Covid shot
Moderna seeks FDA authorization for 4th dose of COVID shot
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.
2 years ago
Pfizer tests extra COVID shot for kids under 5 in setback
Pfizer said Friday it was changing plans and testing three doses of its COVID-19 vaccine in babies and preschoolers after the usual two shots didn’t appear strong enough for some of the children.
Pfizer announced the change after a preliminary analysis found 2- to 4-year-olds didn’t have as strong an immune response as expected to the very low-dose shots the company is testing in the youngest children.
It’s disappointing news for families anxious to vaccinate their tots. Pfizer had expected data on how well the vaccines were working in children under 5 by year’s end, and it’s not clear how long the change will delay a final answer.
Pfizer and its partner BioNTech said if the three-dose study is successful, they plan to apply for emergency authorization sometime in the first half of 2022.
Read: Pfizer says COVID booster offers protection against omicron
A kid-sized version of Pfizer’s vaccine already is available for 5- to 11-year-olds, one that’s a third of the dose given to everyone else 12 and older.
For children younger than 5, Pfizer is testing an even smaller dose, just 3 micrograms or a tenth of the adult dose.
Researchers analyzed a subset of youngsters in the study a month after their second dose to see if the tots developed levels of virus-fighting antibodies that were similar to teens and young adults who get the regular shots.
The very low-dose shots appeared to work in youngsters under age 2, who produced similar antibody levels. But the immune response in 2- to 4-year-olds was lower than the study required, Pfizer vaccine research chief Kathrin Jansen said Friday in a call with investors.
Read: Pfizer agrees to let other companies make its COVID-19 pill
Rather than trying a higher-dose shot for the preschoolers, Pfizer decided to expand the study to evaluate three of the very low-dose shots in all the study participants — from 6 months up to age 5. That third shot will come at least two months after the youngsters’ second dose.
No safety concerns have been spotted in the study, the companies said.
Jansen cited other data showing a booster shot for people 16 and older restores strong protection, a jump in immunity that scientists hope also will help fend off the new omicron variant.
The companies also are preparing to test a booster for 5- to 11-year-olds, who are just now getting their two-dose vaccinations. And they are testing different dose options for teen boosters.
Jansen said if the additional pediatric testing is successful, “we would have a consistent three-dose vaccine approach for all ages.”
2 years ago
To boost or not? Experts decry the third Covid shot debate
As the global debate over Covid booster shots gathers steam in wealthier countries, public health experts in Bangladesh contend it is still "premature" to roll out the third dose in this country.
They say that available vaccines would be better used to inoculate the unvaccinated -- not to mention that a large swath of the population in Bangladesh is yet to get the first shot.
Though some wealthier countries have already started administering the booster shots, the experts say there is no credible scientific evidence, except some sponsored studies, so far to support the need for the same.
Instead they urge the government to strengthen the ongoing vaccination drive and increase its coverage to ensure that at least 80 percent of the eligible population are inoculated with the first shot at the earliest.
Read: Resource for journalists around the world on COVID-19 vaccines
Some say the world may get very effective oral medicines to defeat the deadly virus in a couple of years.
2 years ago
FDA panel endorses lower-dose Moderna COVID shot for booster
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.
3 years ago
112 Manikganj students vaccinated under trial run
Some 112 students of four government schools in Manikganj were vaccinated on Thursday with Pfizer jabs as part of a test run of the government for vaccinating school students against Covid-19.
All the vaccinated students were of the 12-17 age group.
Sixty of the students were from Manikganj Government Boys High School, 32 from SK Government Girls High School, 10 from Zahid Maleque High School and another 10 from Bangabandhu High School.
Read: Trial run for school vaccination to begin Thursday with 100 Manikganj students
Although 120 students were supposed to be vaccinated on the day the health authorities decided not to vaccinate eight of them as they were suffering from various illnesses.
Inaugurating the trial run at 12 pm at Manikganj Colonel Malek Medical College, Health Minister Zahid Maleque said, “This vaccine (Pfizer) is safe and has been given to school kids in Europe and America as well.”
“We want our children to be safe, too. Soon, school children across the country will be brought under the vaccination drive,” he said.
Mobashbir Rahman Rafid, a 10th grader of Manikganj Government Boys High School, is the first child to receive Covid shot in Bangladesh.
“I was a little bit scared at first. But I felt no discomfort after receiving the vaccine. I’m over the moon to be the first child to be vaccinated,” he said.
Meanwhile, Taslima Akhter, another 10th grader of Zahid Maleque High School, was the first schoolgirl to be vaccinated in the country.
“Since school reopened, I have been suffering from a sense of fear to join classes because of Covid. Now I can attend classes without fear,” she said.
Read: Vaccination campaign for school students to begin within a week: DGHS chief
Principal of Colonel Malek Medical College and Hospital Dr Md Zakir Hossain said they are yet to receive any complaint from the vaccinated children.
On January 27, Prime Minister Hasina launched the Covid-19 vaccination programme at Kurmitola General Hospital through a videoconference.
The government rolled out a countrywide mass Covid-19 vaccination drive on February 7 vaccinating people aged 55 and above in the first phase.
On July 29, the government lowered the minimum age limit for taking Covid-19 jabs to 25 from 30 years in a bid to give a boost to the lagging vaccination rates in the country.
3 years ago
Chinese workers get a Covid shot in the arm
Chinese engineers and technicians working in mega projects in Bangladesh got their first dose of the Covid-19 vaccine on Saturday.
Moreover, about 1,000 students from Bangladesh's four leading medical colleges -- Dhaka Medical College and Hospital, Shaheed Suhrawardy Medical College, Sir Salimullah Medical College and Mugda Medical College -- have taken their first shot of the Covid vaccine produced by China's Sinopharm, said the Embassy.
Also read: Study: Sinopharm COVID-19 vaccines appear safe, effective
The Chinese government has gifted five lakh doses of the vaccine to Bangladesh.
UNB Dhaka University correspondent reports: The vaccination of Chinese citizens will continue until Sunday at Dhaka Medical College and Hospital (DMCH) underground vaccination booths of the emergency section.
A total of 456 Chinese citizens will be vaccinated, DMCH Director Brig. Gen. Md. Nazmul Haque told UNB.
Also read: Process to procure vaccine from China at final stage: FM"We got a letter from the Health Ministry. We will vaccinate a total of 456 Chinese citizens by tomorrow," he said.Bangladesh's drug regulator on April 29 authorized the emergency use of Sinopharm Covid-19 vaccine in the country.
3 years ago