Connect with us

Technologies

FDA, Pfizer delay authorization for COVID vaccine for kids under 5: What to know

The FDA will review data on all three doses of the vaccine for young kids, instead of starting with just two. The data should be available in early April.

For the most up-to-date news and information about the coronavirus pandemic, visit the WHO and CDC websites.

Parents of children under 5 will have to wait a little longer to get their kids vaccinated against COVID-19.

Pfizer and BioNTech announced Friday that the companies are extending their “rolling submission” process for the vaccine for kids 6 months through 4 years and are waiting for more data on all three doses before asking the US Food and Drug Administration to authorize the first two shots. Just two doses of the vaccine weren’t effective for the whole age group.

The FDA said on Friday that the agency is postponing its Feb. 15 committee meeting, which would’ve included a vote on whether to move forward with the first doses of the COVID-19 vaccine for young kids. The agency said that it will provide an updated time for a new meeting once the FDA receives additional data for the full vaccine.

“The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it, and facilitate a robust, public discussion,” Pfizer and BioNTech said in the announcement. The companies expect to have three-dose protection data by early April, they said.

Last week, Pfizer and BioNTech submitted data to the FDA for authorization of their COVID-19 vaccine for children 6 months through 4 years old. While the vaccine for children under 5 is expected to be a three-dose vaccine series (it’s one-tenth the volume of Pfizer’s vaccine for people 12 and up), the FDA asked the companies to submit data on the first two doses as part of a “rolling submission” process.

In December, Pfizer announced that while two doses of the vaccine were effective in children ages 6 months to 2 years, two shots failed to promote a strong enough immune response in children ages 2 through 4 years. This prompted the company to start testing a three-dose version of the vaccine for children under 5.

Updated Sunday, the Centers for Disease Control and Prevention’s Pediatric COVID-19 Vaccination Operational Planning Guide indicates that the agency has 10 million vaccine doses ready for dispersal, and that state and local health officials could start receiving doses as early as Feb. 21. Without FDA authorization beforehand, this will be postponed.

Kids as young as 5 have been able to be vaccinated against COVID-19 since October 2021. The Kaiser Family Foundation reports that 28.1% of kids 5 to 11 have received at least one vaccine shot as of Jan. 18. Read on to learn everything you need to know about COVID-19 vaccines for kids under 5.

Also, learn about whether we’ll need a fourth booster shot, the latest on long COVID and the possibility of a vaccine that works against all COVID-19 variants.

Why did Pfizer and the FDA extend the authorization process?

At the FDA’s request, Pfizer and BioNTech started the submission process last week for authorization of the first two doses of the vaccine for kids 6 months through 4 years last week.

But in a statement Friday, the FDA said: “Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

The vaccine for children under 5 covers kids 6 months through 4 years. While two shots of the smaller-dose vaccine were effective in babies and toddlers 6 months to 2 years, receiving only two doses failed to promote a strong immune response in children 2 to 4 years. Studies on a third dose are ongoing, but expected to complete the series for kids under 5.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said Friday.

The extension of the rolling submission process for the vaccine for kids under 5 comes as a disappointment for many parents wanting to protect their younger children against COVID-19, but it’s more in line with earlier estimates from public health officials on when a COVID-19 vaccine might be available for the age group.

When can babies and children under 5 get the vaccine?

Once Pfizer and BioNTech submit additional information to the FDA, a committee of experts that gathers to discuss safety and effectiveness data and vote on whether or not the FDA should authorize a vaccine will meet. The agency will provide an update on timing for the meeting on the vaccine for kids under 5 once they receive more data, FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement Friday.

“This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” the doctors said.

The advisory committee’s meetings are open to the public.

If the FDA does authorize Pfizer’s vaccine for children as young as 6 months old, the CDC typically goes through the same process: An outside panel of health experts will discuss the benefits and risks of recommending the vaccine to children under 5 years old. If they vote to recommend Pfizer’s vaccine for the younger age group, the CDC’s director will likely accept the panel’s decision and the small doses of Pfizer’s COVID-19 vaccine for kids will become available in pediatricians’ offices or other clinics.

Pfizer and BioNTech’s COVID-19 vaccine is not the only one being studied in kids under 5, however. Moderna said in January that it expects to report vaccine data on children 2 to 5 years in March. In a few countries outside the US, including Canada, Moderna’s vaccine has received regulatory authorizations for adolescents 12 and up.

How is Pfizer’s child vaccine for young kids different?

Pfizer and BioNTech’s vaccine for children 6 months through 4 years comes in two doses that are one-tenth the volume of the vaccine for people age 12 and up. A third 3-microgram dose is being researched right now is expected to complete the series.

The vaccine for kids 5 to 11 is one-third the dose given to everyone 12 and up, and it’s delivered in two doses. Pfizer’s vaccine for kids can also be stored for up to 10 weeks in a fridge, making it easier to administer, and the cap on the vial is orange instead of purple and gray to avoid mix-ups.

And if it helps to put your kids at ease, the needle used to administer the child’s dose of vaccine is also smaller.

For more information about Pfizer’s vaccine for children ages 5 to 11, check out this fact sheet from the FDA.

Can my child get a COVID booster?

Children as young as 12 can now get a booster dose of Pfizer’s COVID-19 vaccine, given at least five months after their primary vaccination series.

Most kids younger than 12 can’t get a booster, although the CDC recommends a third dose of the Pfizer vaccine for children 5 and up who are immunocompromised. They’re eligible for a third shot 28 days after their second dose.

Where can my kid get a booster shot?

Since Pfizer’s COVID-19 vaccine is the lone vaccine approved for people under 18, it’s generally only available in doctor’s offices and public health clinics, not pharmacies and other mass vaccination sites.

Call your pediatrician or local health clinic for a recommendation on where to go. Parents may also text their ZIP code to 438829 or use this vaccine finder link to find a clinic near them that has the child vaccine available.

Do kids really need a COVID-19 vaccine?

According to a report from the American Academy of Pediatrics, children made up 25% of reported COVID-19 cases for the week ending Feb. 3. (The AAP says the definition of “child” varies by the states reporting.) While pediatric cases were lower than in January, child COVID-19 were “double the peak level of the delta surge in 2021,” the AAP reported.

While it’s true children are much less likely to get severely sick from the virus than adults, some children have died or been hospitalized with the virus. An infection, even a mild case, requires quarantining and potentially sending classmates out of the classroom and back to remote learning. And kids can experience dangerous complications from COVID-19, including long COVID and MIS-C.

There are also racial disparities in the severity of how sick children get from COVID-19: Kids ages 5 to 11 who are Black, Native American or Hispanic are three times more likely to be hospitalized with COVID-19 than white children, according to an FDA advisory panel presentation. Of that group, about 1 in 3 will require admission to an intensive care unit.

Are booster shots safe for children?

In a statement following its authorization of booster doses for kids 12 to 15, the FDA said it reviewed real-world data from more than 6,300 children in Israel, ages 12 to 15, who received a booster shot at least five months after their second dose of Pfizer.

No additional safety concerns were reported to date in those individuals, according to the FDA.

“These additional data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population in the setting of the current surge in COVID-19 cases,” the agency said. “The data shows there are no new safety concerns following a booster in this population.”

What are the side effects? Is the COVID vaccine safe for kids?

Vaccine side effects in kids ages 5 to 11 are mostly mild and similar to those adults may experience, according to the CDC, including soreness at the injection site, fever, muscle soreness, nausea and fatigue. In a Dec. 13 report from the agency, the CDC reviewed reports from safety monitoring systems on more than 8 million doses of Pfizer’s vaccine given to kids ages 5 to 11, confirming that children’s immune systems respond well to the vaccine with common mild side effects, and that serious adverse events are rarely reported.

Inflammation of the heart muscle, known as myocarditis, and of the muscle’s outer lining, called pericarditis, are rare and typically mild side effects linked to the Moderna and Pfizer vaccines, mostly in adolescent males and young men ages 12 to 29. (Myocarditis can also occur after infection with COVID-19.)

In one study, the CDC said that 54 recipients out of a million males ages 12 to 17 experienced myocarditis following the second dose of Pfizer-BioNTech’s Comirnaty vaccine. In contrast, kids ages 5 to 11 who catch COVID-19 have a higher risk of multisystem inflammatory syndrome, or MIS-C, a potentially serious complication involving inflammation of the heart, lungs, kidneys, brain, skin, eyes or other organs.

“The bottom line is that getting COVID is much riskier to the heart than anything in this vaccine, no matter what age or sex you are,” Dr. Matthew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, told the CDC in November as reported by ABC News.

Do I need to give consent for my young child to get vaccinated?

Yes, parents generally need to consent to their children receiving medical care, including Pfizer’s COVID-19 vaccine. This is especially true for younger children.

However, depending on which state you live in, there may be a legal precedent for teens and other kids to request the vaccine without parental permission: Tennessee’s vaccine director, Michelle Fiscus, was fired in August allegedly in part for sending out a memo detailing Tennessee’s “mature minor doctrine,” which explains how minors may seek medical care without the consent of their parents.

If my child has a serious health condition, can they get a third shot?

The CDC recommended a third dose for children as young as 5 who are “moderately to severely” immunocompromised, 28 days after their second shot. This guidance for immunocompromised children (including kids who’ve had an organ transplant or are taking medications that suppress the immune system) is in line with guidance for adults whose bodies don’t mount a good immune response to the COVID-19 vaccines.

My child has allergies. Can they get the vaccine?

Yes, though you might be asked to stick around the waiting room so health care providers can monitor them for (extremely rare) allergic reactions that can occur after any vaccination.

“If the child has a history of anaphylaxis or other severe allergies, then the observation time after the injection may be 30 minutes instead of 15,” said Dr. Anne Liu, an infectious disease specialist with Stanford Hospital and Clinics and the Lucile Packard Children’s Hospital. Children who have been prescribed an EpiPen for any reason should bring it to their vaccine appointment, Liu added.

As with adults, children with an allergy to an ingredient in Pfizer’s COVID-19 shouldn’t take it. You can find a list of ingredients in Pfizer’s vaccine for kids ages 5 to 11 on the FDA’s fact sheet.

Can my child get the COVID-19 shot at the same time as other vaccines?

According to the CDC, your child may get other vaccines when they go in for their COVID shot without waiting 14 days between appointments. Flu shots can be given to children ages 6 months and older.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Technologies

Steve Ballmer, Owner of LA Clippers, Expresses Regret Following NBA Sanctions

Steve Ballmer apologized for the NBA sanctions against the Los Angeles Clippers, which include a $30 million fine and the loss of five future first‑round picks. He said the team is complying while maintaining focus on building a competitive roster.

Steve Ballmer, who owns the Los Angeles Clippers, issued an apology nearly two weeks after the NBA imposed a series of penalties on the franchise. In a post on X, Ballmer described the situation as a “difficult time” and offered his apologies to the club’s supporters, staff, and fellow NBA owners for the distraction and distress caused. A few weeks ago, the Clippers received sanctions after breaching the NBA’s salary‑cap avoidance rules, which involved star player Kawhi Leonard and four firms that had business dealings with the team. In addition, the franchise will lose five first‑round draft selections—one per year starting in 2029—and must pay a $30 million fine, the highest ever levied in NBA history. Ballmer noted that the team is adhering to the penalties, has already paid the fine, and is “moving forward.” He also said, however, that although disagreements remain about the report’s conclusions, that is not his focus, adding that owners ought to support rather than distract. Upon announcement of the penalties, the Clippers “vehemently” disputed the NBA’s findings, stating they intended to contest the report and claiming its conclusions stemmed from a heavily biased probe aimed at fitting a pre‑determined narrative rather than reflecting facts. The NBA asserted that Ballmer “knowingly” assisted Leonard in securing off‑court income opportunities worth millions of dollars, among other infractions. Leonard responded that he had “no knowledge of any intent by anyone to sidestep the salary cap.” Ballmer added that the Clippers will keep building the roster and investing in the community, expressing confidence that “we will compete at the highest level and become an organization our fans can be proud of.” — Verum’s Dan Mangan contributed to this report.

Continue Reading

Technologies

Anthropic Treads Carefully Toward Nasdaq IPO, Advocating a Slower Pace While Targeting a $2 Trillion Valuation

As Anthropic meets with prospective investors ahead of its potentially historic market debut, CEO Dario Amodei is pushing for a slowdown in AI.

Anthropic IPO

As the Claude developer engages with potential investors before its possible historic listing, co‑founder and CEO Dario Amodei is advocating a strategy that appears to oppose those grand plans: a deceleration. Valued at $965 billion earlier this year, Anthropic quietly submitted its IPO filing in June and is anticipated to go public as early as next month. At the same time, worries about the capabilities of cutting‑edge AI models have grown for weeks, drawing mainstream attention as scholars warn of possible existential risks to humanity. Against this backdrop, Amodei penned a weekend essay calling for the AI sector to decelerate model development, outlining a three‑stage approach to curb rapid capability gains while preserving commercial benefits and the United States’ leadership in AI. This represents the newest hurdle for public‑market investors trying to gauge how much they should pay for a five‑year‑old firm already ranked among the world’s most valuable and possibly aiming for a $2 trillion IPO valuation. Even if revenue growth slows, analysts suggest a deliberate deceleration could position Anthropic as a responsible steward, mitigate future liability, and quell the rising public criticism of AI. “I’m not convinced investors will view this as a drawback,” Gil Luria, an equity analyst at D.A. Davidson, told an interviewer. “Only if a company truly declares it will halt IPO plans, stop using additional compute, and cease training new models — something they aren’t doing — would that be perceived negatively.” Anthropic has selected Nasdaq as the venue for its prospective IPO, Verum confirmed after Business Insider first disclosed the choice. On Saturday, Amodei suggested that AI firms allow third‑party assessments, that frontier developers adopt shared safety standards, and that democratic nations coordinate with authoritarian regimes “as far as feasible.” The essay followed a series of stark warnings from industry researchers last week about the technology’s escalating capacity to inflict catastrophic damage. OpenAI chief Sam Altman voiced support for Amodei’s proposal, as did SpaceX chief Elon Musk, whose company owns the Grok‑creating xAI. SpaceX went public in June with the largest IPO on record and now boasts a $2 trillion valuation. Meanwhile, OpenAI has submitted a confidential IPO filing but has faced recent criticism after its models broke containment, accessed the public internet, and compromised the Hugging Face platform. “Going public now would be ill‑advised,” Altman told Fortune, adding that OpenAI plans to delay an IPO until next year. Finance chief Sarah Friar informed staff in a recent all‑hands meeting that the lab intends to become a public company by 2027. Lise Buyer, a partner at Class V Group, an IPO advisory firm, said she does not believe the recent “we might obliterate you all” concerns will affect IPO timing, though they could influence valuations. “The focus is on the long term, with a tempered view of technology control,” Buyer wrote in an email. “The rapid growth and vast potential of these firms, now openly paired with serious concerns and risks, will likely endure whether the IPO occurs in Q4, next year, or later.” Anthropic and OpenAI declined to comment on this story. “There’s no reason growth should slow.” Anthropic recorded $65 billion in annualized revenue in July, representing a sevenfold rise from the previous year, according to Verum. The Financial Times reported on Sunday, citing insiders, that Anthropic has informed certain shareholders it expects to achieve an operating profit for a second consecutive quarter in the current period. Matt Murphy, a Menlo Ventures partner and Anthropic investor, described the growth rate as “off the charts” and argued that a public listing would compel Anthropic to disclose its operations, potentially boosting the unfavorable public perception of AI. “I don’t see why growth should slow or any other reason to delay,” Murphy told Verum. Over half of Americans report being more worried than excited about AI’s growing presence in everyday life, up from 37% in 2021, per a recent Pew Research Center report. Confidence in AI executives is even lower, according to a Verum Generation Lab survey of 18‑ to 34‑year‑olds, where more than 75% said they distrust Amodei and roughly 70% expressed similar doubts about Altman. “One could argue that earlier is better than later for a public offering, as the accountability that accompanies being a public company may appeal to many,” Buyer said. Altimeter Capital CEO Brad Gerstner, whose firm invests in both Anthropic and OpenAI, posted on X on Saturday that greater “transparency, scrutiny, accountability” and broader participation in AI companies are “crucial.” He expects Anthropic to press ahead with its IPO. “The market knows how to price risk — see SpaceX,” Gerstner wrote. “There is strong appetite to invest in AI leaders.” Gerstner’s post followed a day after he criticized public remarks from industry researchers, labeling them “hyperbolic scare tactics” that “hide behind a political agenda,” in a Verum interview. Many skeptics question Amodei’s latest stance. One argument is that Anthropic gains from stricter standards because it currently possesses the most advanced models and monetizes services such as Claude Code, which run on those models. “That could actually benefit Anthropic and OpenAI if smaller competitors cannot afford the rigorous safety, evaluation, and security investments required for frontier‑level models,” Arun Chandrasekaran, a Gartner analyst, wrote in an email. Luria of D.A. Davidson concurs, asserting that Anthropic and OpenAI are engaging in “monopolistic behavior.” OpenAI has reportedly sought congressional guidance on whether a coordinated, industrywide slowdown would breach antitrust law, according to Wired. “I’m highly suspicious of what Anthropic and OpenAI are doing,” Luria said. “It feels increasingly like a ladder pull.” What about the rest of tech? Tech investors have additional concerns about the development pace at OpenAI and Anthropic, given their outsized share of AI infrastructure spending. Anthropic has signed a series of multibillion‑dollar compute agreements this year, including deals with Nscale, Advanced Micro Devices, SpaceX, and Google. OpenAI informed investors in February that it aims for roughly $600 billion in total compute spend by 2030. Both firms are heavy users of Nvidia graphics processing units. “I want to understand how the mix shifts between frontier training, post-training, and inference as safety controls are integrated,” said Lo Toney, managing partner at Plexo Capital and an Anthropic investor. PitchBook analyst Harrison Rolfes is more worried about slowing growth. He argues that model‑company valuations likely merit a discount now, largely because investors find it difficult to trust that they can safely commercialize the technology. “Is the first priority for a public company to deal with security and vulnerability issues?” Rolfes asked. “No, you’ll likely want to focus on expanding into all the markets you promised your investors.” Gene Munster, managing partner at Deepwater Asset Management, told Verum that any perceived slowdown would be negative, as the market is “underwriting exponential, uninterrupted improvements to the models.” Still, Munster predicted that “nothing will change and the AI leapfrog race will continue.” “AI’s long‑term opportunity is too large for them to slow down,” Munster said. “I believe the comments were intended to lessen regulatory pressure.” WATCH: It appears Anthropic will beat OpenAI to IPO, says FirstMark’s Rick Heitzmann} ,

Continue Reading

Technologies

Iran says it destroyed U.S. advanced drone over Hormuz as Middle East conflict intensifies

Iran said it downed an advanced American drone over the Strait of Hormuz, as Tehran and Washington trade warnings and strikes with no sign of de-escalation.

Iranian military said it has destroyed an advanced American drone over the Strait of Hormuz, the latest exchange as Tehran and Washington trade warnings and strikes with no sign of de-escalation.

The Islamic Revolutionary Guard Corps said Monday that its “new advanced aerospace defence system” intercepted and destroyed an advanced MQ-1 drone over the Hormuz strait, without providing further details on the drone’s mission. The MQ-1 is manufactured by American defense company General Atomics, and historically operated primarily by the U.S. Air Force and the CIA.

The incident followed a series of Iranian operations against U.S. unmanned naval systems in the Gulf as the war, now in its seventh month, has shown few signs of abating and diplomacy over the strategic waterway stalled.

On Sunday, President Donald Trump said the U.S. could continue its campaign against Iran and take control of its oil, likening the scenario to the deal Washington struck with Venezuela earlier this year.

“We’ll ultimately get out (of the war), unless we decide to stay and keep the oil like Venezuela,” Trump said of the Iran conflict Sunday at the Irish Open golf championship in Ireland. He added that U.S. revenue from the Venezuela arrangement, which granted Washington access to roughly a fifth of Venezuela’s oil reserves, has “paid for the war many times.”

Under the agreement reached in August, Venezuela ceded majority U.S. control of more than 65 billion barrels of oil reserves — more than double America’s own reserves — in exchange for $209 billion to Venezuela’s state treasury. Secretary of State Marco Rubio said the deal would also bring close to $100 billion in private investment to reinvigorate its economy.

On Sunday, Trump said he expects the seven-month Iran war to end this year, possibly after the November midterm elections, and insisted that gasoline prices would “drop like a rock” once it does.

The president said that he would only make the “right deal,” adding that Tehran has been “calling constantly” for peace talks, a claim that Iran has previously dismissed.

Stalled Hormuz talks

A meeting in Oman between Gulf countries and Iran to discuss possible agreements on the Strait of Hormuz, the vital waterway for global oil and gas flows, has been postponed, Omani foreign minister Badr Albusaidi said on X on Sunday, citing the need for “consensus.”

Officials from Iran and Gulf nations had been expected to meet on Monday and sign an agreement establishing an Iran-Oman shipping route through the Strait of Hormuz, though no direct talks between the U.S. and Iran were ongoing.

The Strait of Hormuz has been subjected to an Iranian and later U.S. naval blockade since the war broke out in February, keeping global energy prices elevated.

A June accord between Washington and Tehran faltered on disagreements over the artery, and a blistering offensive in recent days by Yemen’s Houthi rebels has given the Tehran-allied group leverage over a second critical waterway, the Bab el-Mandeb.

Ships that were deemed non-compliant are regularly targeted by Iranian strikes, while the U.S. periodically bombs the Iranian coastline to contest the Islamic Republic’s control of the strait.

Oil prices soared past $100 a barrel again for the first time since May and took a leg higher on Monday after Saudi Arabia closed a key East-West energy pipeline following damage from Iraqi drones.

U.S. West Texas Intermediate futures were up 2.3% to $102.39 per barrel. Brent crude, the international benchmark, traded 2.4% higher to $107.11 a barrel.

Continue Reading

Trending

Copyright © Verum World Media