COVID-19 vaccine
Pfizer calls upon global health leaders, orgs to join ‘Accord for a Healthier World’
Pfizer has called upon the global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap and help create a healthier world for 1.2 billion people.
Pfizer Inc. (NYSE: PFE) on Wednesday launched ‘An Accord for a Healthier World.’ This groundbreaking initiative aims to provide all of Pfizer’s patented, high-quality medicines and vaccines available in the U.S. or the European Union on a not-for-profit basis to 1.2 billion people in 45 lower-income countries.
The Accord seeks to greatly reduce the health inequities that exist between many lower-income countries and the rest of the world.
“As we learned in the global COVID-19 vaccine rollout, supply is only the first step to helping patients. We will work closely with global health leaders to make improvements in diagnosis, education, infrastructure, storage and more. Only when all the obstacles are overcome can we end healthcare inequities and deliver for all patients,” said Pfizer Chairman and Chief Executive Officer Albert Bourla.
Also read: Pfizer says 3 COVID shots protect children under 5
The Accord countries include all 27 low-income countries as well as 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the last ten years, said a media release received from Switzerland.
Pfizer will work with healthcare officials in Rwanda, Ghana, Malawi, Senegal and Uganda to identify early insights and opportunities to ensure all medicines and vaccines can reach those in need.
This will include expertise to support diagnosis, healthcare professional education and training along with supply chain management and other infrastructure enhancements.
Learnings from these five countries will be applied to support the roll out for the remaining forty countries.
Pfizer will also collaborate with Accord participants to identify quick and efficient regulatory pathways and procurement processes to reduce the longer amount of time it can take to make new medicines and vaccines available in these countries.
Under the Accord, Pfizer has committed to provide 23 medicines and vaccines that treat infectious diseases, certain cancers, and rare and inflammatory diseases.
As Pfizer launches new medicines and vaccines, those products will also be included in the Accord portfolio on a not-for-profit basis.
The Accord also aims to establish faster access to Pfizer’s future pipeline medicines and vaccines on a not-for-profit-basis to the 45 countries, particularly those that treat diseases that disproportionately impact global health.
To further this commitment, Pfizer, with funding from the Bill & Melinda Gates Foundation, is advancing work on the development of vaccine candidates for the prevention of Group B Streptococcus (GBS), which is a leading cause of stillbirth and newborn mortality in low-income countries.
Also read: CDC urges Pfizer booster for children ages 5 to 11
They are also discussing opportunities to support Respiratory Syncytial Virus (RSV) vaccine development, another maternal vaccine.
“Everyone, no matter where they live, should have the same access to innovative, life-saving drugs and vaccines,” said Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation. “The Accord for a Healthier World could help millions more people in low-income countries get the tools they need to live a healthy life. Pfizer is setting an example for other companies to follow.”
Pfizer says 3 COVID shots protect children under 5
Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday. Pfizer plans to give the data to U.S. regulators later this week in a step toward letting the littlest kids get the shots.
The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases once again are rising. The 18 million tots under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
The Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to begin offering two kid-sized shots by summer.
Pfizer has had a bumpier time figuring out its approach. It aims to give tots an even lower dose — just one-tenth of the amount adults receive — but discovered during its trial that two shots didn’t seem quite strong enough for preschoolers. So researchers gave a third shot to more than 1,600 youngsters — from age 6 months to 4 years — during the winter surge of the omicron variant.
Also read: CDC urges Pfizer booster for children ages 5 to 11
In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, revving up tots’ levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.
Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
The companies already had submitted data on the first two doses to the FDA, and BioNTech’s CEO, Dr. Ugur Sahin, said the final third-shot data would be submitted this week.
“The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” he said in a statement.
What’s next? FDA vaccine chief Dr. Peter Marks has pledged the agency will “move quickly without sacrificing our standards” in evaluating tot-sized doses from both Pfizer and Moderna.
The agency has set tentative dates next month for its scientific advisers to publicly debate data from each company.
Also read: WHO recommends Pfizer's Covid pill Paxlovid
Moderna is seeking to be the first to vaccinate the littlest kids. It submitted data to the FDA saying tots develop high levels of virus-fighting antibodies after two shots that contain a quarter of the dose given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during the omicon surge, much like for adults who’ve only had two vaccine doses.
Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults.
The FDA is expected to review Moderna’s data on both the youngest age group, plus its study of teens and elementary-age children. Other countries already have expanded Moderna’s shot to kids as young as 6.
While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. And the omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge.
It’s not clear how much demand there will be to vaccinate the youngest kids. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that age group have gotten the recommended initial two doses. Last week, U.S. health authorities said elementary-age children should get a booster shot just like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.
UNICEF finds Bangladesh as Covid-19 vaccine success story
UNICEF has listed Bangladesh, Peru, Vietnam and the Philippines as "Covid-19 Vaccine Success Stories" in their recent report, noting that Bangladesh's vaccination rate has risen sharply.
When the first COVID-19 vaccines supplied by COVAX touched down in Bangladesh’s capital, Dhaka, in June 2021, less than four per cent of all adults were fully vaccinated, said UNICEF.
Also read: Help all reach vaccination targets, Hasina urges COVAX summit
Fast forward less than a year and that number has risen dramatically, said the UN agency, adding that by the beginning of April, 67 per cent of the population had received two doses.
Bangladesh has advanced eight notches to rank 5th out of 121 countries across the globe on Nikkei’s Covid-19 Recovery Index.
Of the other South Asian countries in the list, Nepal ranked 6th, Pakistan 23rd, Sri Lanka 31st, and India were 70th.
With a score of 80 on the index, Bangladesh ranked only below Qatar, the UAE, Cambodia and Rwanda in the latest edition of the index published recently.
COVAX has played a crucial role in that achievement. More than half of all the COVID-19 vaccines delivered to Bangladesh last year were through the programme, according to UNICEF.
Political priority at the highest level spearheaded by Prime Minister Sheikh Hasina herself; continuous diplomatic efforts to acquire sufficient amount of vaccines from bilateral as well as multilateral sources and an established capacity, in terms of infrastructure and human resources, to roll out large-scale nationwide immunization programmes are mainly three factors enabled Bangladesh to pull of this amazing feat, said Shah Ali Farhad, a former special assistant to the Prime Minister, while sharing his observation in a Facebook post.
Also read: 2nd round of mega Covid vaccination drive extended until April 3: Health Minister
Young volunteers in Bangladesh have played an important role in making sure those shots get to people’s arms, UNICEF said.
“They’ve been reaching out to communities to amplify the message that COVID-19 vaccines are safe and available.”
Mukta is one of those volunteers and has been driven by a desire to help other people during the pandemic and so she joined UNICEF as a volunteer.
Mukta has been going door to door, often talking to elderly people, families living in slums, and those who don’t have access to a mobile phone or the internet.
“I’ve seen so many vulnerable people,” says Mukta. “I enjoy going to people’s homes and raising awareness about vaccination. I love helping them.”
FDA restricts J&J’s COVID-19 vaccine due to blood clot risk
U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.
The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine.
FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine.
Also read:Moderna seeks FDA authorization for 4th dose of COVID shot
“If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that-- compared to no vaccine-- this is still a better option.”
The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.”
The FDA authorized J&J’s shot in February last year for adults 18 and up.
The vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.
In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J’s because of its safety issues.
As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was roughly 1 per million shots, according to Marks.
Marks said the FDA spent extra time analyzing the problem to be sure it wasn’t connected to a separate issue, such as women taking birth control medications that raise their risk of clotting.
The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the side effect.
Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.
A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”
Also read: In reversal, FDA puts brakes on COVID shots for kids under 5
The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare ri sk — as long as recipients were warned.
COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. Clots form in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.
The New Brunswick, New Jersey-based company announced last month that it didn’t expect a profit from the vaccine this year and was suspending sales projections.
The rollout of the company’s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.
Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barré syndrome.
Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 17 million Americans got the J&J shot.
India extends COVID-19 boosters to all adults; some must pay
India began offering booster doses of COVID-19 vaccine to all adults on Sunday but limited free shots at government centers to front-line workers and people over age 60.
The doses, which India is calling a “precautionary” shot instead of a booster, are available to people nine months after they receive their second jab, the Health Ministry said in a statement Friday. Those outside the two priority categories will need to pay for the shots at privately run facilities, the ministry said.
Also read: India soldier killed, 4 workers injured in Kashmir attacks
Unlike other countries, where many people receive a different vaccine as a booster, most Indians have received the same type — in most cases the AstraZeneca vaccine produced by India’s Serum Institute, the world’s largest vaccine maker. It accounts for nearly 90% of all doses that have been administered in India, even though emergency approvals have been given for eight vaccines.
On Saturday, the Serum Institute of India said it has cut the price of its AstraZeneca vaccine from $7.90 a dose to $2.96 for private hospitals.
India has so far vaccinated about 96% of those aged 15 years and older with at least one COVID-19 vaccine dose, while about 83% have received both shots, according to official data.
India’s booster program started in January when healthcare and front-line workers along with people over age 60 with health problems were allowed to receive shots.
Also read: Nepal-India cross-border railway to resume service
India has recorded a steep decline in coronavirus cases in recent weeks, with the Health Ministry reporting 1,054 cases in the latest 24 hours.
Help all reach vaccination targets, Hasina urges COVAX summit
Prime Minister Sheikh Hasina on Friday called upon the development partners to increase their contributions and vaccines to COVAX Advance Market Commitment (AMC) for helping all countries reach vaccination targets as some still remain far behind.
“I call upon all stakeholders to work together to help reach vaccination targets in all countries. I also urge the development partners to increase their contributions and vaccines to COVAX AMC,” she said.
She made the plea in a video statement at COVAX Advance Market Commitment (AMC) Summit organised by Germany and GAVI.
Also read: 50-yrs of Bangladesh Scouts: PM releases commemorative stamp
Hasina reiterated that Covid vaccines should be considered a global public good.
“Unfortunately, there are some countries who still remain far from achieving their vaccination targets. These countries deserve special attention and support from the international community,” she said.
She also ensured the world that Bangladesh is ready to do its part to ensure vaccine equity and committed to working always with GAVI and Covax AMC.
The prime minister said that COVID-19 pandemic has reinforced the need for international cooperation to respond effectively to public health emergencies.
In this connection, she said that the COVAX Facility has offered a global platform for the purpose.
“We must support this platform with necessary resources and expertise to deal with future pandemics,” she said.
The PM said that the impact of the pandemic could have been devastating in Bangladesh if the country did not have a strong healthcare system.
“Throughout the pandemic, we were able to keep the infection at tolerable level and now we see a drastic fall in the infection,” she said.
So far, the prime minister said that Bangladesh has vaccinated more than 90 percent of the target population at free of cost.
Also read: PM calls for enhancing digital security
“Our longstanding partnership with GAVI has been critical in achieving this success,” she added.
She also sought continued support from the COVAX AMC mechanism.
German Chancellor Olaf Scholz, Indonesian President Joko Widodo, President of Senegal Macky Sall and Chair of Gavi Board Prof. José Manuel Barroso delivered statements at the opening session, while Japan’s Prime Minister Fumio Kishida, US Secretary of State Antony J. Blinken, Tunisia’s Prime Minister Najla Bouden and UN Secretary General António Guterres also delivered video messages.
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.
Govt seeks WHO nod for vaccinating children aged 5 and above: Health Minister
In an effort to contain the spread of Covid-19, vaccination for primary school students aged five and above will start soon after WHO approval, said Health Minister Zahid Maleque on Monday.
“We have asked the Education Ministry to prepare a list of the students. We also have contacted the World Health Organisation for its approval,” he told reporters after an emergency on nationwide vaccination situation at Bangladesh Secretariat.
The start of the drive for vaccinating primary school students depends on WHO approval, he said in reply to a question.
Besides, the mega vaccination drive for administering second dose will begin on March 28 and will continue till March 30.
Also read: Bagerhat's shining success in vaccinating students
Some 2.25 crore people are likely to receive the second dose during the mega drive, he said.
Maleque said 22 crore doses of Covid vaccines so far have been administered in the country covering 75 per cent of the population.
An amount of Tk 40,000 crore has been spent for purchasing and administering covid doses, he added.
Also read: No decision yet on vaccinating the under-18: DGHS
Since the inauguration of the mass inoculation drive in Bangladesh on February 7 last year, some 8,68,44,218 people have been fully vaccinated with two shots and12,54,90,996 people received their first doses till Sunday (March 6).
Besides, 42,53,378 people have received booster doses, the minister said.
Russia-Ukraine War: Vaccine manufacturer braces for complications
A South Korean pharmaceutical company manufacturing Russia’s COVID-19 vaccine says it's bracing for business complications as the U.S.-led West escalates sanctions against Russia over the invasion of Ukraine.
Recently expanded U.S. sanctions include targeted measures against the Russian Direct Investment Fund, a sovereign wealth fund run by a close ally of President Vladimir Putin that globally markets the Sputnik vaccines.
Read:Ukrainian passport holders can seek UAE visas
Kim Gi-young, an official from Seoul-based GL Rapha, said the sanctions won’t directly impede its production of the shots as the measures aren’t aimed at essential medical supplies.
However, the company is concerned about potential problems rising from the financial side as South Korea joins the United States and many European countries in a move to cut off key Russian banks from global payment systems.
“Right now, we are watching how the situation develops,” Kim said.
GL Rapha has so far produced 5 million shots of the single-dose Sputnik Light vaccine, but none of them have been used so far as Russia continues to delay rollout plans, Kim said.
Read:Indian students in Ukraine in fear as Russian invasion grows
GL Rapha also has an agreement with RDIF to produce 150 million shots of the two-dose Sputnik V and is participating in a consortium of South Korean companies that has been contracted to produce another 500 million doses of Sputnik V, but these shots haven’t been produced yet.
RDIF has reportedly criticized the U.S. sanctions and said the measures would slow its promotion of Sputnik V.
US donates another 10mn doses of Pfizer’s vaccine
The United States has donated another 10 million (1 crore) doses of Pfizer’s COVID-19 vaccine to Bangladesh via COVAX, sustaining the effort to expand vaccinations across the country.
This latest donation from the American people makes Bangladesh the largest recipient of US-donated COVID-19 vaccines among all countries worldwide, with more than 61 million (6.1 crore) doses delivered to date, said the US Embassy in Dhaka on Monday.
These ongoing donations of Pfizer vaccines are part of the broader commitment by the United States to lead the global COVID-19 response by providing one billion doses of Pfizer vaccine around the world—free of charge—through 2022.
This latest donation of Pfizer doses underscores the partnership between the two countries and the generosity of the American people in donating more COVID-19 vaccines to Bangladesh than to any other country in the world, said U.S. Embassy Chargé d’Affaires Helen LaFave.
Also read: Dhaka calls for sharing technology, know-how of Covid-19 vaccine production
"More importantly, it reflects the work of the Government of Bangladesh and all partners involved in the rapid scale-up of the vaccination campaign to get shots in arms safely and efficiently."
The United States says it continues to work closely with Bangladesh to support every facet of the national COVID-19 vaccination campaign.
The United States has provided training to over 9,000 healthcare providers and volunteers on proper vaccination management, supported cold-chain storage and transportation, and assisted with targeted campaigns to vaccinate students and people in hard-to-reach communities.
The U.S. has also contributed over $131 million in COVID-related development and humanitarian assistance through the U.S. Agency for International Development (USAID), the U.S. Department of Defense, the U.S. Department of State, and the U.S. Centers for Disease Control and Prevention.
Also read: US donates 6mn more Pfizer vaccine doses to Bangladesh
This assistance has saved lives and treated individuals infected with COVID-19, strengthened testing capacity and monitoring, enhanced case management and infection prevention and control practices, and improved supply chain and logistics management systems.