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. The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases once again are rising. The 18 million tots under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination. The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to begin offering two kid-sized shots by summer. Pfizer has had a bumpier time figuring out its approach. It aims to give tots an even lower dose — just one-tenth of the amount adults receive — but discovered during its trial that two shots didn’t seem quite strong enough for preschoolers. So researchers gave a third shot to more than 1,600 youngsters — from age 6 months to 4 years — during the winter surge of the omicron variant. Also read: CDC urges Pfizer booster for children ages 5 to 11 In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, revving up tots’ levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems. Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available. The companies already had submitted data on the first two doses to the FDA, and BioNTech’s CEO, Dr. Ugur Sahin, said the final third-shot data would be submitted this week. “The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” he said in a statement. What’s next? 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. The agency has set tentative dates next month for its scientific advisers to publicly debate data from each company. Also read: WHO recommends Pfizer's Covid pill Paxlovid Moderna is seeking to be the first to vaccinate the littlest kids. It submitted data to the FDA saying tots develop high levels of virus-fighting antibodies after two shots that contain a quarter of the dose given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during the omicon surge, much like for adults who’ve only had two vaccine doses. Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults. The FDA is expected to review Moderna’s data on both the youngest age group, plus its study of teens and elementary-age children. Other countries already have expanded Moderna’s shot to kids as young as 6. While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. And the omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge. It’s not clear how much demand there will be to vaccinate the youngest kids. 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. Last week, U.S. health authorities said elementary-age children should get a booster shot just like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.

COVID-19 vaccinations are at a critical juncture as companies test whether new approaches like combination shots or nasal drops can keep up with a mutating coronavirus — even though it’s not clear if changes are needed. Already there’s public confusion about who should get a second booster now and who can wait. There’s also debate about whether pretty much everyone might need an extra dose in the fall. “I’m very concerned about booster fatigue” causing a loss of confidence in vaccines that still offer very strong protection against COVID-19’s worst outcomes, said Dr. Beth Bell of the University of Washington, an adviser to the U.S. Centers for Disease Control and Prevention. Also raed:Beijing on alert after COVID-19 cases discovered in school Despite success in preventing serious illness and death, there’s growing pressure to develop vaccines better at fending off milder infections, too — as well as options to counter scary variants. “We go through a fire drill it seems like every quarter, every three months or so” when another mutant causes frantic tests to determine if the shots are holding, Pfizer vaccine chief Kathrin Jansen told a recent meeting of the New York Academy of Sciences. Yet seeking improvements for the next round of vaccinations may seem like a luxury for U.S. families anxious to protect their littlest children — kids under 5 who are not yet eligible for a shot. Moderna’s Dr. Jacqueline Miller told The Associated Press that its application to give two low-dose shots to the youngest children would be submitted to the Food and Drug Administration “fairly soon.” Pfizer hasn’t yet reported data on a third dose of its extra-small shot for tots, after two didn’t prove strong enough. COMBINATION SHOTS MAY BE NEXT The original COVID-19 vaccines remain strongly protective against serious illness, hospitalization and death, especially after a booster dose, even against the most contagious variants. Updating the vaccine recipe to match the latest variants is risky, because the next mutant could be completely unrelated. So companies are taking a cue from the flu vaccine, which offers protection against three or four different strains in one shot every year. Moderna and Pfizer are testing 2-in-1 COVID-19 protection that they hope to offer this fall. Each “bivalent” shot would mix the original, proven vaccine with an omicron-targeted version. Moderna has a hint the approach could work. It tested a combo shot that targeted the original version of the virus and an earlier variant named beta — and found vaccine recipients developed modest levels of antibodies capable of fighting not just beta but also newer mutants like omicron. Moderna now is testing its omicron-targeted bivalent candidate. But there’s a looming deadline. FDA’s Dr. Doran Fink said if any updated shots are to be given in the fall, the agency would have to decide on a recipe change by early summer. DON’T EXPECT BOOSTERS EVERY FEW MONTHS For the average person, two doses of the Pfizer or Moderna vaccine plus one booster — a total of three shots — “gets you set up” and ready for what may become an annual booster, said Dr. David Kimberlin, a CDC adviser from the University of Alabama at Birmingham. After that first booster, CDC data suggests an additional dose offers most people an incremental, temporary benefit. Also read: WHO recommends Pfizer's Covid pill Paxlovid Why the emphasis on three shots? Vaccination triggers development of antibodies that can fend off coronavirus infection but naturally wane over time. The next line of defense: Memory cells that jump into action to make new virus-fighters if an infection sneaks in. Rockefeller University researchers found those memory cells become more potent and able to target more diverse versions of the virus after the third shot. Even if someone who’s vaccinated gets a mild infection, thanks to those memory cells “there’s still plenty of time to protect you against severe illness,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia. But some people — those with severely weakened immune systems — need more doses up-front for a better chance at protection. And Americans 50 and older are being offered a second booster, following similar decisions by Israel and other countries that offer the extra shot to give older people a little more protection. The CDC is developing advice to help those eligible decide whether to get an extra shot now or wait. Among those who might want a second booster sooner are the elderly, people with health problems that make them particularly vulnerable, or who are at high risk of exposure from work or travel. COULD NASAL VACCINES BLOCK INFECTION? It’s hard for a shot in the arm to form lots of virus-fighting antibodies inside the nose where the coronavirus latches on. But a nasal vaccine might offer a new strategy to prevent infections that disrupt people’s everyday lives even if they’re mild. “When I think about what would make me get a second booster, I actually would want to prevent infection,” said Dr. Grace Lee of Stanford University, who chairs CDC’s immunization advisory committee. “I think we need to do better.” Nasal vaccines are tricky to develop and it’s not clear how quickly any could become available. But several are in clinical trials globally. One in late-stage testing, manufactured by India’s Bharat Biotech, uses a chimpanzee cold virus to deliver a harmless copy of the coronavirus spike protein to the lining of the nose. “I certainly do not want to abandon the success we have had” with COVID-19 shots, said Dr. Michael Diamond of Washington University in St. Louis, who helped create the candidate that’s now licensed to Bharat. But “we’re going to have a difficult time stopping transmission with the current systemic vaccines,” Diamond added. “We have all learned that.”

Hospitalizations of U.S. children under 5 with COVID-19 soared in recent weeks to their highest level since the pandemic began, according to government data released Friday on the only age group not yet eligible for the vaccine. The worrisome trend in children too young to be vaccinated underscores the need for older kids and adults to get their shots to help protect those around them, said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. Since mid-December, with the highly contagious omicron variant spreading furiously around the country, the hospitalization rate in these youngest kids has surged to more than 4 in 100,000 children, up from 2.5 per 100,000. The rate among children ages 5 to 17 is about 1 per 100,000, according to the CDC data, which is drawn from over 250 hospitals in 14 states. Overall, “pediatric hospitalizations are at their highest rate compared to any prior point in the pandemic,” Walensky said. Also read: Omicron may sideline two leading drugs against COVID-19 She noted that just over 50% of children ages 12 to 18, and only 16% of those 5 to 11, are fully vaccinated. The overall hospitalization rate among children and teens is still lower than that of any other age group. And they account for less than 5% of average new daily hospital admissions, according to the CDC. As of Tuesday, the average number of under-18 patients admitted to the hospital per day with COVID-19 was 766, double the figure reported just two weeks ago. The trend among the very youngest kids is being driven by high hospitalization rates in five states: Georgia, Connecticut, Tennessee, California and Oregon, with the steepest increases in Georgia, the CDC said. At a briefing, Walensky said the numbers include children hospitalized because of COVID-19 and those admitted for other reasons but found to be infected. The CDC also said the surge could be partially attributable to how COVID-19 hospitalizations in this age group are defined: a positive virus test within 14 days of hospitalization for any reason. The severity of illness among children during the omicron wave seems lower than it was with the delta variant, said Seattle Children’s Hospital critical care chief Dr. John McGuire. Also read: UK health boss: COVID-19 rules could tighten by Christmas “Most of the COVID+ kids in the hospital are actually not here for COVID-19 disease,” McGuire said in an email. “They are here for other issues but happen to have tested positive.” The nation’s top infectious-disease expert, Dr. Anthony Fauci, said earlier this week that omicron appears to cause less-severe disease across the board, but that the sheer number of infections because of its extreme contagiousness will mean that many more children will get infected, and a certain share of them will wind up in the hospital. Fauci also said many children hospitalized with COVID-19 have other health conditions that make them more susceptible to complications from the virus. That includes obesity, diabetes and lung disease. Fauci and Walensky have emphasized that one of the best ways to protect the youngest children is to vaccinate everyone else. The surge in hospitalizations only heightens some parents’ worries. Emily Hojara and Eli Zilke of Sawyer, Michigan, are being extra protective of their daughter Flora, who turns 2 in May. They limit her contact with other children, and no visitors are allowed in the house unless masked, not even grandparents. “It’s been a struggle, and now with this new variant, I feel it’s knocked us back,” Hojara said. “It’s scary that she can’t be vaccinated,” she said of her daughter. Dr. Jennifer Kusma, a pediatrician with Chicago’s Lurie Children’s Hospital, said she has seen increasing numbers of kids hospitalized with omicron, and while most aren’t severely ill, she understands parents’ worries. “I really wish we already had that vaccine for these young kids,” Kusma said. But she added that what may seem like a long wait should reassure parents that vaccine testing is not being rushed. Many had hoped the new year might bring a vaccine for young children, but Pfizer announced last month that two doses didn’t offer as much protection as hoped for in youngsters 2 to 4. Pfizer’s study has been updated to give everyone under 5 a third dose, and data is expected in early spring. Also on Friday, the CDC issued a report showing Pfizer shots seem to protect older children who develop a serious but rare COVID-19-linked condition that involves inflammation of multiple organs. Among 102 kids ages 12 to 18 who were hospitalized with the condition, none who had received two Pfizer shots at least 28 days earlier needed ventilators or other advanced life support. By contrast, 40% of unvaccinated children required such treatment. The condition, multisystem inflammatory syndrome, causes symptoms that may include persistent fever, abdominal pain and rashes. Most children recover, but 55 deaths have been reported. A separate CDC report found that children who had COVID-19 were more than twice as likely to be diagnosed with diabetes as youngsters who had not had the virus. Scientists are investigating why but say the virus seems to attack insulin-producing cells in the pancreas.

The pastor opened the wrought-iron doors of St. Petri Church in the German city of Chemnitz and sighed with relief when he saw the long line of people waiting in the cold for shots against the coronavirus. Together with the parish council, the Rev. Christoph Herbst had invited in a relief organization and volunteer doctors to conduct a Sunday vaccination clinic at the Lutheran church. The act of community outreach, the pastor knew, might not go over well in a part of Germany prone to vaccine resistance, including sometimes violent protests. “I was very insecure about how people would react to our offer,” Herbst said as he welcomed the waiting crowd into his neo-Gothic house of prayer. “In our region, there are very different and very polarized views about the coronavirus measures in general, about how to fight the pandemic, and especially about the vaccinations.” Saxony state, where Chemnitz and the city of Dresden are located, has the lowest vaccination rate among Germany’s 16 federal states, and one of the highest numbers of COVID-19 cases. Only 60.1% of residents were fully vaccinated by Christmas, compared to the nationwide average of 70.8%. At some points in the pandemic, local hospitals had to transfer patients out of state because all the intensive care beds were full. Lutheran pastors across Saxony have used their sermons to promote vaccines as the most efficient way to prevent severe illness and to end the pandemic. Like Herbst, many opened their churches for clinics this month, hoping that offering jabs in a familiar environment and without advance registration might persuade some holdouts. “We believe that we have a responsibility that goes beyond ourselves, and that we should do something for society with the resources we have,” Herbst explained. “We’re not doctors and we’re not professionals. But we have the space and we have volunteers who can organize something like this.” Read: US officials recommend shorter COVID isolation, quarantine Chemnitz, a city of about 247,000 residents, was known as Karl-Marx-Stadt when it and the rest of Saxony were part of the former communist East Germany. Many of the local vaccine refusers cite concerns of possible side effects, but also feeling overwhelmed by what they see as too much pressure from authorities or general opposition to any measures endorsed by the government, according to Herbst. Among those who patiently sat in a pew waiting to roll up their sleeves at Herbst’s church were Hannelore and Bernd Hilbert, a retired couple from the nearby village of Amtsberg. They came to get booster shots because some of their five grandchildren are too young to be vaccinated, and the Hilberts hoped to see them for Christmas. “Last year’s Christmas was really sad. We were all alone,” Hannelore Hilbert, 70. said. “We’re grateful for the church to offer these shots,” added her 72-year-old husband, who said they had waited unsuccessfully for shots at a hospital a few days earlier. The vast majority of the church’s vaccine recipients on a recent Sunday turned out to have more in common with the booster-seeking couple than the skeptical or frightened community members Saxony’s pastors are trying to reach. Of the 251 vaccines administered during St. Petri’s daylong clinic, 18 went to individuals receiving their first dose. None of them wanted to speak with The Associated Press about why they’d changed their minds and decided to get shots almost one year into Germany’s mass immunization campaign. A loud minority in Germany has opposed any kind of anti-virus measures since the start of the pandemic. The resistance grew angrier and more aggressive in recent weeks after the national parliament this month passed a vaccine mandate for some professions and most of the country’s regions resumed some form of restrictions in response to the latest wave of infections. Read: Immigrants welcome Afghan refugees, inspired by own journeys With mass demonstrations banned in several parts of the country due to the pandemic, vaccine opponents have gathered for protest “walks” - unauthorized marches organized quickly via social media. Around 30 protesters showed up with torches outside the home of Saxony state Health Minister Petra Koepping one night, shouting slurs until police arrived. The protests swelled in recent days, sometimes drawing thousands of people. Police detained several participants for attacking officers and journalists. Some Lutheran pastors received criticism and personal threats for their efforts to encourage vaccination. Herbst said he thinks the majority of Saxons back the country’s immunization campaign and that far-right groups intent on undermining democracy have coopted anti-vaccine sentiment, fueling an already present sense among residents of Germany’s east of feeling left behind 30 years after the country’s reunification. When parishioners confront him with their opposition to vaccines, the pastor says he tries to listen instead of judge. “And I listen to things that are sometimes difficult to hear,” he said. “I also listen to things that I think belong in the realm of conspiracy theories. I don’t confirm those. But it’s important that there’s a space where we listen to each other without immediately lapsing into condemnation.” However, the pastor wonders if at this point all the arguments for and against vaccination have been exchanged and the decision of whether or not to get immunized no longer should be left as a matter of personal choice. “There are people who say what is needed now is a democratically legitimized decision by parliament on a general vaccine mandate,” Herbst said. “That would be a decision that does not work on moral pressure, but rather on the basis of a set of rules that applies to everyone.”

After a vaccination drive at Korail slum in Dhaka, health authorities have started giving Covid jabs to the slum dwellers of Chattogram city on Sunday. Some 2,000 residents of Jhautala slum in Khulshi area will get the jabs under the programme which started around 2 pm, according to the Civil Surgeon’s office. The dwellers of all other slums in the city will be brought under the vaccination programme in phases, it said. Read:Covid jabs for city’s slum dwellers start on Tuesday: Health Minister Apart from the slum dwellers, the third gender  people will also be brought under the vaccination programme, and it will start on Monday. The dwellers of Jhautala slum will be allowed to get vaccinated without registration and the campaign will continue till Thursday. According to the Civil Surgeon office, the vaccination drive will continue till 5 pm, and a three-member medical team is there to provide vaccine doses to the slum dwellers. Dr Ilias Hossain, the District Civil Surgeon, said the Jhautala slum residents will be able to get their Covid shots on Sunday, Tuesday and Thursday. Read:7.5 crore people to be fully vaccinated by Jan: Health Minister Already some 300 doses of Astrazeneca vaccine have been allocated for the transgender people  and the number of doses will be increased depending the number of vaccine seekers. The vaccination drive for the residents of Korail slum in Dhaka started on November 16. According to the slum census conducted by the Bangladesh Statistics Bureau (BSS), in 2014, some 1.28 lakh people are living in 2,216 slums in Chattogram city corporation area.

Scientists look for safety issues during the testing phase and continue their monitoring as shots roll out around the world. So far, the only serious warning to emerge is a rare risk of severe allergic reactions.