MODERNA

Parents hoping to get their youngest children vaccinated against COVID-19 have some encouraging news. That news comes a month after Moderna said it would ask regulators to OK its two shot regimen for the youngest kids. (AP Photo/Emma H. Tobin, File) (Emma H. Tobin)Parents hoping to get their youngest children vaccinated against COVID-19 got some encouraging news Monday. That news comes a month after Moderna said it would ask regulators to OK its two doses tor the youngest kids. It’s not clear how much demand there will be to vaccinate the youngest kids, however.

Parents hoping to get their youngest children vaccinated against COVID-19 have some encouraging news.

Pfizer says preliminary data shows its three-dose vaccine regimen is 80% effective in preventing symptomatic COVID-19 in kids 6 months to 4 years old.

Pfizer says preliminary data shows its three-dose vaccine regimen is 80% effective in preventing symptomatic COVID-19 in kids 6 months to 4 years old.

Pfizer and BioNTech said Monday that three doses of their COVID-19 vaccine offer strong protection for children ranging from 6 months old to under 5 years old, The Associated Press is reporting. >> Read more trending newsIn a news release, the drugmakers said preliminary data from a Phase 2/3 clinical trial of 1,678 young children showed that three 3-microgram doses of the vaccine were safe and 80.3% effective in preventing symptomatic COVID-19. Only 10 COVID-19 have been identified so far among study participants; the companies said they won’t perform a formal analysis until researchers log 21 cases, the companies said. We published data indicating that a low dose of 3 µg of our #mRNA COVID-19 vaccine, carefully selected based on tolerability data, is effective and provides children under 5 years of age with a high level of protection against the recent #COVID19 strains. https://t.co/Jv0Jo0Gtyq — Moderna (@moderna_tx) April 28, 2022Check back for more on this developing story.

(AP Photo/Rogelio V. Solis, File) (Rogelio V. Solis)Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday. Pfizer plans to give the data to U.S. regulators later this week in a step toward letting the littlest kids get the shots. FDA vaccine chief Dr. Peter Marks has pledged the agency will “move quickly without sacrificing our standards” in evaluating tot-sized doses from both Pfizer and Moderna. While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that age group have gotten the recommended initial two doses.

The U.S. will have to decide soon whether to bet big on an Omicron vaccine.

The license would help the World Health Organization work with manufacturers around the world to produce their own Covid-19 vaccines.

Novavax reported net income of $203 million in the first quarter, compared to a net loss of $222.7 million the same period last year.

The FDA said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine.

On Thursday, May 5, 2022, U.S. regulators strictly limited who can receive this vaccine due to a rare but serious risk of blood clots. The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine. FDA officials said in a statement that they decided to restrict J&J's vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination. J&J’s vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. And while the blood clots seen with J&J's shot are rare, officials say they're still occurring.

U.S. regulators are strictly limiting who can receive Johnson & Johnson’s COVID-19 vaccine due to a rare but serious risk of blood clots.

COVID-19 vaccine sales helped Moderna triple its net income in a better-than-expected first quarter. (AP Photo/Ted S. Warren, File) (Ted S. Warren)COVID-19 vaccine sales helped Moderna triple its net income in a better-than-expected first quarter. In the first quarter, Moderna earned $3.7 billion, compared with $1.2 billion in the same period last year. While vaccine sales jumped compared to last year, they slid $1 billion from the fourth quarter of 2021, when customers sought boosters and many children began getting shots. Moderna also said Wednesday that it has signed purchase agreements for about $21 billion in sales for 2022.

Earns Moderna FILE - In this March 4, 2021 file photo, a vial of the Moderna COVID-19 vaccine rests on a table at a drive-up mass vaccination site in Puyallup, Wash., south of Seattle. COVID-19 vaccine sales helped Moderna triple its net income in a better-than-expected first quarter. — (AP) — COVID-19 vaccine sales helped Moderna triple its net income in a better-than-expected first quarter. In the first quarter, Moderna earned $3.7 billion, compared with $1.2 billion in the same period last year. Moderna now has about 3,200 full-time workers, more than twice the total employed at the end of last year’s quarter.

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Sales of Pfizer’s COVID-19 vaccine and treatment pushed the drugmaker well past expectations in the first quarter, as profit grew 61%. (AP Photo/Mark Lennihan) (Mark Lennihan)Pfizer now hopes to tell U.S. regulators how well its COVID-19 vaccine works in the littlest kids by late May or early June. Pfizer is testing three extra-small doses of its vaccine in children under 5 after two shots didn't prove quite strong enough. Currently in the U.S., only children ages 5 or older can be vaccinated, using Pfizer’s vaccine -- leaving 18 million younger tots unprotected. Last week, it filed with the Food and Drug Administration data it hopes will prove two of its low-dose shots work in children younger than 5.

Pfizer now hopes to tell U.S. regulators how well its COVID-19 vaccine works in the littlest kids by early June.

Omicron XE COVID-19 variant: What you need to know (NCD)Moderna is “confident” that it will be able to provide a vaccine booster against both omicron and other variants of the COVID-19 virus, the company’s top medical officer said Sunday. Last month the company said that the booster is more effective against coronavirus variants than its current version of the vaccine. Moderna sought emergency use authorization from the FDA for the drug on Thursday. “I think the FDA now have all of the core fundamental data they need to be able to begin an application review. So yes, we’re very confident,” Burton said.

The biotech Arcturus has shown how new self-copying mRNA technology could get many people vaccinated quickly.

The following is a transcript of an interview with Dr. Paul Burton, chief medical officer at Moderna, that aired Sunday, May 1, 2022, on "Face the Nation."

Moderna seeks authorization for COVID-19 vaccine for young children Moderna seeks authorization for COVID-19 vaccine for young children (NCD)The Food and Drug Administration has scheduled meetings in June to discuss the latest COVID-19 vaccine guidance, including discussing the newest vaccines that could be used on the country’s youngest children. The panel will discuss emergency use authorization requests from Moderna and Pfizer/BioNTech for coronavirus vaccines meant for children under the age of 6. “The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. >>Related: Coronavirus: Moderna seeks FDA approval of COVID-19 vaccine for kids younger than 6Normally the FDA waits until the committee makes a decision before giving a final ruling, but usually follows the VRBPAC recommendation. Moderna asked the FDA for an EUA for its lower dose COVID-19 vaccine that is designed for children between the ages of 6 months to 5 years, NBC News reported.

The meetings are a sign that the vaccines are moving closer to a possible authorization.

Virus Outbreak Vaccines Kids FILE - A nursing student administers a Moderna COVID-19 vaccine at a vaccination center at UNLV, in Las Vegas on April 26, 2021. The dates are not final and the FDA said it will provide additional details as each company completes their application. On Thursday, Moderna submitted data to the FDA that it hopes will prove its two low-dose shots can protect children younger than 6. Moderna has filed FDA applications for older kids, but the FDA hasn’t ruled on them. It’s not clear if that data for older children will be considered at the June meetings.

The Food and Drug Administration has set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children.

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Moderna on Thursday submitted a request to the Food and Drug Administration for emergency authorization of its COVID-19 vaccine for children younger than 6, a welcome development for parents.

Moderna is asking U.S. regulators to approve its COVID-19 vaccine for kids under 5 — the only group not yet eligible for vaccination.

The trials were primarily conducted during COVID's Omicron​ wave.

The trials were primarily conducted during COVID's Omicron​ wave.

More children across the U.S. may soon be able to get a COVID-19 vaccine.

Moderna is asking U.S. regulators to open its COVID-19 vaccine to the nation's youngest children.

The company says a low-dose version of its vaccine triggers an immune response in children ages 6 months to less than 6 years equivalent to what has protected older children and adults.

ORLANDO, Fla. — Dr. Anthony Fauci said COVID-19 shots for kids under 5 could be available by June. He’s said he’s expecting both Moderna and Pfizer to submit their vaccines for children aged 6 months to 5 years old very soon. Fauci said the FDA could delay its rulings until both vaccines are ready to go, out of an abundance of caution. READ: Coronavirus: FDA authorizes first COVID-19 breath testFauci says that another reason for the delay is that don’t want to confuse parents. Releasing both vaccines at the same time would make things simpler too.

ORLANDO, Fla. — Dr. Anthony Fauci said COVID-19 shots for kids under 5 could be available by June. He’s said he’s expecting both Moderna and Pfizer to submit their vaccines for children aged 6 months to 5 years old very soon. Fauci said the FDA could delay its rulings until both vaccines are ready to go, out of an abundance of caution. READ: Coronavirus: FDA authorizes first COVID-19 breath testFauci says that another reason for the delay is that don’t want to confuse parents. Releasing both vaccines at the same time would make things simpler too.

Virus Outbreak Moderna FILE - Syringes and a vial of the Moderna COVID-19 vaccine are displayed at a mass COVID-19 vaccination site in Batavia, Ill., on March 19, 2021. The DOJ seized over $8 million in cash and other fraud proceeds. “The Department of Justice is committed to protecting the American people and the critical health care benefits programs that assist them during this national emergency. The tests were ineligible for reimbursement and procured through kickbacks and bribes, and Shams and Navarro concealed their roles in the lab because of prior health care fraud convictions, according to the indictment. The Justice Department named a chief prosecutor for pandemic fraud last month, Kevin Chambers, following through on President Joe Biden's State of the Union promise to go after criminals who stole billions in relief money.

The company says this version targets both the original coronavirus and the beta variant, and appears to provide broader and longer-lasting protection against different strains, including omicron.

Moderna's goal is to produce a combination shot that specifically targets Omicron.

Moderna hopes to offer updated COVID-19 boosters in the fall that combine its original vaccine with protection against the omicron variant. But the virus continues to mutate, with the super-contagious omicron variant — and its siblings — the latest threat. While the antibody increase was modest, Moderna's goal is to produce a combination shot that specifically targets omicron. So Moderna and its rival Pfizer both are testing what scientists call “bivalent” shots — a mix of each company's original vaccine and an omicron-targeted version. Now Moderna is testing a bivalent shot that better targets omicron — it includes 32 of that variant's mutations.

Moderna hopes to offer updated COVID-19 boosters in the fall that combine the original vaccine with protection against the latest variant.

The jab, seen as an alternative for people who are vaccine-hesitant, is widely available in the EU but still not cleared for use in the UK.

Additional booster shot FILE PHOTO: The FDA has authorized an additional COVID-19 booster shot. (Teka77/Getty Images/iStockphoto)ORLANDO, Fla. — Southeastern Grocers announced that it is now administering additional Pfizer or Moderna booster shots to anyone over 12 who is immunocompromised and anyone age 50 and older. These groups can get their second booster shot four months after their first booster shot to further increase protection. READ: CDC recommends additional COVID-19 booster shot for certain peopleThose who received a Johnson & Johnson vaccine and booster at least four months ago may also receive a second booster dose of Pfizer or Moderna’s shot. The shots will be available at Fresco y Más, Harveys Supermarket and Winn-Dixie pharmacies.

Eligible individuals can either schedule appointments online or walk into pharmacies for same-day jabs.

WHO IS ELIGIBLE FOR A SECOND BOOSTER? A new study found a Moderna or Pfizer second shot was superior to getting a second J&J dose. So the advice is anyone who got a second J&J shot now can choose a Moderna or Pfizer dose. Israel began offering people 60 and older a second booster during its omicron surge. WHO REALLY NEEDS A SECOND BOOSTER?

Many Americans can now get a second COVID-19 booster, but it’s hard to tell who really needs another shot right now and who could wait.

Democrats are trying to pass more COVID-19 funding after Republicans demanded it be cut out of a larger spending bill.

J&J vaccine with mRNA booster The Centers for Disease Control and Prevention has recommended that those who receive one or two shots of the Johnson & Johnson COVID-19 vaccine follow up with a booster of an mRNA vaccine from Pfizer-BioNTech or Moderna. The study from the CDC that analyzed the results of mix-and-match vaccine-and-booster combinations showed that combining the J&J vaccine with one of the mRNA vaccines provided much stronger protection against severe COVID-19 symptoms than did the one-dose J&J shot with a J&J booster. · Two J&J shots offered 54% effectiveness. · A combination of J&J shot(s) with one mRNA booster offered 79% effectiveness. · Three mRNA shots offered 83% effectiveness.

“They are the most likely to benefit from receiving an additional booster dose at this time,” Walensky said. The move toward additional boosters comes at a time of great uncertainty, with limited evidence to tell how much benefit an extra dose right now could offer. Until now, the FDA had allowed a fourth vaccine dose only for the immune-compromised as young as 12. Only the Pfizer vaccine can be used in those as young as 12; Moderna's is for adults. If the new recommendations sound confusing, outside experts say it makes sense to consider extra protection for the most vulnerable.

After a stellar run in adult and teen trials, the vaccines are now trying to contend with Omicron, and the numbers show it.

U.S. regulators authorized a fourth shot of the Pfizer or Moderna vaccines for people 50 and older at least four months after their previous booster.

U.S. regulators authorized a fourth shot of the Pfizer or Moderna vaccines for people 50 and older at least four months after their previous booster.

The Food and Drug Administration has authorized another booster dose of the Pfizer or Moderna COVID-19 vaccine for people age 50 and up, Tuesday, March 29, 2022. The Food and Drug Administration's decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster. Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot. Two vaccine doses plus a booster still provide strong protection against severe disease and death, CDC data show.

Americans age 50 and older can get a second COVID-19 booster if it’s been at least four months since their last vaccination.

The FDA made the decision comes without consulting its committee of independent vaccine experts.

>> Read more trending newsThe Post cited several unnamed government officials, who said the authorization could be announced as soon as Tuesday. The director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, is expected to sign off on the FDA decision, according to the unnamed officials. People over 50 will be eligible to get the second booster at least four months after receiving the first booster. The second booster has already been recommended for people whose immune systems are compromised. According to the Post, FDA officials favored a second booster for older people because of concerns about the spread of the omicron BA.2 subvariant.

"You have people that are younger adults that have comorbidity factors, and they might need [a] sooner fourth dose to protect them," CEO Stephane Bancel told CNBC.

Virus Outbreak Moderna Kids Ilana Diener plays with her son, Hudson, 3, at home in Commack, N.Y. on Nov. 30, 2021, before an appointment for a Moderna COVID-19 vaccine trial. Moderna intends to seek U.S. authorization for kid-sized shots, releasing early study results Wednesday that suggest the two small doses work in tots younger than 6. Full study results are yet to come but the early findings suggest the vaccine may protect against severe illness in kids just like it does in adults. WHAT ABOUT MODERNA SHOTS FOR OLDER KIDS? The FDA limits Moderna's vaccine to adults although it's used in kids as young as 6 in certain other countries.

Moderna says it will ask regulators to authorize its COVID-19 vaccine for children under 6 but several hurdles need to be cleared before the shots could become available.

Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6.

Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6.

Moderna says its COVID-19 vaccine works in babies, toddlers and preschoolers.

Drugmaker Moderna has asked the Food and Drug Administration to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults.

Moderna says it has signed a memorandum of understanding with Kenya’s government for the drugmaker's first mRNA vaccine manufacturing facility in Africa.

Moderna’s COVID-19 vaccine brought in nearly $7 billion in the final quarter of 2021, and the drugmaker says it has signed purchase agreements for another $19 billion in sales this year.

The World Health Organization is creating a global training center to help poorer countries make vaccines, antibodies and cancer treatments using the messenger RNA technology used to make COVID-19 vaccines.

Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia will be the first African countries to receive the technology required to produce mRNA vaccines on the continent.

The Centers for Disease Control and Prevention has continued its endorsement of Moderna’s COVID-19 vaccine for U.S. adults.

Tokyo has launched a mass inoculation drive for COVID-19 booster shots at a temporary center operated by the military as Japan tries to speed up delayed third jabs to counter surging infections.

Moderna has begun testing an omicron-specific version of its COVID-19 vaccine in healthy adults.

Haiti's health minister says the country is fighting a rise in COVID-19 cases as the government struggles to convince people to get vaccinated.

U.S. officials are loosening rules that call on health care workers to stay out of work for 10 days if they test positive for COVID-19.

Moderna said Monday that a booster dose of its COVID-19 vaccine should offer protection against the rapidly spreading omicron variant.

U.S. health officials say most Americans should get the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot.

Vaccine makers are racing to update their COVID-19 shots against omicron even before it’s clear a change is needed, just in case.

Asian shares are mixed as investors continue to cautiously weigh how much damage the new omicron coronavirus variant may unleash on the global economy.

The drugmaker filed for authorization with the Food and Drug Administration last week, and so did Moderna. Both pharmaceuticals would still need the CDC to sign-off to begin distributing the booster shots.

The NBA has told its players, coaches and referees that they should receive booster shots against the coronavirus, with particular urgency for those who received the single-dose Johnson & Johnson vaccine.

Moderna is scaling back expectations for the number of COVID-19 vaccine deliveries it expects to make this year and the revenue it will record from them.

U.S. regulators are delaying their decision on Moderna’s COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation.

Moderna says it will make up to 110 million doses of its COVID-19 vaccine available to African countries.

Moderna says its low-dose COVID-19 vaccine is safe and appears to work in 6- to 11-year-olds.

A team of young scientists in South Africa is assembling the equipment needed to reverse engineer Moderna's coronavirus vaccine.

Orange County is prepared to offer three COVID-19 booster shot options at the Barnett Park vaccination site, according to county officials.

Millions more Americans are now eligible for COVID-19 boosters, and they can get a different vaccine than their first shots.

Federal health officials say millions more Americans can get a COVID-19 booster and choose a different vaccine for that next shot.

U.S. regulators are extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine.

Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week.

COVID-19 booster shots are an extra dose of the original vaccine, and some experts wonder why they weren't updated to better match the delta variant.

The Food and Drug Administration panel endorsed Johnson & Johnson’s COVID-19 vaccine booster Friday, a day after they recommended a half-dose booster shot of the Moderna vaccine.

A top U.S. trade official says the Biden administration remains committed to an easing of rules that protect the technology behind coronavirus vaccines so that they can be produced more widely.

A panel of U.S. health advisers has endorsed booster shots for Moderna’s COVID-19 vaccine.

With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn.

The chairman of Moderna says the company has no plans to share the recipe for its COVID-19 vaccine because executives have concluded that scaling up their own production is the best way to increase the global supply.

The United Nations chief says the pandemic has forced more than 100 million people into poverty and left over 4 billion people with little or no social support, health care or income protection.

Pfizer is asking the U.S. government to allow use of its COVID-19 vaccine in children ages 5 to 11.

Scandinavian authorities have suspended or discouraged the use of Moderna’s COVID-19 vaccine in young people because of an increased risk of heart inflammation, a very rare side effect associated with the shot.

The European Union’s drug regulator has given its backing to booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older.

In a story published September 27, 2021, about vaccine mandates for health care workers, The Associated Press erroneously reported that Dr. Jeff Smith was the CEO of Cedars-Sinai Medical Center.

Millions of Americans are now eligible to receive a Pfizer booster shot to help increase their protection against the worst effects of the coronavirus.

Vietnam is speeding up its vaccination program in an effort to loosen coronavirus lockdown restrictions in major cities by the end of the month.