coronavirus vaccine
European regulators OK Pfizer vaccine for children 12-15
The European Medicines Agency on Friday recommended that the use of the coronavirus vaccine made by Pfizer and BioNTech be expanded to children ages 12 to 15, a decision that offers younger and less at-risk populations across the continent access to a COVID-19 shot for the first time.
The vaccine was the first one granted authorization across the European Union when it was licensed for use in anyone 16 and over in December. So far, about 173 million doses of the shot have been administered in the 27-nation bloc, about three quarters of the total given.
“Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” said Marco Cavaleri, who heads the EMA body that reviewed the vaccine.
The EU regulator had received the necessary data to authorize the vaccine for younger teens and found it to be highly effective against infection, he said.
Also read: Bangladesh approves emergency use of Pfizer vaccine
In a study involving 2,000 adolescents in the United States, none of those who received the vaccine got COVID-19, compared with 16 in a control group who received a placebo, said Cavaleri.
“The vaccine was well tolerated and the side effect in this age group were very much similar (to) what we’ve seen in young adults and not raising major concern at this point in time,” he added.
The EMA decision needs to be rubber-stamped by the European Commission, and individual national regulators must decide whether the vaccine will be administered to children under 16.
The recommendation follows similar decisions by regulators in Canada and the U.S. last month, as rich countries slowly approach their vaccination targets for adults and look to immunize as many people as possible.
Also read: Britain yet to decide on Pfizer offer to vaccinate Olympians
Researchers will continue to monitor the shot’s long-term protection and safety in the children for another two years.
Most COVID-19 vaccines worldwide have been authorized for adults, who are at higher risk of severe disease and death from the coronavirus. But vaccinating children of all ages could be critical to stopping outbreaks, since some research has shown older children may play a role in spreading the virus even though they don’t typically fall seriously ill.
In the U.S., children represent about 14% of the country’s coronavirus cases and at least 316 have died, according to the American Academy of Pediatrics. Doctors have also identified a rare inflammatory syndrome in a very small proportion of children sickened by COVID-19.
Immunizing children against COVID-19 might also give authorities more confidence to reopen schools, as getting children to wear masks and engage in social distancing has been challenging at times.
Also read: Pfizer COVID-19 shot expanded to US children as young as 12
But the World Health Organization has criticized rich countries for moving on to vaccinate their younger and less at-risk populations, saying that the extremely limited number of COVID-19 vaccines should instead be shared with poor countries so they too can protect their health workers and those most vulnerable.
“I understand why some countries want to vaccinate their children and adolescents, but right now I urge them to reconsider and to instead donate vaccines to COVAX,” WHO chief Tedros Adhanom Ghebreyesus said earlier this month, referring to the U.N.-backed initiative to distribute vaccines fairly. Of the more than 1 billion COVID-19 shots administered globally, fewer than 2% have gone to poor countries.
Other vaccine makers also are studying whether their shots are safe and effective in children. Earlier this week, Moderna Inc. said its shot strongly protects children as young as 12; it said it would submit a request for emergency use authorization to the U.S. Food and Drug Administration next month. Another U.S. company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds.
Both Moderna and Pfizer-BioNTech have been testing their vaccines in children from age 11 down to six months; they get a lower dose than what teens and adults receive. China’s Sinovac has also submitted early data to the country’s regulators, hoping to prove its vaccine is safe in children as young as 3.
Bangladesh approves emergency use of Pfizer vaccine
The government of Bangladesh has approved the emergency use of Pfizer Covid-19 vaccine in the country.
Directorate General of Drug Administration (DGDA) issued a press release in this regard on Thursday.
This is the fourth Covid-19 vaccine approved for emergency use in Bangladesh.
Recently two other vaccines , Sputnik V produced by Generium Joint Stock Company of Russia, and Sinopharm produced by Beijing Institute of Biological Products Co. Ltd of China got approval of DGDA for emergency use in Bangladesh.
Earlier on January 7, DGDA approved the emergency use of Covishield vaccine, also known as SARS Cov-2 AZD1222, Oxford/ Astra zeneca vaccine, produced by Serum Institute of India.
Earlier on May 18, Health Minister Zahid Maleque said that the country will get at least 106,000 doses of the Pfizer vaccine under the Covax facility.
The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity, according to a BBC report.
The US Food and Drug Administration on Wednesday authorized storage of Pfizer Covid-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available.
Bangladesh records lowest Covid deaths in over two months
Bangladesh logged 17 more Covid-related deaths in 24 hours until Wednesday morning, the lowest number in 68 days.
The country saw 16 Covid-19 deaths on March 18 last.
Besides, 1,497 new cases were recorded taking the total caseload to 7,93,693, said a handout of the Directorate General of Health Services (DGHS).
The Covid-19 positivity rate declined to 9.11 percent from Tuesday’s 10.08 percent while the mortality rate remained static at 1.57 percent, the handout said.
Health authorities recorded the new cases after testing 16,434 samples in the last 24 hours.
With 1,056 recoveries in the past 24 hours, the country's recovery rate now stands at 92.46.
As of now, 7,33,866 people have recovered from the disease.
Eight of the 17 deaths recorded today are from Chattogram and five are from Dhaka divisions.
Also read: Bangladesh braces for worst Covid outbreak by June-end: Experts
One each died in Khulna, Barishal, Mymensingh and Sylhet divisions.
The country so far carried out 58,71,353 sample tests since reporting its first coronavirus cases on March 8 last year and the first death on March 18, 2020.
EU takes on AstraZeneca in court over vaccine deliveries
The European Union took on vaccine producer AstraZeneca in a Brussels court on Wednesday with the urgent demand that the company needs to make an immediate delivery of COVID-19 shots the bloc insists were already due.
AstraZeneca’s contract signed with the European Commission, the EU’s executive arm, on behalf of member states foresaw an initial 300 million doses for distribution among all 27 countries, with an option for a further 100 million. The doses were expected to be delivered throughout 2021. But only 30 million were sent during the first quarter.
Deliveries have increased slightly since then but, according to the European Commission, the company is set to provide only 70 million doses in the second quarter. It had promised 180 million.
EU lawyer Rafael Jafferali told the court that the company now expects to deliver the total number of doses by the end of December, but he added that “with a six-month delay, it’s obviously a failure.”
Read: Malawi destroys 20,000 expired doses of AstraZeneca vaccine
His main argument is that AstraZeneca should have used production sites in the bloc and the U.K. for EU supplies as part of a “best reasonable effort” clause in the contract. He said that 50 million doses that should have been delivered to the EU went to third countries instead, “in violation” of their contract.
Jafferali has said that the company should use all four plants listed in their contract for deliveries to the EU.
He also accused the company of misleading the European Commission by providing data lacking clarity on the delivery delays.
“The information provided by AstraZeneca did not allow us to fully understand the situation before mid-March 2021,” he said.
The EU has insisted its gripes with the company are about deliveries only and has repeatedly said that it has no problems with the safety or quality of the vaccine itself. The shots have been approved by the European Medicines Agency, the EU’s drug regulator.
While the bloc insists AstraZeneca has breached its contractual obligations, the company says it has fully complied with the agreement, arguing that vaccines are difficult to manufacture and it made its best effort to deliver on time.
Lawyers for the company will address the court later Wednesday.
As part of an advanced purchase agreement with vaccine companies, the EU said it invested 2.7 billion euros ($3.8 billion), including 336 million ($408 million), to finance the production of AstraZeneca’s serum at four factories.
The long-standing dispute drew media attention for weeks earlier this year amid a deadly surge of coronavirus infections in Europe, when delays in vaccine production and deliveries hampered the EU’s vaccination campaign.
Cheaper and easier to use than rival shots from Pfizer-BioNTech, the AstraZeneca vaccine developed with Oxford University was a pillar of the EU’s vaccine rollout. But the EU’s partnership with the firm quickly deteriorated amid accusations it favored its relationship with British authorities.
While the U.K. made quick progress in its vaccination campaign thanks to the AstraZeneca shots, the EU faced embarrassing complaints and criticism for its slow start.
Concerns over the pace of the rollout across the EU grew after AstraZeneca said it couldn’t supply EU members with as many doses as originally anticipated because of production capacity limits.
Read:Indonesia suspends AstraZeneca COVID-19 vaccine batch after death
The health situation has dramatically improved in Europe in recent weeks, with the number of COVID-19 hospitalizations and deaths on a sharp downward trend as vaccination has picked up. About 300 million doses of vaccine have been delivered in Europe — a region with around 450 million inhabitants, with about 245 million already administered.
About 46% of the EU population have had at least one dose.
In total, the European Commission has secured more than 2.5 billion of vaccine doses with various manufacturers. It recently sealed another major order with Pfizer and BioNTech through 2023 for an additional 1.8 billion doses of their COVID-19 shot to share between the bloc’s countries.
Following Wednesday’s hearing, a second one is slated for Friday, with a judgment to be delivered at a date to be announced. In addition to the emergency action, the European Commission has launched a claim on the merits of the case for damages for which a hearing hasn’t yet been set by the court.
South Korea mulls dropping masks for vaccinated
South Korean officials say they plan to allow people to drop their masks from July if they have received at least one dose of a coronavirus vaccine, as they mull incentives to promote inoculation.
Health Minister Kwon Deok-choel said Wednesday the plan is contingent on the government succeeding in its goal of administering first doses to 13 million people by the end of June. Officials say people will continue to be required to wear mask indoors or at outdoor gatherings where it’s difficult to maintain distance.
Read:Vaccine inequality in India sends many falling through gaps
Other incentives include providing vaccine-takers with discounts at public parks and museums and allowing them to participate in larger private gatherings. The country is currently clamping down on social gatherings of five or more people.
South Korea has wrestled with a slower vaccine rollout than many other developed economies.
Around 3.9 million people so far have received their first doses since the country launched its mass immunization program in late February, which represents less than 8% of the country’s 51 million population.
Health officials have lamented what they describe as excessive public fear of the AstraZeneca vaccine, which has been linked to rare blood-clotting side effects.
MORE ON THE VIRUS OUTBREAK:
— Vaccine inequality in India sends many falling through gaps
— Countries eager to reopen to travel as pandemic recedes
— UN official: Conflicts make controlling COVID more difficult
— A growing number of public schools in the U.S. are using mascots, food trucks and prize giveaways to encourage students to get vaccinated before summer vacation.
Read:Japan opens mass vaccination centers 2 months before Games
— The British government is facing accusations of reintroducing local lockdowns on the sly after it published new guidelines for eight areas of England that it says are hot spots for the coronavirus variant first identified in India.
Moderna says its COVID-19 shot works in kids as young as 12
Moderna said Tuesday its COVID-19 vaccine strongly protects kids as young as 12, a step that could put the shot on track to become the second option for that age group in the U.S.
With global vaccine supplies still tight, much of the world is struggling to vaccinate adults in the quest to end the pandemic. But earlier this month, the U.S. and Canada authorized another vaccine — the shot made by Pfizer and BioNTech — to be used starting at age 12.
Read: Local pharma seeks permission to bring Moderna vaccine: DGHS DG
Moderna aims to be next in line, saying it will submit its teen data to the U.S. Food and Drug Administration and other global regulators early next month.
The company studied more than 3,700 12- to 17-year-olds. Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects such as sore arms, headache and fatigue.
There were no COVID-19 diagnoses in those given two doses of the Moderna vaccine compared with four cases among kids given dummy shots. In a press release, the company also said the vaccine appeared 93% effective two weeks after the first dose.
While children are far less likely than adults to get seriously ill from COVID-19, they represent about 14% of the nation’s coronavirus cases. At least 316 have died in the U.S. alone, according to a tally by the American Academy of Pediatrics.
Read: EU commission greenlights Moderna’s COVID-19 vaccine
With plenty of vaccine supply in the U.S., younger teens flocked to get Pfizer’s shot in the days after FDA opened it to them, part of a push to get as many kids vaccinated as possible before the next school year.
Both Pfizer and Moderna have begun testing in even younger children, from age 11 down to 6-month-old babies. This testing is more complex: Teens receive the same dose as adults, but researchers are testing smaller doses in younger children. Experts hope to see some results in the fall.
Bangladesh begins administering 1st dose of Chinese vaccine
Bangladesh on Tuesday began administering the first dose of Chinese Sinopharm vaccine, marking a major turning point in its fight against Covid-19 pandemic.
Health Minister Zahid Maleque inaugurated the inoculation programme at Dhaka Medical College and Hospital.
On May 12, Bangladesh received 5 lakh China’s Sinopharm Covid-19 vaccine doses, donated by the Chinese government.
Since the outbreak of the pandemic last year, China and Bangladesh have been supporting and assisting each other in their fight against the pandemic.
China has donated and is donating vaccine doses to 80 developing countries with urgent needs, and has provided support under COVAX for the emergency use of vaccines in developing countries.
Also read: Process to procure vaccine from China at final stage: FM
China has fulfilled its commitment to make the Covid-19 vaccine a global public good with practical actions, promoted the fair distribution of global vaccines and made China’s contribution to the realisation of vaccine accessibility and affordability in developing countries.
China says it will continue to make joint efforts with Bangladesh to make positive contributions to Bangladesh’s endeavour of protecting human lives and fight to win the battle against the pandemic, and together to build an even closer community of shared future and health for mankind.
Covid-19 vaccines: Commonwealth health ministers demand equal access for everyone
Commonwealth health ministers have called for swift and equal access to Covid-19 vaccines for everyone around the world.
They expressed deep concern over the stark gaps in access and delivery of doses, especially in poor countries, and called for "fair and transparent" pricing for the vaccine in a joint statement Friday on behalf of the 54 Commonwealth member countries.
Only 0.3% of the life-saving vaccine doses have been administered in 29 poor countries. About 84% of shots have been given in high and upper-middle-income countries.
Commonwealth Secretary-General Patricia Scotland said: "The science is clear: vaccination works and is the clear and only sustainable route out of this pandemic for the whole world."
"The rise of new variants shows that until everyone is safe no one is safe. No plan to tackle this virus will work until everyone agrees to work together."
"We must talk with each other to move away from some stockpiling vaccines, while many low-middle income countries still do not have access to the much-needed vaccine supplies for the vulnerable populations in their countries. So, cooperation to develop a global immunisation plan to deliver equal access to vaccines must be a top priority," Patricia added.
Vaccine equity
The Commonwealth health ministers appreciated the global vaccine equity initiative "COVAX" and encouraged all partners to support government efforts on boosting vaccine confidence and immunisation drives.
Recognising the acute gaps in research and development of new tests, vaccines and therapies in the Commonwealth, they stressed enhanced collaboration with scientists, academics and business leaders.
Speaking at the meeting, the World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said: "Vaccines are reducing severe disease and death in countries that are fortunate enough to have them in sufficient quantities, and early results suggest that vaccines might also drive down transmission."
"The shocking global disparity in access to vaccines remains one of the biggest risks to ending the pandemic. We seek the support of the Commonwealth in solving the global vaccine crisis by funding the ACT Accelerator, advocating for greater sharing of technology, know-how and intellectual property, and sharing doses with COVAX."
The ministers further backed a potential treaty on the fight against pandemics and a Commonwealth mechanism to share and distribute extra medical supplies such as ventilators and medicines.
They called on the heads of government to allocate resources for strengthening health systems, especially through primary healthcare, towards attaining universal health coverage.
Maintaining essential health services
New data shows 60 immunisation campaigns for other health threats are now suspended in 50 countries due to Covid-19. Such delays could cause significant avoidable mortality.
Disruptions to HIV/AIDS services, for instance, could lead to five thousand excess deaths globally.
So, the ministers committed to keeping essential health services running and sustaining the gains made towards tackling threats such as malaria, HIV/AIDS, avoidable blindness and non-communicable diseases while dealing with an influx of Covid-19 cases.
In their statement, they further voiced their support for a common framework for sovereign debt treatments, cooperation with the WHO and improved compliance with the International Health Regulations for preventing the spread of disease.
This is the second time that Commonwealth health ministers met virtually for their annual gathering due to the Covid-19 pandemic.
The meeting, hosted by the Commonwealth Secretariat, took place on 20 and 21 May.
Covid vaccine: China to send additional 6 lakh doses as gift
China is preparing a the second batch of 600,000 doses of its COVID-19 vaccine to Bangladesh.
The announcement came Friday, just nine days after the arrival of the first batch of 500,000 doses of Sinopharm vaccine as a gift.
China says the move fully reflects that it attaches great importance to the friendly relations between the two countries.
Chinese State Councilor and Foreign Minister Wang Yi had a phone conversation with Foreign Minister Dr AK Abdul Momen on Friday to this end.
Read Bangladesh, China, others call for avoiding vaccine nationalism
At the request of Bangladesh, it was announced that China would handover the second batch of 600,0000 vaccine doses to Bangladesh.
China pays close attention to the latest situation of the epidemic in Bangladesh, the Chinese Embassy in Dhaka said.
At this critical time in Bangladesh’s fight against the epidemic, China is concerned about the urgent need for vaccinating its Bangladeshi friends, to help the overcomes the huge demand for domestic and foreign orders and the shortage of vaccine supply, it said.
The arrival of the second batch vaccine will definitely help the Bangladeshi government and people build a strong line of defense against the epidemic, China said.
Also read: Govt approves proposal to import Sinofarm vaccine
In the future, China is willing to provide necessary support for Bangladesh and South Asian countries to fight the epidemic, deepen anti-epidemic cooperation with Bangladesh, and effectively protect the health and security of their citizens.
The Chinese Foreign Minister assured of providing all kinds of support to ensure continuation of "stable supply" of COVID vaccines to Bangladesh.
Dr Momen requested his Chinese counterpart to take an initiative for coproduction of vaccines in Bangladesh.
The Chinese Foreign Minister said they will encourage the Chinese companies to go for coproduction of vaccines with Bangladesh.
Read WHO team working with Chinese vaccine producers ahead of potential emergency use: WHO director-general
He said China keeps up its support with Malaysia, Turkey, Brazil and the United Arab Emirates on vaccine coproduction.
Malawi destroys 20,000 expired doses of AstraZeneca vaccine
Malawi has burned nearly 20,000 expired AstraZeneca vaccines, amid conflicting advice over what to do with the doses.
Health Minister Khumbize Kandodo Chiponda put some of the vials of the expired doses into an incinerator to start the destruction Wednesday at Kamuzu Central Hospital in Lilongwe, the capital.
“We are destroying (these vaccines) because as government policy no expired health commodities are to be used,” she said. “Historically under the expanded immunization program of Malawi no expired vaccine has ever been used.”
She said burning the vaccines will build public confidence that all vaccines used in Malawi are good.
Read: US going to be largest sharer of vaccines with 80mn additional doses: Official
“We are destroying publicly in order to stay accountable to Malawians. The vaccines that expired are not being used during the vaccination campaign,” she said. “On behalf of the government, I assure all Malawians that no one will be given an expired COVID vaccine.”
The burned vaccines were the remainder of 102,000 doses that arrived in Malawi on March 26 with just 18 days until they expired on April 13. All other doses of the shipment, donated by the African Union, were successfully administered, she said.
The health minister thanked WHO, the African Union and India for donating the vaccines.
“This has made it possible for Malawi to embark on the COVID vaccination campaign currently underway,” she said.
Last month the World Health Organization urged African nations not to destroy expired doses of the AstraZeneca vaccine after several countries received doses from India with a very short shelf life. But this week, WHO reversed its position and said that the vaccines should be destroyed.
“Any vaccine that has passed its expiry date ... should not be administered,” said WHO in a statement dated May 17. “While discarding vaccines is deeply regrettable in the context of any immunization program, WHO recommends that these expired doses should be removed from the distribution chain and safely disposed.”
Read: India to begin clinical trials for Covd-19 vaccine in children
WHO said that in March, the African Union’s African Vaccine Acquisition Task Team redistributed 925,000 doses of the AstraZeneca vaccine produced by the Serum Institute of India with an expiry date of April 13 to 13 African countries. “The bulk of these vaccine doses were administered, but some countries have unused doses remaining,” said the WHO statement.
Malawi, a small southern African country of about 20 million people, had already decided to destroy its expired vaccine doses, ministry of health spokesman Joshua Malango told The Associated Press.
“We had stopped observation of proper storage mechanisms and the vaccines would have still been damaged in one way or the other,” he said.
The destruction of the vaccines was witnessed by several top officials “in order to enhance transparency,” health secretary Charles Mwansambo said.
Malawi will still have adequate stocks of COVID-19 vaccines in both public and private health facilities, he said. The government has not said where it will get more vaccines.
Malawi’s got its first consignment of 360,000 AstraZeneca doses in early March from the U.N.-backed COVAX initiative which is providing vaccines to low- and middle-income countries. The country received another batch of 50,000 AstraZeneca doses from the Indian government. With the AU donation, Malawi had a total of 512,000 AstraZeneca doses.
So far 212,615 doses have been given in Malawi. The country has 34,216 confirmed cases, including 1,153 deaths, according to the Africa CDC.
Read:Biden boosting world vaccine sharing commitment to 80M doses
Currently, the country is seeing a decrease in the disease, with the 7-day rolling average of daily new cases in Malawi dropping from 0.07 new cases per 100,000 people on May 4 to 0.04 new cases per 100,000 people on May 18. Official deaths from COVID-19 are also declining, according to statistics from Johns Hopkins University.
Malawi, like many other African countries, has relied on the AstraZeneca vaccine that has been distributed by COVAX and the African Union. But now supplies of the vaccine have become more scarce because India, the main supplier of vaccines to COVAX, has stopped exports until it has adequately vaccinated large numbers of its population of 1.4 billion people.
The Serum Institute of India says it hopes to start delivering coronavirus vaccines to COVAX and to other countries by the end of the year. The delay will significantly set back global efforts to immunize people against COVID-19. India’s Serum Institute is the world’s biggest vaccine-maker. The company said in March that it was postponing all exports of coronavirus vaccines to deal with the explosive surge of cases on the subcontinent. At the time, the World Health Organization said it expected COVID-19 vaccine deliveries from India to resume by June and the interruption would affect about 90 million doses.