and in an efficient way is going to be if we make them," Afeyan said. Asked about appeals from the World Health Organization and others, he contended that such pleas assumed ”that we couldn’t get enough capacity, but in fact we know we can.” Moderna “went from having zero production to having 1 billion doses in less than a year," Afeyan said, referring to the Massachusetts-based company's sprint to develop the vaccine and produce it in large quantities. "And we think we will be able to go from 1 to 3 billion" in 2022. "We think we are doing everything we can to help this pandemic,'' Afeyan added, citing the company's increasing output and its pledge on patent infringement. He noted that $2.5 billion (about 2.1 billion euros) and 10 years were spent in developing the platform that makes Moderna's COVID-19 vaccine. “Others joined the hunt when COVID-19 came along, and we're glad to see that the capacity therefore has been increased considerably beyond what Moderna would have been able to do” by itself, Afeyan said. Read: Moderna says vaccine 93% effective but seeks 3rd-shot in fall Asked how successful he thought others might be if they started from scratch using Moderna patents, he declined to speculate. But “it's hard for me to imagine that they would be able to get any meaningful scale in a short time frame at the quality we would be able to do as a certainty” for 2022. Asked about recent criticism that Moderna has been furnishing its vaccine mainly to wealthy countries while low-income countries clamor for the product, Afeyan said the company supplied a “quite significant” output to poorer nations, mostly through its work with the U.S. government, which contracted early in the pandemic with the company for doses. Moderna is working with multiple governments "to help them secure supplies for the express purpose of supplying to low-income countries,'' the executive said. “There is more supply in the EU and the U.S. government than they will be able to use,” said Afeyan, who is also a co-founder of Moderna. Read: Close to committing $1 billion to Moderna for Covid-19 booster shot: Cipla Separately, Moderna made a commitment in May to Covax, the U.N.-backed vaccine program, to arrange for a total of 500 million does to go to poorer countries. He said probably 40 million doses would begin to ship in the last three months of this year, with the rest shipping next year. The COVID-19 vaccine is Moderna's only commercial product. The company announced plans last week to open a vaccine plant somewhere in Africa. Afeyan said he hopes a decision will be made soon on an exact location. Still, it could take years to get the plant up and running. Afeyan spoke on the last full day of a visit to Italy in which he met Pope Francis, who has appealed for universal vaccine access. He also appeared in Venice to promote a humanitarian prize. Co-founded by Afeyan, the Aurora Humanitarian Initiative aims to “empower modern-day saviors to offer life and hope” to those urgently needing basic humanitarian aid. Through the prize, the organization has awarded $5 million in grants to more than 30 humanitarian projects to help people recover from war, famine, genocide, human rights violations and other challenges.

Bangladesh will get 71 lakh doses of Pfizer and 18 lakh of Moderna vaccines as part of US donation and regular supply under the COVAX facility. "We've received a new allocation of 71 lakh Pfizer doses (US donation) and 18 lakh Moderna doses (regular COVAX allocation) from COVAX Facility," said State Minister for Foreign Affairs M Shahriar Alam. Read: Dhaka receives 50 lakh more doses of Sinopharm vaccine These vaccine doses will be shipped in the last quarter of this year, Shahriar added. He said they are hopeful of getting more vaccine allocations during the period, and thanked the USA and COVAX for the support.

Those who are aged between 12 and 17 will be brought under the coverage of vaccination against Covid-19 once it is approved by the World Health Organization (WHO), said Health Minister Zahid Maleque on Monday. “We’ve applied to WHO seeking its approval in this regard. The approval of the National Technical Advisory Committee is also needed. Once approved, we’ll start vaccinating those who are aged 12-17,” said the minister while talking to reporters after a meeting at the secretariat. Read: No decision yet on vaccinating the under-18: DGHS

Action will be taken if any Health Department officials are found involved in the recent selling of Covid-19 jabs in Dhaka city and elsewhere in the country, Director General of the Directorate General of Health Services (DGHS) ABM Khurshid Alam warned on Sunday. He said this while talking to UNB during a visit to National Institute of Neurosciences & Hospital in Dhaka. He said vaccine stealing is a sensitive issue and investigation is going on regarding this. Also read: Take actions against Cumilla councilor for pushing Covid jabs: Probe His warning came days after police held Bijoy Krishna Talukdar, owner of ‘Doridro Paribar Seba’ clinic in city’s Dakshinkhan area for illegally administering Moderna Covid-19 jabs.