COVID-19 vaccines
US experts wrestle with how to update COVID-19 vaccines
More than two years into the COVID-19 pandemic, U.S. health officials are beginning to grapple with how to keep the vaccines updated to best protect Americans from the ever-changing coronavirus.
On Wednesday, a panel of vaccine advisers to the Food and Drug Administration spent hours debating key questions for revamping the shots and conducting future booster campaigns. They didn't reach any firm conclusions.
The questions facing the experts included: How often to update the vaccines against new strains, how effective they should be to warrant approval and whether updates should be coordinated with global health authorities.
Last week, the FDA authorized a fourth dose of the Pfizer or Moderna vaccines for anyone 50 or older and for some younger people with severely weakened immune systems. It’s an effort to get ahead of another possible surge.
Also read: UN finds link between widening inequalities and vaccine access
But the FDA's vaccine chief Dr. Peter Marks acknowledged at the meeting “we simply can’t be boosting people as frequently as we are.” He called the latest booster update a “stopgap” measure to protect vulnerable Americans while regulators decide whether and how to tweak the current vaccines.
Marks cautioned that waning vaccine protection, new variants and colder weather in the fall could raise the risk of more surges.
“Our goal here is to stay ahead of future variants and outbreaks and ensure we do our best to reduce the toll of disease and death due to COVID-19,” said Marks, adding that he expects more meetings of the vaccine panel in coming months.
Some of the key questions the panel discussed:
HOW SHOULD THE U.S. DECIDE WHEN TO LAUNCH FUTURE ROUNDS OF BOOSTER SHOTS?
One area where experts appeared to agree is that vaccines should be judged on their ability to prevent severe disease that leads to hospitalization and death.
“We need to focus on the worst case, which is severe disease, and we need to change strains when we’re losing that battle,” said Dr. Mark Sawyer of the University of California, San Diego.
By that measure, the current vaccines have held up remarkably well.
During the last omicron-driven surge, two vaccine doses were nearly 80% effective against needing a breathing machine or death — and a booster pushed that protection to 94%, federal scientists recently reported.
But only about half of Americans eligible for a third shot have gotten one. And many experts said it was unsustainable to continue asking Americans to get boosted every few months.
A panelist from the Centers for Disease Control and Prevention suggested that the 80% protection from severe disease could become the standard for evaluating the vaccines.
"I think we may have to accept that level of protection and then use other alternative ways to protect individuals with therapeutics and other measures,” said Dr. Amanda Cohn, CDC's chief medical officer.
Presentations at the meeting by government health officials and independent researchers underscored the challenges of predicting when the next major COVID-19 variant might appear.
Trevor Bedford, a disease modeler with the Fred Hutchinson Cancer Research Center, said a major new strain like omicron could emerge anywhere from every 1.5 years to once a decade, based on currently available data. Given that unpredictability, researchers will need methods to quickly determine whether current vaccines work against emerging variants.
WHAT’S THE PROCESS FOR UPDATING VACCINES TO ADDRESS NEW VARIANTS?
All three COVID-19 vaccines now used in the U.S. are based on the original coronavirus version that emerged in late 2019. Updating the vaccines will be a complex task, likely requiring coordination between the FDA, manufacturers and global health authorities.
Also read:Pfizer asks US to allow 4th COVID vaccine dose for seniors
To speed the vaccines to market, the FDA relied on research shortcuts to judge effectiveness, mainly looking at their early impact on the immune system's antibody levels. A number of panelists said Wednesday they wanted more rigorous data from studies that track patients over time to see who gets sick or dies.
But that approach would likely be too time consuming.
“We’re looking at a conundrum here in that it’s going to be hard to generate all the data we want in short order when a new variant emerges,” said Dr. Ofer Levy of Harvard Medical School.
A representative for the U.S. Biomedical Advanced Research and Development Authority laid out the narrow window that manufacturers could face to reformulate, study and mass produce an updated vaccine by September.
“If you’re not on your way to a clinical trial by the beginning of May, I think it’s going to be very difficult to have enough product across manufacturers to meet demand,” said Robert Johnson, deputy assistant secretary of BARDA.
The process for updating annual flu vaccines offers one possible model, as laid out by a representative from the World Health Organization.
Twice a year, WHO experts recommend updates to flu vaccines to target emerging strains. The FDA then brings those recommendations to its own vaccine panel, which votes on whether they make sense for the U.S., setting the stage for manufacturers to tweak their shots and begin mass production.
But COVID-19 hasn’t yet fallen into a predictable pattern like the flu. And as the coronavirus evolves, different strains may become dominant in different regions of the world.
Several experts said they would need more meetings with more data and proposals from the FDA to decide on a strategy.
“We’ve never been here before. We’re all working together to do the best we can and it’s very complex,” said Oveta Fuller of the University of Michigan's Medical School.
2 years ago
Why are so many vaccinated people getting COVID-19 lately?
A couple of factors are at play, starting with the emergence of the highly contagious omicron variant. Omicron is more likely to infect people, even if it doesn't make them very sick, and its surge coincided with the holiday travel season in many places.
People might mistakenly think the COVID-19 vaccines will completely block infection, but the shots are mainly designed to prevent severe illness, says Louis Mansky, a virus researcher at the University of Minnesota.
And the vaccines are still doing their job on that front, particularly for people who've gotten boosters.
Also read: CDC mulling COVID test requirement for asymptomatic: Fauci
Two doses of the Pfizer-BioNTech or Moderna vaccines or one dose of the Johnson & Johnson vaccine still offer strong protection against serious illness from omicron. While those initial doses aren’t very good at blocking omicron infection, boosters — particularly with the Pfizer and Moderna vaccines — rev up levels of the antibodies to help fend off infection.
Omicron appears to replicate much more efficiently than previous variants. And if infected people have high virus loads, there's a greater likelihood they'll pass it on to others, especially the unvaccinated. Vaccinated people who get the virus are more likely to have mild symptoms, if any, since the shots trigger multiple defenses in your immune system, making it much more difficult for omicron to slip past them all.
Also read: US children hospitalized with COVID in record numbers
Advice for staying safe hasn't changed. Doctors say to wear masks indoors, avoid crowds and get vaccinated and boosted. Even though the shots won’t always keep you from catching the virus, they'll make it much more likely you stay alive and out of the hospital.
2 years ago
Bangladesh gets more AstraZeneca doses from France
The government of France has donated 1,197,600 doses of the AstraZeneca vaccine to Bangladesh under the Covax arrangement.
The vaccine support from France came as a gesture of solidarity to the friendly country Bangladesh's fight against Covid-19 pandemic.
Read: Japan to provide more AstraZeneca vaccines to Bangladesh Dec 21
An Emirates flight carried the consignment of 1,197600 doses of AstraZeneca doses that arrived at Shahjalal International Airport on Sunday.
This is in addition to a consignment of 2.06 million doses of the AstraZeneca vaccine French gave to Bangladesh on November 29, 2021 through the Covax facility.
Read:UK donates over 4mn AstraZeneca jabs to Bangladesh
The government of France has made the sharing of Covid-19 vaccines one of its priorities, in solidarity with the countries hit by the pandemic and in order to help accelerate vaccination coverage on a global scale.
3 years ago
Resource for journalists around the world on COVID-19 vaccines
If you're a fact checker or a journalist, we're here to help you find the information and experts you need for your story.
The COVID-19 Vaccine Media Hub (https://covidvaccinehub.org/) is a dedicated global resource for journalists and fact checkers wanting access to evidence-based information on COVID-19 vaccines with material available in multiple languages.
The Hub collates information on COVID-19 vaccines from trustworthy sources, including explainers, summaries of the latest research, expert comments, and online media briefings.
Read: World-class vaccine institute to be set up in Bangladesh: PM
The project is a combined effort, with contributions from Science Media Centres and other not-for-profit organisations in Australia, the UK, Germany, Taiwan, Africa, Canada, the US, Spain and New Zealand. A full list of contributing organisations is available on the hub.
Journalists can also use the hub to sign up to a regular alert and use the network to ask questions about vaccines in different countries or to ask for help with a story.
This collaboration was made possible through a grant from the Google News Initiative. All organisations involved are independent and are focused on helping journalists and factcheckers find accurate information and credible experts on COVID-19 vaccines.
Read: Bangladesh can produce Covid vaccine, let us do it: PM
For further information, please visit ( https://covidvaccinehub.org/ ) or contact the Australian Science. Media Centre via email [email protected] or +61 8 7120 8666.
ABOUT US: The Australian Science Media Centre is an independent, not-for-profit Centre working to enhance the media's coverage of science, for the benefit of all. We provide the evidence and experts when science hits the headlines and administer the breaking science news portal for our region – scimex.org. The Centre is part of a global network of science media centres.
SOURCE: Covid Vaccine Media Hub
3 years ago
Are COVID-19 boosters the same as the original vaccines?
Are COVID-19 boosters the same as the original vaccines?
Yes, COVID-19 boosters use the same recipe as the original shots, despite the emergence of the more contagious delta variant. The vaccines weren't tweaked to better match delta because they're still working well.
Read:Covid vaccine: India-made Covaxin approved by WHO for emergency use
The vaccines work by training your body to recognize and fight the spike protein that coats the coronavirus and helps it invade the body’s cells. Delta’s mutations fortunately weren’t different enough to escape detection.
The increased protection you might get from a booster adjusted to better match the delta or other variants would be marginal, says Dr. Paul Goepfert, director of the Alabama Vaccine Research Clinic at the University of Alabama at Birmingham.
Manufacturing doses with a new formula would have also delayed the rollout of boosters.
Read: Indonesia first to greenlight Novavax COVID-19 vaccine
Moderna and Pfizer are studying boosters tweaked for the delta and other variants to be ready if one's ever needed. Health authorities would have to decide if and when a vaccine formula swap would be worthwhile.
“What we don’t know,” Goepfert noted, “is if you have a delta vaccine compared to the regular vaccine, does it actually work better in preventing transmission or asymptomatic infection?”
The U.S. has authorized booster doses of the Pfizer, Moderna and Johnson & Johnson vaccines for certain people, and a few other countries also are using boosters of those shots or other COVID-19 vaccines.
3 years ago
US financing body, Biological E finalise agreement to expand COVID manufacturing capabilities in India
In a move towards fulfilling the commitment set by the "Quad" leaders, the U.S. International Development Finance Corporation and Biological E. Limited unveiled the expansion of Biological E.'s vaccine manufacturing facility in Hyderabad on Monday.
According to a press release by the US Mission India, the facility finalised a U.S. government financing arrangement formalizing USD 50 million to expand the company's capacity to produce COVID-19 vaccines, reports ANI.
Read: Buoyant stock market takes India's unique investor base past 50 million
This is being done to bolster near-term COVID-19 response efforts. It will also benefit long-term global health in India and throughout the Indo-Pacific region, said to the press release.
Chief Operating Officer, DFC, David Marchick said, "DFC's partnership with Biological E will support capacity for production of more than one billion vaccine doses by the end of 2022 for India and for developing countries around the world."
The managing director of Biological E. Limited, Mahima Datla expressed her pleasure for the financial support from the US government which was announced at the Quad Summit in March 2021.
"This investment will not only help us augment our capacity to produce more COVID-19 vaccines, but also help the global community that has been relentlessly fighting against the spread of the COVID-19 pandemic," said Datla said.
Read: Facebook dithered in curbing divisive user content in India
The release further said that DFC's investment in Biological E. Limited is part of the agency's Global Health and Prosperity Initiative, which is focused on supporting the global response to the COVID-19 pandemic and strengthening health resilience in developing countries.
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
Declare Covid vaccines as 'global public good': Hasina
Prime Minister Sheikh Hasina has reiterated her call to global leaders to declare Covid-19 vaccines as 'global public good' and allow the developing countries and LDCs to produce vaccines that have the capacity.
“For effective global vaccination, Covid-19 vaccines need to be declared as ‘global public good’. To guarantee universal access, local production of vaccines by the developing countries and LDCs that have the capacity must be allowed,” she said.
The Prime Minister made the call in her prerecorded speech for the ‘White House Global Covid-19 Summit: Ending the Pandemic and Building Back Better Health Security to prepare For the Next’.
US President Joe Biden convened the Summit.
Sheikh Hasina said Bangladesh took a three-fold approach to fight the pandemic.
Those are: Saving lives by allocating adequate medical facilities, equipment, life-saving drugs and resources; Supporting the livelihoods of citizens, especially the most vulnerable groups; and Recovering economic activities back on track as quickly as possible.
Read: Hasina woos US investors; offers attractive facilities
3 years ago
Unvaccinated 11 times more likely to die from Covid: CDC
New US studies released Friday show the Covid-19 vaccines remain highly effective against hospitalisations and death even as the highly contagious delta variant swept the country.
One study tracked over 600,000 Covid-19 cases in 13 states from April through mid-July. As delta surged in early summer, those who were unvaccinated were 4.5 times more likely than the fully vaccinated to get infected, over 10 times more likely to be hospitalised and 11 times more likely to die, according to the US Centers for Disease Control and Prevention (CDC).
"Vaccination works," Dr Rochelle Walensky, CDC's director, told a White House briefing Friday.
But as earlier data has shown, protection against Covid infection is slipping: It was 91% in the spring but 78% in June and July, the study found.
So-called "breakthrough" cases in the fully vaccinated accounted for 14% of hospitalisations and 16% of deaths in June and July, about twice the percentage as earlier in the year.
An increase in those percentages is not surprising: No one ever said the vaccines were perfect and health experts have warned that as more Americans get vaccinated, they naturally will account for a greater fraction of the cases.
Read: Global vaccine disparity gets sharper amid talk of boosters
Rochelle said Friday that well over 90% of people in US hospitals with Covid are unvaccinated.
The CDC released two other studies Friday that signalled hints of waning protection for older adults. One examined Covid hospitalisations in nine states over the summer and found protection for those 75 and older was 76% compared to 89% for all other adults. And in five Veterans Affairs medical centres, protection against Covid hospitalisations was 95% among 18- to 64-year-olds compared to 80% among those 65 and older.
It is not clear if the changes seen over time are because immunity is waning in people first vaccinated many months ago, that the vaccine is not quite as strong against delta – or that much of the country abandoned masks and other precautions just as delta started spreading.
But the US health authorities will consider this latest real-world data as they decide if at least some Americans need a booster, and how soon after their last dose. Next week, advisers to the Food and Drug Administration will publicly debate Pfizer's application to offer a third shot.
3 years ago
India's Modi to unveil $1.35 trillion infrastructure plan
India will soon launch a $1.35 trillion national infrastructure plan that will boost the country’s economy, Prime Minister Narendra Modi announced Sunday as part of independence day celebrations, reports The Washington Post.
Wearing a flowing bright saffron-colored turban, Modi addressed the nation from New Delhi’s 17th century Mughal-era Red Fort to mark the 74th anniversary of India’s independence from British rule. He said the infrastructure plan will create job opportunities for millions of Indian youth.
Read:UAE flights: Indian Embassy working with authorities to address vaccination concerns, says envoy
“It will help local manufacturers turn globally competitive and also develop possibilities of new future economic zones in the country,” he said.
India’s economy, pummeled by the coronavirus pandemic, contracted 7.3% in the fiscal year that ended in March. Economists fear there will be no rebound similar to the ones seen in the U.S. and other major economies.
In his 90-minute speech, Modi also listed his government’s achievements since 2014 and hailed India’s coronavirus vaccination campaign.
“We are proud that we didn’t have to depend on any other country for COVID-19 vaccines. Imagine what would have happened if India didn’t have its own vaccine,” he said.
India has given more than 500 million doses of vaccines but its vaccination drive has been marred by its slow pace. About 11% of eligible adult Indians have been fully vaccinated so far.
Modi also said India was committed to meeting targets for the reduction of its carbon footprint. He said his government would invest more in electric mobility, solar energy and “green hydrogen” — which does not emit carbon dioxide — as part of its goal to make India energy independent by 2047.
Modi began his speech by praising India’s athletes who took part in the recently concluded Tokyo Olympics. India won one gold, two silver and four bronze medals at the games.
Read:Over 2,000 evaluated as landslide blocks India river
India celebrates its Independence Day a day after its neighbor Pakistan. The two separate states came into existence as a result of the bloody partition of British India in 1947.
The process sparked some of the worst communal violence the world has seen and left hundreds of thousands dead. It triggered one of the largest human migrations in history and some 12 million people fled their homes.
On Saturday, Modi announced that August 14 will be observed as Partition Horrors Remembrance Day.
3 years ago