coronavirus vaccine
Booster doses to be rolled out on trial basis from Sunday: Health Minister
Covid-19 booster doses will be administered on trial basis from Sunday, said Health Minister Zahid Maleque.
However, the minister did not mention the time and vaccination center where the booster doses will be administered.
The minister said this at a Pitha-Puli festival in Manikganj on Friday.
Maleque said the government decided to administer booster doses to senior citizens aged above 60 and frontliners, including doctors, nurses, government officials and journalists, who got the two doses of vaccine six months ago.
He said that all the activities to administer booster doses are underway. “The Prime Minister also has given approval to start a booster dose.”
In this regard, steps to update the ‘Surokkha’ app are in progress. Besides, lists of those who are eligible for booster dose are being prepared, said the minister.
Read: Covid booster doses to start within 7-10 days: Minister
Zahid Maleque said seven crore people received the first dose and 4.5 crore people have been fully vaccinated so far in Bangladesh.
There is no shortage of covid vaccines in the country. Currently, seven lakh doses of Pfizer vaccines are in stock. In all, 4.45 crore doses of vaccine are in stock.
Two crore more doses of vaccine will arrive next month, the minister added.
On Wednesday, Zahid Maleque said at a programme while receiving 80 lakh doses of AstraZeneca vaccine donated by Japan and UK through the global COVAX facility that the drive to administer Covid-19 booster doses will be in the next seven to ten days.
On Monday, the Cabinet directed the authorities concerned, particularly the Health Minister and the National Technical Advisory Committee on Covid-19, to work on a precise guideline over the campaign of booster dose of Covid-19 vaccine in Bangladesh.
PM also instructed earlier the technical committee to work on a precise guideline over when the booster dose campaign needs to be started.
On Sunday, the National Technical Advisory Committee (NTAC) on Covid-19 recommended booster shots to the citizens above 60 and frontliners.
Read: National Committee recommends booster dose for above 60 citizens, frontliners
The senior citizens and frontliners who got the two doses of vaccine six months ago will get the booster dose, the NTAC recommended at a meeting.
It also suggested all to take steps to limit public gatherings, meetings and rallies to contain the spread of Omicron.
On December 9, the World Health Organization (WHO) said Omicron is now present in 57 countries and asked all countries to stay alert about the new variant.
A WHO panel named the Coronavirus variant ‘Omicron’ and classified it as a highly transmissible virus of concern, the same category that includes the predominant delta variant, which is still a scourge driving higher cases of sickness and death in Europe and parts of the USA.
Amid the growing concern over the new ‘Omicron’ variant of coronavirus, the Directorate General of Health Services (DGHS) suggested the implementation of 15 instructions to prevent the spread of the new variant and urged all concerned to take measures to enforce the instructions.
2 years ago
77.8% efficacy, robust antibody response: 5 points from Lancet's new study on Covaxin
The Lancet peer-review has now corroborated Hyderabad-based Bharat Biotech's efficacy analysis regarding Covaxin, its coronavirus disease (Covid-19) vaccine, and confirmed that the shot demonstrates 77.8 per cent efficacy against patients symptomatic with the infectious disease, reports the Hindustan Times.
1 . In its new study, The Lancet noted that the Covid-19 vaccine made by Bharat Biotech is ‘highly efficacious’ and presents no safety concern, also inducing a “robust antibody response” two weeks after two doses of the shot are administered.
2. The Lancet journal, although it corroborated Bharat Biotech's efficacy analysis for Covaxin, also noted that more research is needed to understand more about Covaxin's long-term safety and effectiveness, as well as protection against hospitalisation.
Read:Anti-Covid pill likely to get approved in India soon, DCGI reviewing data
3. Further research is also needed to effectively study Covaxin's effect on deterring Covid-19 deaths, and also its ability to fend off the Delta variant and other variants of concern of the coronavirus.
4. Only 684 suspected Covid-19 cases were identified at least 14 days after the second dose, among the total 24,419 participants who received both doses of the vaccine.
5. Of the confirmed cases, nine did not meet the case definition, being either seropositive for SARS-CoV-2 at baseline or only having one symptom, and thus 130 cases were included in the efficacy analysis. 24 (0.3 per cent) cases occurred among 8471 participants in the vaccine group and 106 (1.2 per cent) among 8502 participants in the placebo group, resulting in an estimated vaccine efficacy of 77.8 per cent.
Notably, Covaxin was recently granted the much-coveted emergency use authorisation (EUA) by the World Health Organisation (WHO) and the shot has already been cleared for use in as many as 17 nations. With the recent green signal from the global health body, Covaxin has now joined a shortlist of anti-Covid vaccines approved by WHO – which include the shots manufactured by AstraZeneca/Oxford, Johnson&Johnson, Moderna, Pfizer/BioNTech, Sinopharm, and Sinovac.
While approving Covaxin, WHO noted that this vaccine is “extremely suitable for low- and middle-income countries due to easy storage requirements”.
Read: Pfizer asks FDA to OK COVID-19 booster shots for all adults
Bharat Biotech had informed back in July that the safety and efficacy analysis data from the Phase-III clinical trials of Covaxin had shown an efficacy rate of 77.8 per cent against mild, moderate, and severe instances of Covid-19. Against severe symptomatic cases of Covid-19, on the other hand, Covaxin was found to be 93.4 per cent effective, the Hyderabad-based pharmaceutical firm had said.
The Phase III trials for Covaxin were conducted on 25,798 subjects – aged between 18 to 98 years – across 25 sites in India.
2 years ago
US gives final clearance to COVID-19 shots for kids 5 to 11
U.S. health officials on Tuesday gave the final signoff to Pfizer’s kid-size COVID-19 shot, a milestone that opens a major expansion of the nation’s vaccination campaign to children as young as 5.
The Food and Drug Administration already authorized the shots for children ages 5 to 11 — doses just a third of the amount given to teens and adults. But the Centers for Disease Control and Prevention formally recommends who should receive FDA-cleared vaccines.
The announcement by CDC director Dr. Rochelle Walensky came only hours after an advisory panel unanimously decided Pfizer’s shots should be opened to the 28 million youngsters in that age group.
The decision marks the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine.
Read:FDA paves way for Pfizer COVID-19 vaccinations in young kids
“As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Walensky said Tuesday night, in a statement.
In remarks earlier in the day, she said while the risk of severe disease and death is lower in young children than adults, it is real — and that COVID-19 has had a profound social, mental health and educational impact on youngsters, including widening disparities in learning.
“There are children in the second grade who have never experienced a normal school year,” Walensky said. “Pediatric vaccination has the power to help us change all of that.”
President Joe Biden called the decision “a turning point.”
“It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others,” he said in a statement. “It is a major step forward for our nation in our fight to defeat the virus.”
The American Academy of Pediatrics welcomed the decision as its members get ready to start the first injections into little arms, which the CDC said could begin “as soon as possible.” The 5- to 11-year-olds will receive two low doses, three weeks apart, of the vaccine made by Pfizer and its partner BioNTech -- the same schedule as everyone else, but using a smaller needle.
Pfizer over the weekend began shipping millions of the pediatric shots to states, doctors’ offices and pharmacies — in orange caps, to avoid mix-ups with purple-capped vials of adult vaccine.
Many parents have clamored for vaccine protection for youngsters so they can resume normal childhood activities without risking their own health — or fear bringing the virus home to a more vulnerable family member. But CDC’s advisers said they recognize many parents also have questions, and may be fearful of the vaccine because of rampant misinformation.
Members of the advisory panel said they want parents to ask about the shots — and understand that they’re far better than gambling that their child will escape a serious coronavirus infection. As for safety, more than 106 million Americans have safely gotten two doses of Pfizer’s full-strength shots — including more than 7 million 12- to 15-year-olds.
“I have vaccinated my kids,” said CDC adviser Dr. Helen Keipp Talbot of Vanderbilt University, saying she wouldn’t recommend something for other families unless she was comfortable with it for her own. “We have seen the devastation of this disease.”
In the U.S., there have been more than 8,300 coronavirus-related hospitalizations of kids ages 5 to 11, about a third requiring intensive care, according to government data. The CDC has recorded at least 94 deaths in that age group, with additional reports under investigation.
And while the U.S. has seen a recent downturn in COVID-19 cases, experts are worried about another uptick with holiday travel and as winter sends more activity indoors where it’s easier for the coronavirus to spread.
Pfizer’s study of 2,268 youngsters found the kid-size vaccine is nearly 91% effective at preventing symptomatic COVID-19 -- based on 16 diagnoses among kids given dummy shots compared to just three who got the real vaccination.
The FDA examined more children, a total of 3,100 who were vaccinated, in concluding the shots are safe. The younger children experienced similar or fewer reactions -- such as sore arms, fever or achiness -- than teens or young adults get after larger doses.
That study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. Regulators ultimately decided the benefits from vaccination outweigh the potential that younger kids getting a smaller dose also might experience that rare risk.
Some of CDC’s advisers said for some parents, deciding to get their children vaccinated may hinge on that small but scary risk.
“The risk of some sort of bad heart involvement is much higher if you get COVID than if you get this vaccine,” Dr. Matthew Oster, a pediatric cardiologist at Emory University, told the panel. “COVID is much riskier to the heart.”
Read: Pfizer says COVID-19 vaccine more than 90% effective in kids
Last week, FDA’s advisers struggled with whether every young child needed a vaccine. Youngsters hospitalized with COVID-19 are more likely to have high-risk conditions such as obesity or diabetes. But otherwise healthy children can get seriously ill, too, and the CDC’s advisers ultimately recommended the shots for all of them — even children who’ve already recovered from a bout of COVID-19.
CDC officials calculated that for every 500,000 youngsters vaccinated, between 18,000 and 58,000 COVID-19 cases — and between 80 and 226 hospitalizations — in that age group would be prevented, depending on the pandemic’s trajectory. And CDC officials noted that COVID-19 has caused more deaths in this age group than some other diseases, such as chickenpox, did before children were routinely vaccinated against them.
What about younger children? Pfizer is testing shots for babies and preschoolers and expects data around the end of the year. The similarly made Moderna vaccine also is being studied with young children. But the FDA still hasn’t cleared its use in teens, and the company is delaying its application for younger children pending that review.
A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds. But many that use the Pfizer-BioNTech vaccine are watching the U.S. decision, and European regulators just began considering the companies’ kid-size doses.
2 years ago
Global Covid cases top 232 million
The overall number of global Covid cases has now surged past 232 million, despite the ongoing mass inoculations in several countries.
According to Johns Hopkins University (JHU), the total case count and fatalities mounted to 232,306,848 and 4,755,859, respectively, on Tuesday morning.
The US has recorded 43,116,407 cases to date while more than 690,426 people have died so far from the virus in the country, as per the university data.
Read: Biden, McConnell get COVID-19 boosters, encourage vaccines
With more than 40 million doses of coronavirus vaccines available, US health authorities said they’re confident that there will be enough for both qualified older Americans seeking booster shots and the young children for whom initial vaccines are expected to be approved in the not-too-distant future, reports AP.
The spike in demand — expected following last week’s federal recommendation on booster shots — would be the first significant jump in months. More than 70 million Americans remain unvaccinated despite the enticement of lottery prizes, free food or gifts and pleas from exhausted healthcare workers as the average number of deaths per day climbed to more than 1,900 in recent weeks.
Brazil which has been experiencing a new wave of cases since January, registered 21,366,395 cases on Monday. Brazil's Covid death toll has also risen to 594,653.
India's Covid-19 tally rose to 33,678,786 on Monday, as 26,041 new cases were registered in 24 hours across the country, as per the federal health ministry data.
Besides, 276 deaths were recorded since Sunday morning, taking the death toll to 447,194.
Read: Turkey working on developing national Covid vaccine
Situation in Bangladesh
Covid-19 in Bangladesh claimed 25 more lives and infected 1,212 others in 24 hours till Monday morning.
The fresh cases were detected after testing 27,287 samples keeping the daily case positivity rate at 4.36 percent, said the Directorate General of Health Services (DGHS).
With this, the daily case positivity rate of Covid-19 in the country remained below 5 percent for the seventh consecutive day.
According to the World Health Organization (WHO), the daily case positivity rate of 5 percent or below for 14 days is considered safe for mass unlocking.
The fresh numbers reported on Monday took the total fatalities to 27,439 while the caseload mounted to 1,552,563, said the DGHS.
Read: Covid easing in Bangladesh, but it still kills 25 more
However, the mortality rate remained static at 1.77 percent.
The recovery rate remained unchanged at 97.43 percent, with the recovery of 1,202 more patients during the period.
So far, 1,512,681 people have recovered from the deadly virus infections in Bangladesh, the DGHS said.
3 years ago
Biden, McConnell get COVID-19 boosters, encourage vaccines
Seventy-eight-year-old Joe Biden and 79-year-old Mitch McConnell got their booster shots Monday, the Democratic president and the Republican Senate leader urging Americans across the political spectrum to get vaccinated or plus up with boosters when eligible for the extra dose of protection.
The shots, administered just hours apart on either end of Pennsylvania Avenue, came on the first workday after the Centers for Disease Control and Prevention and the Food and Drug Administration recommended a third dose of the Pfizer vaccine for Americans 65 and older and approved them for others with preexisting medical conditions and high-risk work environments.
Both leaders said that even though the booster doses provide more enduring protection against the virus, they weren’t the silver bullet to ending the pandemic.
Read: Quad on track to produce 1 bn vax doses in India: Biden
“Boosters are important, but the most important thing we need to do is get more people vaccinated,” Biden said.
Nearly 25% of eligible Americans aged 12 and older haven’t received a single dose of the vaccines. They are bearing the brunt of a months-long surge in cases and deaths brought about by the more transmissible delta variant of the virus that has killed 688,000 in the U.S. since the pandemic began.
“Like I’ve been saying for months, these safe and effective vaccines are the way to defend ourselves and our families from this terrible virus,” said McConnell, a polio survivor.
Biden got his first shot on Dec. 21 and his second dose three weeks later, on Jan. 11, along with his wife, Jill Biden. The first lady, who is 70, received her Pfizer booster dose in private at the White House on Monday afternoon, said her spokesperson, Michael LaRosa.
Read:Biden aims to enlist allies in tackling climate, COVID, more
“Now, I know it doesn’t look like it, but I am over 65 — I wish I — way over,” the president joked. “And that’s why I’m getting my booster shot today.”
Biden has championed booster doses since the summer as the U.S. experienced a sharp rise in coronavirus cases driven by the delta variant. While the vast majority of cases continue to occur among unvaccinated people, regulators pointed to evidence from Israel and early studies in the U.S. showing that protection against so-called breakthrough cases was vastly improved by a third dose of the Pfizer shot.
But the aggressive American push for boosters, before many poorer nations have been able to provide even a modicum of protection for their most vulnerable populations, has drawn the ire of the World Health Organization and some aid groups, which have called on the U.S. to pause third shots to free up supply for the global vaccination effort.
Biden said last week that the U.S. was purchasing another 500 million doses of the Pfizer vaccine — for a total of 1 billion over the coming year — to donate to less well-off nations.
Biden took questions from reporters about his vaccination experience and matters of the day as a military nurse injected the dose into his arm.
Read: Top doctors say not so fast to Biden’s boosters-for-all plan
The president said he did not have side effects after his first or second shots and hoped for the same experience with his third.
Vice President Kamala Harris, 56, received the Moderna vaccine, for which federal regulators have not yet authorized boosters — but they are expected to in the coming weeks. Regulators are also expecting data soon about the safety and efficacy of a booster for the single-dose Johnson & Johnson shot.
At least 2.66 million Americans have received booster doses of the Pfizer vaccine since mid-August, according to the CDC. About 100 million Americans have been fully vaccinated against COVID-19 through the Pfizer shot. U.S. regulators recommend getting the boosters at least six months after the second shot of the initial two-dose series.
3 years ago
COVID-19 vaccine boosters could mean billions for drugmakers
Billions more in profits are at stake for some vaccine makers as the U.S. moves toward dispensing COVID-19 booster shots to shore up Americans’ protection against the virus.
How much the manufacturers stand to gain depends on how big the rollout proves to be.
U.S. health officials late on Thursday endorsed booster shots of the Pfizer vaccine for all Americans 65 and older — along with tens of millions of younger people who are at higher risk from the coronavirus because of health conditions or their jobs.
Officials described the move as a first step. Boosters will likely be offered even more broadly in the coming weeks or months, including boosters of vaccines made by Moderna and Johnson & Johnson. That, plus continued growth in initial vaccinations, could mean a huge gain in sales and profits for Pfizer and Moderna in particular.
Read:Global leaders commit support for equitable access to Covid vaccines
“The opportunity quite frankly is reflective of the billions of people around the world who would need a vaccination and a boost,” Jefferies analyst Michael Yee said.
Wall Street is taking notice. The average forecast among analysts for Moderna’s 2022 revenue has jumped 35% since President Joe Biden laid out his booster plan in mid-August.
Most of the vaccinations so far in the U.S. have come from Pfizer, which developed its shot with Germany’s BioNTech, and Moderna. They have inoculated about 99 million and 68 million people, respectively. Johnson & Johnson is third with about 14 million people.
No one knows yet how many people will get the extra shots. But Morningstar analyst Karen Andersen expects boosters alone to bring in about $26 billion in global sales next year for Pfizer and BioNTech and around $14 billion for Moderna if they are endorsed for nearly all Americans.
Those companies also may gain business from people who got other vaccines initially. In Britain, which plans to offer boosters to everyone over 50 and other vulnerable people, an expert panel has recommended that Pfizer’s shot be the primary choice, with Moderna as the alternative.
Andersen expects Moderna, which has no other products on the market, to generate a roughly $13 billion profit next year from all COVID-19 vaccine sales if boosters are broadly authorized.
Potential vaccine profits are harder to estimate for Pfizer, but company executives have said they expect their pre-tax adjusted profit margin from the vaccine to be in the “high 20s” as a percentage of revenue. That would translate to a profit of around $7 billion next year just from boosters, based on Andersen’s sales prediction.
Read:India to restart Covid vaccine exports to COVAX, neighbours
J&J and Europe’s AstraZeneca have said they don’t intend to profit from their COVID-19 vaccines during the pandemic.
For Pfizer and Moderna, the boosters could be more profitable than the original doses because they won’t come with the research and development costs the companies incurred to get the vaccines on the market in the first place.
WBB Securities CEO Steve Brozak said the booster shots will represent “almost pure profit” compared with the initial doses.
Drugmakers aren’t the only businesses that could see a windfall from delivering boosters. Drugstore chains CVS Health and Walgreens could bring in more than $800 million each in revenue, according to Jeff Jonas, a portfolio manager with Gabelli Funds.
Jonas noted that the drugstores may not face competition from mass vaccination clinics this time around, and the chains are diligent about collecting customer contact information. That makes it easy to invite people back for boosters.
Drugmakers are also developing COVID-19 shots that target certain variants of the virus, and say people might need annual shots like the ones they receive for the flu. All of that could make the vaccines a major recurring source of revenue.
The COVID-19 vaccines have already done much better than their predecessors.
Pfizer said in July it expects revenue from its COVID-19 vaccine to reach $33.5 billion this year, an estimate that could change depending on the impact of boosters or the possible expansion of shots to elementary school children.
Read: Pfizer says COVID-19 vaccine works in kids ages 5 to 11
That would be more than five times the $5.8 billion racked up last year by the world’s most lucrative vaccine — Pfizer’s Prevnar13, which protects against pneumococcal disease.
It also would dwarf the $19.8 billion brought in last year by AbbVie’s rheumatoid arthritis treatment Humira, widely regarded as the world’s top-selling drug.
This bodes well for future vaccine development, noted Erik Gordon, a business professor at the University of Michigan.
Vaccines normally are nowhere near as profitable as treatments, Gordon said. But the success of the COVID-19 shots could draw more drugmakers and venture capitalists into the field.
“The vaccine business is more attractive, which, for those of us who are going to need vaccines, is good,” Gordon said.
3 years ago
Global leaders commit support for equitable access to Covid vaccines
The global leaders have pledged financing, dose donations, support for country readiness and delivery, and scale-up of global manufacturing to enable equitable access to Covid vaccines.
To improve access for the lower-income economies, the US will contribute an additional 500 million doses of Pfizer vaccine, to be delivered through COVAX, beginning in 2022. Sweden will provide an additional $243 million through 2021 and 2022.
New dose commitments from the European Union, including Italy and Spain, as well as Sweden, Denmark, and Japan mean further doses will be available to COVAX participants in 2021 and 2022.
Global leaders made the commitment while attending the Global Covid-19 Summit hosted by the US Thursday.
They underlined their commitment to ensuring equitable access to Covid vaccines for all countries through COVAX – noting that equitable access is essential to end the acute stage of the pandemic.
Building on the momentum and global solidarity generated over the past eighteen months by various commitments, including at summits organised by the European Commission, the G20 under the Saudi and Italian presidencies, the UK, including the G7 under its presidency, the US, and the prime minister of Japan, the summit saw further pledges made to COVAX and equitable access.
READ: Declare Covid vaccines as 'global public good': Hasina
Alongside these commitments, several countries pledged additional dose donations to be made available to countries around the world, including through COVAX, with Spain pledging an additional 7.5 million doses, Italy pledging an additional 30 million doses to be made available by the end of the year.
And Japan, which hosted the "One World Protected" Gavi COVAX AMC Summit in June 2021, pledging approximately 60 million doses.
Also, Denmark announced during the United Nations General Assembly this week that it would be doubling its dose donation commitment, bringing the total to 6 million doses pledged to be shared.
José Manuel Barroso, chair of the Gavi board, said this summit marks a major step forward in the global response against Covid and a major step forward for multilateralism.
Dr Tedros Adhanom Ghebreyesus, the director-general of the World Health Organisation, said if they are to meet the targets they have set of vaccinating 10% of the population of all countries by the end of this month, 40% by the end of 2021 and 70% by mid-next-year, they need to drastically scale up access to vaccines now.
Unicef Executive Director Henrietta Fore said with only 12% of the pledges made earlier this year turning into actual doses, low-income countries can no longer wait. "We urge dose-sharing countries to accelerate their donation plans."
READ: Conduct study to understand vaccine performances, suitability in Bangladesh: Experts
Dr Seth Berkley, CEO of Gavi, said with the rise of variants and the current gap in equitable access to Covid vaccines they must urgently vaccinate those most at risk everywhere in the world.
"We cannot afford further delays in getting vaccines to the most vulnerable – to do so will mean a continuation of this pandemic and its impact on all of our lives."
So far COVAX has delivered more than 300 million doses to 142 economies, and according to the latest forecast, approximately 1.2 billion doses will be available for the lower-income economies supported by the COVAX Advance Market Commitment (AMC) by the end of 2021.
This is enough to protect 20% of the population, or 40% of all adults, in all 92 AMC economies with the exception of India.
The key COVAX milestone of 2 billion doses released for delivery is now expected to be reached in the first quarter of 2022.
3 years ago
CDC panel grapples with who needs a COVID-19 booster shot
An influential panel of advisers to the Centers for the Disease Control and Prevention grappled Wednesday with the question of which Americans should get COVID-19 booster shots, with some members wondering if the decision should be put off for a month in hopes of more evidence.
The doubts and uncertainties suggested yet again that the matter of whether to dispense extra doses to shore up Americans’ protection against the coronavirus is more complicated scientifically than the Biden administration may have realized when it outlined plans a month ago for an across-the-board rollout of boosters. The rollout was supposed to have begun this week.
Much of the discussion at the meeting of the CDC’s Advisory Committee on Immunization Practices focused on the possibility of a scaled-back booster program targeted to older people or perhaps health care workers. But even then, some of the experts said that the data on whether boosters are actually needed, precisely who should get them and when was not clear-cut.
“What would be the downside” of simply waiting a month in hopes of more information? asked Dr. Sarah Long of Drexel University.
Read: Top doctors say not so fast to Biden’s boosters-for-all plan
The two-day meeting had been scheduled to resume on Thursday, but it was not immediately clear whether that would happen.
The meeting came days after a different advisory group — this one serving the Food and Drug Administration — overwhelmingly rejected a sweeping White House plan to dispense third shots to nearly everyone. Instead, that panel endorsed booster doses of the Pfizer vaccine only for senior citizens and those at high risk from the virus.
While the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death, immunity against milder infection seems to be dropping months after vaccination.
“I want to highlight that in September of 2021 in the United States, deaths from COVID-19 are largely vaccine-preventable with the primary series of any of the three vaccines available,” said CDC advisory panel member Dr. Matthew Daley, a researcher at Kaiser Permanente Colorado.
And the public must understand that no matter how good a COVID-19 vaccine is, when it comes to milder infections, “it is unlikely that we will prevent everything,” said Dr. Helen Keipp Talbot of Vanderbilt University.
Several panelists said another concern is the public confusion that could result if they recommend a booster only for certain recipients of the Pfizer vaccine. That could leave people vaccinated with Moderna or Johnson & Johnson shots wondering what to do.
The meeting was devoted to Pfizer booster shots only. Moderna’s application to dispense third doses is not as far along in the process. And a major U.S. study on whether mixing-and-matching booster doses is safe and effective isn’t finished.
Read: US panel backs COVID-19 boosters only for seniors, high-risk
Many experts are torn about the need for boosters because they see the COVID-19 vaccines working as expected, even amid the spread of the highly contagious delta variant. It is normal for virus-blocking antibodies to be highest right after vaccination and then wane over the following months.
“We don’t care if antibodies wane. You care what is the minimum” needed for protection, Long said.
Yet no one knows the antibody level threshold below which someone’s risk for infection suddenly jumps. Even then, the body has backup defenses.
Antibody production and even those backup defenses don’t form as robustly in older people. But it’s impossible to pinpoint the age at which that becomes a problem, CDC microbiologist Natalie Thornburg told the committee.
Ultimately the committee must decide who is considered at high enough risk for an extra dose.
CDC officials presented data from several U.S. studies, saying there is growing evidence of a decline in the effectiveness of both the Pfizer and Moderna vaccines in preventing new COVID-19 infections in some groups, most notably people 65 and older and health care workers who got shots early in the vaccination campaign.
There’s also a hint that at age 75, there may be some decline in protection against hospitalization. But the CDC said there is little information on waning immunity in younger people with chronic medical problems.
Some panelists also wondered about boosters for health care workers who can’t come to work if they get even a mild infection.
Read: Global vaccine disparity gets sharper amid talk of boosters
“We don’t have enough health care workers to take care of the unvaccinated. They just keep coming,” Talbot said.
Another question was how many months after the second shot the booster should be given. Scientists have talked about six months or eight months.
As for booster safety, serious side effects are exceedingly rare with the first two doses. And Pfizer pointed to 2.8 million booster doses given in Israel, mostly to people 60 and older, with fewer reports of annoying side effects like pain or fever with the third dose than with the earlier shots. There was one report of a rare risk, heart inflammation, that is sometimes seen in younger men.
In the U.S., more than 24,000 people who have volunteered for a CDC vaccine safety tracking system have reported getting an extra dose, and likewise have reported no red flags.
3 years ago
Pfizer says COVID-19 vaccine works in kids ages 5 to 11
Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek U.S. authorization for this age group soon — a key step toward beginning vaccinations for youngsters.
The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.
For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
Read: US assures Covid cooperation to continue as 1-mn doses of Pfizer's vaccine received
The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.
“I think we really hit the sweet spot,” said Gruber, who’s also a pediatrician.
Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids.
An outside expert said scientists want to see more details but called the report encouraging.
“These topline results are very good news,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. The level of immune response Pfizer reported “appears likely to be protective.”
Read: US regulators give full approval to Pfizer COVID-19 vaccine
Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what’s the right dose and that it works safely. Cuba last week began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.
3 years ago
University students must complete vaccine registration by Sept 27: Dipu Moni
All the university students must complete vaccine registration by September 27 so that syndicate and academic councils can decide to reopen their universities, said Education Minister Dipu Moni on Tuesday.
The minister said this after a virtual meeting on reopening universities with Vice-Chancellors, representatives of University Grants Commission (UGC), secretary for Secondary and Higher Education division, president of the national technical committee on Covid-19 and officials concerned.
Deputy Minister for Education Mohibul Hasan Chowdhury also attended the meeting.
According to a decision of the meeting, the teachers, students and officials of all the universities of the country will have to register for vaccination against Covid-19 by September 27.
3 years ago