Pfizer
Pfizer says COVID-19 vaccine more than 90% effective in kids
Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group.
The shots could begin in early November, with the first children in line fully protected by Christmas, if regulators give the go-ahead. That would represent a major expansion of the nation’s vaccine drive, encompassing roughly 28 million elementary school-age youngsters.
Details of Pfizer’s study were posted online. The Food and Drug Administration was expected to post its own review of the company’s safety and effectiveness data later in the day.
Advisers to the FDA will publicly debate the evidence next week. If the agency itself authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them.
Full-strength Pfizer shots already are authorized for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections and record hospitalizations among them from the extra-contagious delta variant and to help keep kids in school.
The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.
Read: Pfizer's request to OK shots for kids a relief for parents
More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.
The Pfizer study tracked 2,268 children in the 5-to-11 group who got two shots three weeks apart of either a placebo or the low-dose vaccine. Each dose was one-third the amount given to teens and adults.
Researchers calculated the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.
Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.
In addition, young children given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who got regular-strength vaccinations.
In another piece of encouraging news, the CDC reported earlier this week that even as the delta variant surged over the summer, Pfizer vaccinations were 93% effective at preventing hospitalizations among 12- to 18-year-olds.
Read: World could return to normal within a year: Pfizer CEO
Pfizer’s study of younger children found the low-dose shots proved safe, with similar or fewer temporary side effects such as sore arms, fever or achiness that teens experience.
The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men.
While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.
Moderna also is studying its COVID-19 shots in elementary school-age youngsters. Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.
Pfizer's request to OK shots for kids a relief for parents
Parents tired of worrying about classroom outbreaks and sick of telling their elementary school-age children no to sleepovers and family gatherings felt a wave of relief Thursday when Pfizer asked the U.S. government to authorize its COVID-19 vaccine for youngsters ages 5 to 11.
If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks.
That could bring many families a step closer to being done with remote learning, virus scares and repeated school shutdowns and quarantines.
Also read: J&J seeks US clearance for COVID-19 vaccine booster doses
“My son asked about playing sports. ‘After you’re vaccinated.’ He asked about seeing his cousins again. ‘After you’re vaccinated.’ A lot of our plans are on hold,” said Sarah Staffiere of Waterville, Maine, whose 7-year-old has a rare immune disease that has forced the family to be extra cautious throughout the pandemic.
“When he’s vaccinated, it would give our family our lives back,” she said.
Expanding vaccine availability to roughly 28 million more U.S. children is seen as another milestone in the fight against the virus and comes amid an alarming rise in serious infections in youngsters because of the extra-contagious delta variant.
It would also push the U.S. vaccination drive further ahead of much of the rest of the world at a time when many poor countries are desperately short of vaccine.
The Food and Drug Administration must decide whether the shots are safe and effective in younger children.
Also read: Am I fully vaccinated without a COVID-19 vaccine booster?
Many parents and pediatricians are clamoring for protection for youngsters under 12, the current age cutoff for COVID-19 vaccinations in the U.S.
Nine-year-old Audrey Moulder, who lives in the Philadelphia suburb of Drexel Hill, is looking forward to visiting her grandmother without worrying she will give the older woman COVID-19.
“She’s excited because she thinks it’s a responsibility,” said her father, Justin Moulder. “She wants to keep her friends safe and her family safe.”
Dr. Amanda Powell, an internist and pediatrician who runs a clinic in Portland, Maine, is eager to set up worry-free play dates and plan a family trip again once her 9-year-old son is vaccinated.
“We want to be able to resume some normal activities,” she said.
But there are also plenty of parents who are wary about getting the shot themselves and are in no hurry to have their children vaccinated.
Heather Miller, a mother of four from Dexter, Maine, said she wants to wait for follow-up studies on the vaccine. “I’m not 100% against getting it eventually, but I kind of fall into the ‘not right now, wait and see’ category,” she said.
Cindy Schilling, an elementary school principal in West Virginia, which ranks dead last in the percentage of fully vaccinated residents, said it has been a rough start to the year because so many children are testing positive or quarantining at different times, making it hard for teachers and students to stay on track.
Still, she said she often hears parents say they are more concerned about the effects of the vaccine than COVID-19.
“Some parents are all for it and getting it for peace of mind,” she said, “but the majority of parents I’ve talked to will not be getting it.”
While kids are at lower risk of severe illness or death than older people, COVID-19 does sometimes kill children — at least 520 so far in the U.S., according to the American Academy of Pediatrics.
Pfizer and its German partner BioNTech said their research shows younger children should get one-third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as those that teens and young adults get from regular-strength shots.
On Oct. 26, an independent expert panel that advises the FDA will publicly debate the evidence. If the FDA authorizes emergency use of the kid-size doses, the Centers for Disease Control and Prevention will make a final decision, after hearing from its outside advisers.
To avoid mix-ups, Pfizer is planning to ship the lower-dose vials specially marked for use in children.
It studied the lower dose in 2,268 volunteers ages 5 to 11 and said there were no serious side effects. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine, mostly in young men.
Moderna has requested FDA permission to use its vaccine in 12- to 17-year-olds and also is studying its shots in elementary school children. Both Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.
World could return to normal within a year: Pfizer CEO
There will be a return to normal life within a year, according to Pfizer CEO and Chairman Albert Bourla.
To make that happen, it is likely annual Covid vaccination shots will be needed, he added.
"Within a year I think we will be able to come back to normal life," Bourla said in an interview with ABC.
READ: Dhaka to receive another 25 lakh Pfizer vaccine doses Monday
"I do not think that this means that the variants will not continue coming, and I do not think that this means that we should be able to live our lives without having vaccinations. But that, again, remains to be seen," he added.
Earlier, when asked for his estimate of a return to normal life, Moderna CEO Stéphane Bancel told the Swiss newspaper Neue Zuercher Zeitung: "As of today, in a year, I assume."
READ: Bangladesh to get 71 lakh Pfizer, 18 lakh Moderna jabs: Shahriar
Bangladesh to get 71 lakh Pfizer, 18 lakh Moderna jabs: Shahriar
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 aged 12-17 to be vaccinated after WHO’s approval: Minister
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
US regulators give full approval to Pfizer COVID-19 vaccine
The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, a milestone that could boost public confidence in the shots and spur more companies, universities and local governments to make vaccinations mandatory.
The Pentagon immediately announced it will press ahead with plans to require members of the military to get the vaccine as the U.S., and the world, battle the extra-contagious delta variant.
The formula made by Pfizer and its German partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. More than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide — under special emergency provisions since December.
Pfizer said the U.S. is the first country to grant the company’s vaccine full approval. The shot will be marketed in the U.S. under the brand name Comirnaty.
Moderna has also applied to the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later this year.
Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, shots are on the rise again, with a million a day given Thursday, Friday and Saturday.
Full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.
Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidance on vaccinations will be worked out and a timeline will be provided in the coming days.
The FDA’s action may also lead to more vaccine mandates covering students, employees and customers.
READ: Pfizer to discuss vaccine booster with US officials Monday
“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”
This month, New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.
Anxious Americans increasingly are on board: Close to 6 in 10 favor requiring people to be fully vaccinated to fly or attend crowded public events, according to a recent poll by The Associated Press-NORC Center for Public Affairs Research.
The delta variant has sent cases, deaths and hospitalizations soaring in recent weeks in the U.S., erasing months of progress. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January.
“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected,” said Dr. Tomas J. Aragon, director of California’s public health department. “If you are not vaccinated, let this be the milestone that gets you there.”
READ: Bangladesh to receive 60 lakh more Pfizer vaccine doses in Aug: Minister
The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.
That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding whether to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot is still being dispensed to 12- to 15-year-olds on an emergency basis.
Normally, doctors can prescribe FDA-approved products for other reasons than their original use. But Woodcock strongly warned that the Pfizer vaccine should not be used “off-label” for children under 12.
Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using different doses from what is available for those 12 and older. Results are expected in the fall.
Also, Woodcock said health providers are offering COVID-19 vaccines under agreements with the government that should preclude using Monday’s approval as a pretext for offering booster shots to the general population.
Currently, the FDA has authorized third doses of either Pfizer’s or Moderna’s vaccine only for certain people with severely weakened immune systems, such as organ transplant recipients. For everyone else, the Biden administration is planning for boosters starting in the fall. But the FDA is evaluating that question separately.
In reaching Monday’s decision, the FDA said safety tracking of millions of doses found serious side effects remain extremely rare, such as chest pain and heart inflammation a few days after the second dose, mostly in young men.
As for effectiveness, six months into Pfizer’s original study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.
Those findings came before the delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.
US OK’d extra Covid vaccine dose for those with weak immune systems
U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge.
The late-night announcement Thursday by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.
It’s harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don’t always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.
Also read: The link between the COVID-19 vaccine and pregnancy
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.
The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.
The announcement comes as the extra-contagious delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.
Importantly, the FDA’s decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It’s not an opening for booster doses for the general population.
Also read: Moderna says vaccine 93% effective but seeks 3rd-shot in fall
Instead, health authorities consider the extra dose part of the initial prescription for the immune-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot. Israel and Germany also recently began recommending a third dose of two-dose vaccines.
Separately, U.S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.
The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.
Transplant recipients and others with suppressed immune systems know they’re at more risk than the average American and some have been seeking out extra doses on their own, even if it means lying about their vaccination status. The change means now the high-risk groups can more easily get another shot — but experts caution it’s not yet clear exactly who should.
“This is all going to be very personalized,” cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third dose “increases their immune response. Yet for some people it does not seem to. We don’t quite know who’s who yet.”
One recent study of more than 650 transplant recipients found just over half harbored virus-fighting antibodies after two doses of the Pfizer or Moderna vaccines — although generally less than in otherwise healthy vaccinated people. Another study of people with rheumatoid arthritis and similar autoimmune diseases found only those who use particular medications have very poor vaccine responses.
There’s little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection. Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they got a third dose than those given a dummy shot for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose while others still lack enough protection.
What is a COVID-19 vaccine “breakthrough” case?
It’s when a fully vaccinated person gets infected with the coronavirus. A small number of such cases are expected and health officials say they’re not a cause for alarm.
COVID-19 vaccines work by teaching the body to recognize the virus. So if you’re exposed to it after vaccination, your immune system should be ready to spring into action and fight it.
In studies, the two-dose COVID-19 vaccines by Pfizer and Moderna were around 95% effective at preventing illness, while the one-shot Johnson & Johnson shot was 72% effective, though direct comparisons are difficult. So while the vaccines are very good at protecting us from the virus, it’s still possible to get infected with mild or no symptoms, or even to get sick.
Also read: Challenges remain despite Europe meeting 70 pct vaccine delivery goal
If you do end up getting sick despite vaccination, experts say the shots are very good at reducing the severity of the illness — the main reason to get vaccinated.
Most people with breakthrough infections experience mild illness, said Dr. William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health.
In the U.S., people who weren’t vaccinated make up nearly all hospitalizations and deaths from COVID-19.
It’s difficult to determine why any particular breakthrough case happens. How much of the virus you’re exposed to could be a factor, Moss said. Our individual immune systems will also affect how well we respond to the shots. Some people, for example, have health conditions or take medications that could make their immune systems less responsive to the vaccines.
People might also have been exposed to the virus before the shots took full effect. Though less likely, they may have received a dose that was improperly stored or administered, Moss said.
Also read: Immunized but banned: EU says not all COVID vaccines equal
The Centers for Disease Control and Prevention notes variants could be factors in some breakthrough cases, though evidence so far indicates the vaccines used in the U.S. are protective against them.
Health officials are also watching for signs that breakthrough cases are rising, which could signal that protection from the vaccines is fading and boosters are needed.
All adults to be gradually vaccinated: Health Minister
Expanding the vaccine eligibility target, Health Minister Zahid Maleque on Thursday said everyone above 18 years will gradually be vaccinated in Bangladesh.
“Arrangements are being made to gradually bring all citizens above 18 years under the Covid-19 vaccination programme in order to revive the country's education system,” he said.
Zahid Maleque came up with the remarks while speaking as the chief guest at a progamme on Covid-19 ICU Bed Expansion and inauguration of Outpatient Department of Dhaka Medical College and Hospital (DMCH).
Also read: 35-years-olds to be made eligible for Covid jabs: DGHS DG
“At present, the government has 45 lakh doses of vaccines in stock. We’ll receive 29 lakh doses of AstraZeneca vaccine very soon. Besides, Pfizer vaccine doses will reach the country within the next month,” he added.
Pfizer to discuss vaccine booster with US officials Monday
Pfizer says it plans to meet with top U.S. health officials Monday to discuss the drugmaker’s request for federal authorization of a third dose of its COVID-19 vaccine as President Joe Biden’s chief medical adviser acknowledged that “it is entirely conceivable, maybe likely” that booster shots will be needed.
The company said it was scheduled to have the meeting with the Food and Drug Administration and other officials Monday, days after Pfizer asserted that booster shots would be needed within 12 months.
Pfizer’s Dr. Mikael Dolsten told The Associated Press last week that early data from the company’s booster study suggests people’s antibody levels jump five- to 10-fold after a third dose, compared to their second dose months earlier — evidence it believes supports the need for a booster.
Read:Pfizer to seek OK for 3rd vaccine dose; shots still protect
On Sunday, Dr. Anthony Fauci didn’t rule out the possibility but said it was too soon for the government to recommend another shot. He said the Centers for Disease Control and Prevention and the FDA did the right thing last week by pushing back against Pfizer’s assertion with their statement that they did not view booster shots as necessary “at this time.”
Fauci said clinical studies and laboratory data have yet to fully bear out the need for a booster to the current two-shot Pfizer and Moderna vaccines or the one-shot Johnson & Johnson regimen.
“Right now, given the data and the information we have, we do not need to give people a third shot,” he said. “That doesn’t mean we stop there. ... There are studies being done now ongoing as we speak about looking at the feasibility about if and when we should be boosting people.”
He said it was quite possible in the coming months “as data evolves” that the government may urge a booster based on such factors as age and underlying medical conditions. “Certainly it is entirely conceivable, maybe likely at some time, we will need a boost,″ Fauci said.
Read:AstraZeneca, Pfizer vaccines effective against Delta Covid-19 variants: Study
Monday’s planned meeting between Pfizer and U.S. health officials was first reported by The Washington Post.
Currently only about 48% of the U.S. population is fully vaccinated. Some parts of the country have far lower immunization rates, and in those places the delta variant is surging. Last week, Dr. Rochelle Walensky, the CDC director, said that’s leading to “two truths” — highly immunized swaths of America are getting back to normal while hospitalizations are rising in other places.
Fauci said it was inexplicable that some Americans are so resistant to getting a vaccine when scientific data show how effective it is in staving off COVID-19 infections and hospitalizations, and he was dismayed by efforts to block making vaccinations more accessible, such as Biden’s suggestion of door-to-door outreach.
Gov. Asa Hutchinson, R-Ark., agreed Sunday that there is a vaccine resistance in Southern and rural states like his because “you have that more conservative approach, skepticism about government.”
Read:AP source: US to buy 500M Pfizer vaccines to share globally
Describing his efforts to boost vaccinations in his state, which is seeing rising infections, Hutchinson said “no one wants an agent knocking on a door,” but “we do want those that do not have access otherwise to make sure they know about it.”
The grassroots component of the federal vaccination campaign has been in operation since April, when supplies of shots began outpacing demand. It was outlined and funded by Congress in the $1.9 trillion COVID-19 relief bill passed in March and overwhelmingly is carried out by local officials and private sector workers and volunteers.
Rep. Adam Kinzinger, R-Ill., blasted opposition to vaccination efforts from some GOP lawmakers as “absolute insanity.” He said House Republican leader Kevin McCarthy of California and others in the party need to speak out against “these absolute clown politicians playing on your vaccine fears for their own selfish gain.”
Fauci appeared on CNN’s “State of the Union,” ABC’s “This Week” and CBS’ “Face the Nation”; Hutchinson spoke on ABC, and Kinzinger was on CNN.