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Corona Virus Vaccines

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I have been saying this for a while, they need to give all that stuff away, as soon as possible


U.S. to share 60 million doses of AstraZeneca Covid vaccine with other countries​

White House Covid adviser Andy Slavitt said in a tweet Monday that doses would be sent to other countries “as soon as they become available.”

WASHINGTON — The United States plans to ship its stockpile of millions of AstraZeneca vaccine doses overseas, a move aimed at helping other countries struggling with a lack of doses to vaccinate their populations.

White House Covid-19 adviser Andy Slavitt said in a tweet Monday that 60 million doses of the vaccine would be sent to other countries “as soon as they become available.”


The decision comes as the pandemic has spiked in India, where thousands are dying daily as the nation’s stressed hospitals struggle to treat the virus. President Joe Biden spoke to India's Prime Minister Narendra Modi Monday and administration officials said Monday they are sending a range of supplies to India, including oxygen equipment, raw materials used in vaccine production, rapid testing kits, and the treatment Remdesivir.

Public health officials, lawmakers and world leaders have been urging the U.S. to release some of its stockpile of the AstraZeneca vaccine to other countries that have cleared it for use while American reviews of safety and efficacy data continue. Slavitt didn't mention names of countries to which the vaccine doses would be sent.

White House press secretary Jen Psaki said no doses will be shared until the Food and Drug Administration has concluded its review, which should take several more weeks. She said the U.S. currently has 10 million doses and expects an additional 50 million to be delivered by the company during May and June.

"Given that AstraZeneca is not authorized for use in the United States, we do not need to use AstraZeneca in our fight against Covid over the next few months," she said. "Before any AstraZeneca doses are shipped from the United States, the FDA will confirm any such doses meet its expectation for product quality.”

The AstraZeneca vaccine has suffered from delays after "very rare" incidents of blood clots and questions over the data the company submitted to the FDA.

The Biden administration had said it would wait to share significant numbers of its doses with other countries until it had ensured enough supply for Americans. But in recent days, administration officials have said they are confident they will have enough doses of the Pfizer and the Modern vaccines to vaccinate every U.S. adult who wants one. The two companies have agreed to supply a total of 600 million doses by the end of July.

An administration official told reporters said they are confident the U.S. will have enough supply from the three other available vaccines to meet the needs of Americans for the next several months.

Use of the Johnson & Johnson vaccine restarted this week after a pause to study a rare side effect of blood clots.

At the same time, the U.S. rate of vaccinations has declined over the past week and administration officials have said supply currently outstrips the demand.


The U.S. has already committed to sharing 4 million doses of the AstraZeneca vaccine with Canada and Mexico.

Rep. Raja Krishnamoorthi, D-Ill., who sits on the House Select Subcommittee on the Coronavirus Crisis, and other lawmakers have been urging the U.S. to share its stockpile of doses with India.

“We cannot allow these vaccine doses to go unused, we should send them abroad where they can be used and they can save lives, right now,” he said on MSNBC.

India’s coronavirus infections have set a new world record in recent days with more than 350,000 new infections within 24 hours. Hospitals have said they are overwhelmed and begging for oxygen supplies as a humanitarian crisis unfolds in the world’s second most populous country.
 

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Rep. Raja Krishnamoorthi, D-Ill., who sits on the House Select Subcommittee on the Coronavirus Crisis, and other lawmakers have been urging the U.S. to share its stockpile of doses with India.

Don't India have it's own vaccine? or it was just a fabricated news as usual!
 

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Israel Examines Heart Inflammation Cases After Pfizer Shot

April 26, 2021


Israel is examining dozens of cases where people experienced heart inflammation after receiving Pfizer Inc. and BioNTech SE’s coronavirus vaccine.

Health officials are investigating whether the cases are connected with the shot which has been administered to more than 5 million people, Corona Commissioner Nachman Ash said Sunday in an interview with Radio 103FM. The government identified 62 incidents of inflammation of the heart muscle, or heart-muscle membrane, Channel 12 reported last week, citing a health ministry study.

The condition developed in one out of 100,000 people who received the shot, while the incidence rate for men of 18 to 30 years was one in 20,000. Two people died and the rest recovered.

The study doesn’t show with certainty that there’s a higher rate in mortality or an increase in heart muscle inflammation cases, the Health Ministry said in an emailed response to questions.

“It looks like the benefit of the vaccine is so great that even if we do find a connection between some of the cases and the vaccine, it won’t be justified to take any action regarding the vaccine,” Ash said in the interview. The information has been communicated with Pfizer, he said.

Pfizer is aware of the Israeli cases of myocarditis, the company said in a statement.

“We have not observed a higher rate of myocarditis than what would be expected in the general population,” it said. “A causal link to the vaccine has not been established. There is no evidence at this time to conclude that myocarditis is a risk associated” with the use of the Pfizer-BioNTech’s vaccine, the company said.
 

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The dark horse of the Covid-19 vaccine race may be this French biotech firm

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    5 hours ago
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The first participant in Valneva's phase three trials will be dosed this week. PHOTO: AFP

PARIS (BLOOMBERG) - As the battle with Covid-19 rages around the world, a small French biotech firm has a possible solution for the long-term war against the virus and the rapidly spreading mutations.

The company, Valneva SE, has a vaccine that could be more variant-proof, giving it an edge over other shots in what may be an annual campaign against a disease that has already killed more than three million people.

The first participant in its phase three trials will be dosed this week. If successful, that could lead to an approved shot this autumn.

Valneva's shot is the only candidate in clinical trials in Europe that uses a tried-and-true vaccine technology involving an inactivated version of the whole virus it is targeting.

Inactivated vaccines - a century-old approach adopted for flu and polio - take a sample of the disease that has been killed and use it to stimulate an immune response without creating infection.

With all the other Covid-19 vaccines in the region focused on the virus' spike protein, the shot could protect against variants that might compromise others, making it the perfect booster.

The company already has a deal with the UK to supply up to 190 million doses.

Ms Kate Bingham, former head of the UK's Vaccine Taskforce, says that if the shot is successful, it will probably be used as a winter booster for older adults.
"Having that broader antigenic real estate from a whole virus vaccine really matters," she said.
"Viruses mutate. So, by having a broader immune response, which you get with a whole vaccine, you can potentially provide that ongoing protection."

The healthcare implications in a post-Covid world are huge. And for Valneva, with a US$100 million (S$133 million) listing planned on Nasdaq this year, the financial stakes are high.

The UK contract is worth up to €1.4 billion (S$2.25 billion), more than 10 times its annual revenues last year.

The company said on Thursday that it will sell about 7.1 million shares in the offering, and use the proceeds to fund the Covid-19 vaccine, as well as the development of other products in its pipeline.

The path to success is not straightforward, though.

Due to the more onerous development involved with an inactivated approach, the Valneva vaccine was always going to be later into the clinic than other shots, which means its advanced trials are starting in Britain, when more than half the country has already been vaccinated.

As a result, the vaccine is being tested head to head with a shot from AstraZeneca and the University of Oxford, rather than a dummy placebo, and must show an equal or superior antibody response.

"There is no development without risk," said chief executive Thomas Lingelbach, who does not know how the chance of regulatory approval would be affected if the shot was even slightly less effective than the AstraZeneca vaccine.

"To be honest with you, I don't even like to think about that scenario."

It is not the first time that the 57-year-old has taken a risk.

In summer 2012, when he was CEO of Austrian biotech Intercell AG, Mr Lingelbach met Mr Franck Grimaud, the CEO of French company Vivalis, at one of Vienna's oldest restaurants.

Both businesses were struggling, and a London banker had suggested the pair get together to discuss a possible tie-up.

By the end of their meal at Ofenloch, they decided that together, they could become a key specialist vaccine company focused on developing inoculations for diseases with limited preventive or therapeutic treatment options.

"In one evening, we put everything on the table, where we are strong, where we are weak, and why it would make sense to join," said Mr Grimaud, who is now Valneva's president and chief business officer.

"We did what we said during this meeting."

When the pandemic hit last year, the company had two approved travel vaccines in its portfolio, one for Japanese encephalitis and another for cholera.

Two more, against Lyme disease and chikungunya, a virus contracted from mosquitoes, were in the clinical phase.

More on this topic

Valneva to start clinical trials of Covid-19 vaccine candidate in UK

UK invests $25 million in Scottish Covid-19 vaccine site

As soon as it became clear Covid-19 was not going away quickly, the Valneva executives saw an opportunity to capitalise on the company's experience.

With Pfizer, Moderna and Oxford pursuing messenger RNA and adenovirus vaccines, there was a gap for an inactivated approach.

In April 2020, as much of Europe went into lockdown and infections climbed rapidly, the company started work on a shot using its Japanese encephalitis platform.

The idea was it would be "complementary to the other vaccines, either in terms of sub-population - immunosuppressed, pregnant women, children or, and we see it more and more emerging, the fact that inactivated vaccines could make sense as a booster," said Mr Grimaud, 55.

The UK quickly signed up to buy the shot and invested in a Valneva manufacturing site in Scotland.

Human trials started last December and reported positive data this month - producing significant levels of antibodies in more than 90 per cent of participants and raising no safety concerns.

Another potential deal with the European Commission, in the works since the third quarter of 2020, ended this month.
The company is now focusing on bilateral deals with individual EU countries.

Mr Lingelbach will not go into details, but alludes to problems European officials had with the UK getting priority treatment - a factor baked into the British deal from the start.

A spokesman for the European Commission said it is aware of Valneva's position and is in discussion with member states on how to proceed.
The company did not meet certain conditions for a deal, he said.

"Despite a lot of effort, we have not made progress," Mr Lingelbach said. "It has gone in circles, and circles and circles."

The company has also had discussions with Australia and Canada about possible orders.

Other inactivated Covid-19 vaccines exist beyond Europe. China's Sinovac Biotech and Sinopharm have also used the approach.

While the Sinovac vaccine initially posted an efficacy figure of about 50 per cent - lower than other vaccines and around the minimum regulatory threshold needed - more real-world data suggests the number could be higher.

Sinopharm's inactivated shots have both reported efficacy above 70 per cent.

In an ideal world, the Valneva vaccine would be tested against another inactivated shot, said Mr Lingelbach, but because there is no approved one in the West, the AstraZeneca vaccine was the next best comparison.

Adjustments have had to be made to take account of different dosing schedules and the age restriction on the AstraZeneca shot in the UK.

Alongside the possibility that the Covid-19 vaccine could be a regular booster shot providing sustainable revenue, the company is also hoping its Lyme and chikungunya vaccines will both be in use by 2025, moving the company into a different league.

Valneva has added hundreds of staff and plans to go from output of about three million vaccines a year to more than 100 million next year if the Covid-19 shot is successful.
"It's not the same game," said Mr Grimaud.

It is "what makes us wake up every morning, but sometimes not sleep at night as well".
 

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Israel Examines Heart Inflammation Cases After Pfizer Shot

April 26, 2021


Israel is examining dozens of cases where people experienced heart inflammation after receiving Pfizer Inc. and BioNTech SE’s coronavirus vaccine.

Health officials are investigating whether the cases are connected with the shot which has been administered to more than 5 million people, Corona Commissioner Nachman Ash said Sunday in an interview with Radio 103FM. The government identified 62 incidents of inflammation of the heart muscle, or heart-muscle membrane, Channel 12 reported last week, citing a health ministry study.

The condition developed in one out of 100,000 people who received the shot, while the incidence rate for men of 18 to 30 years was one in 20,000. Two people died and the rest recovered.

The study doesn’t show with certainty that there’s a higher rate in mortality or an increase in heart muscle inflammation cases, the Health Ministry said in an emailed response to questions.

“It looks like the benefit of the vaccine is so great that even if we do find a connection between some of the cases and the vaccine, it won’t be justified to take any action regarding the vaccine,” Ash said in the interview. The information has been communicated with Pfizer, he said.

Pfizer is aware of the Israeli cases of myocarditis, the company said in a statement.

“We have not observed a higher rate of myocarditis than what would be expected in the general population,” it said. “A causal link to the vaccine has not been established. There is no evidence at this time to conclude that myocarditis is a risk associated” with the use of the Pfizer-BioNTech’s vaccine, the company said.
The Army has had some cases too they are looking into, a medical professional that I know told me they have 2 with liver inflammation after vaccination, but I would say that it is probably better to get the shot, because numbers of people having problems, and there will always be some small fraction of people that have certain side effects.
 

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NYC Pitches Free Vaccines for Tourists in Bid to Expedite Post-Pandemic Recovery​

Broadway shows just started selling tickets for a 100% fall reopening of the stage -- but how many theaters will fill?​

  • Broadway will fully reopen its doors this September, Gov. Andrew Cuomo said Wednesday; that could bring back more tourists -- and the city wants to offer free vaccinations to those who visit
  • At this point, masks, health screenings, enhanced air filtration and ventilation as well as rigorous cleaning and disinfection requirements will be mandatory, Cuomo said; that remains subject to change
  • Large-scale outdoor venue capacity will increase May 19 with new fully vaccinated fan sections; and if you get vaccinated on-site at Citi Field or Yankee Stadium, you get a free ticket to an upcoming game
New York City wants to roll out mobile vaccination sites for visiting tourists as the five boroughs look to revive their vibrancy post-pandemic, Mayor Bill de Blasio says.

De Blasio described the program, which would target tourists with free Johnson & Johnson doses at popular attractions, leaving them fully vaccinated (though not yet immune) to enjoy their stay in the city and reap the benefit of convenience.

The mayor says the state needs to modify the rules around vaccination a bit to approve the administering of shots to non-New Yorkers who don't work here, but he said his team was working with Gov. Andrew Cuomo's administration to get it done.

De Blasio says the mobile vans are ready to roll out as early as this weekend at spots ranging from the Empire State Building and Times Square to Brooklyn Bridge Park, the High Line and Central Park, among others, pending the state's green light.

"This is a positive message to tourists. Come here, it's safe, it's a great safe to be and we're gonna take care of you," de Blasio said. "We're going to make sure you get vaccinated while you're here with us."
 

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From NYT's bullet points

THE LATEST NEWS​

The Virus
  • The Tokyo Olympics will offer the Pfizer vaccine to athletes and officials. Japan has declined to use a Chinese-made vaccine, which studies have shown to be less effective.
  • Companies are wavering on requiring employees to get vaccinated. It’s a delicate balance between health and privacy.
  • Contamination at a Baltimore vaccine manufacturer is slowing the pace of shots in Canada, Europe and South Africa.
  • In a sign of flagging demand, only 9 percent of American adults have not been vaccinated and say they would like to get a shot as soon as possible, a poll showed.
  • Virus resources: More than 240,000 cases have been linked to U.S. colleges in 2021. See your school’s numbers.
 

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Sinopharm: Chinese Covid vaccine gets WHO emergency approval

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The World Health Organization (WHO) has granted emergency approval for the Covid vaccine made by Chinese state-owned company Sinopharm.

It is the first vaccine developed by a non-Western country to get WHO backing.

The vaccine has already been given to millions of people in China and elsewhere.

The WHO had previously only approved the vaccines made by Pfizer, AstraZeneca, Johnson & Johnson and Moderna.

But individual health regulators in various countries - especially poorer ones in Africa, Latin America and Asia - have approved Chinese jabs for emergency use.

With little data released internationally early on, the effectiveness of the various Chinese vaccines has long been uncertain.

But the WHO on Friday said it had validated the "safety, efficacy and quality" of the Sinopharm jab.

The WHO said the addition of the vaccine had "the potential to rapidly accelerate Covid-19 vaccine access for countries seeking to protect health workers and populations at risk".

It is recommending that the vaccine be administered in two doses to those aged 18 and over.

A decision is expected in the coming days on another Chinese vaccine developed by Sinovac, while Russia's Sputnik vaccine is under assessment.

Why does WHO backing matter?

The green light from the global health body is a guideline for national regulators that a vaccine is safe and effective.
WHO director-general Tedros Adhanom Ghebreyesus said it would give countries "confidence to expedite their own regulatory approval".

It also means that the vaccine can be used in the global Covax programme, which was set up last year to try to ensure fair access to vaccines among rich and poor nations.

The decision to list the Chinese vaccine for emergency use is expected to give a substantial boost to the scheme, which has been struggling with supply problems.
Prior to the WHO approval, the Sinopharm vaccine was already being widely used, with an estimated 65 million doses administered, according to reports.

In addition to China, countries already using the vaccine include the UAE, Pakistan and Hungary.

The decision on Friday to approve the vaccine for emergency use was made by the WHO's technical advisory group, which reviewed the latest clinical data and manufacturing practices.

It said the vaccine's efficacy for symptomatic and hospitalised cases of Covid-19 was estimated to be 79%.

The WHO noted that few adults over the age of 60 were included in clinical trials, so efficacy could not be estimated for this age group. But it said there was no reason to think that the vaccine would act differently in older recipients.

The health body is yet to reach a decision on China's Sinovac vaccine. WHO experts on Friday said they were awaiting additional information before they could make a recommendation.

Millions of doses of that vaccine have also already been shipped to a number of countries, which have permitted its emergency usage

One of the Chinese vaccines' main advantages is that they can be stored in a standard refrigerator at 2-8 degrees Celsius, like the AstraZeneca vaccine.

The WHO said these "easy storage requirements" made the Sinopharm vaccine "highly suitable for low-resource settings".

How do the Chinese shots work?

The two Chinese vaccines differ significantly from some of the other Covid vaccines currently in use, especially those by Pfizer and Moderna.

Developed in a more traditional way, they are so-called inactivated vaccines, which means they use killed viral particles to expose the immune system to the virus without risking a serious disease response.
Graphic


By comparison, the BioNtech/Pfizer and Moderna vaccines are mRNA vaccines. This means part of the coronavirus' genetic code is injected into the body, training the immune system how to respond to it.

The UK's AstraZeneca vaccine is yet another type of vaccine where a version of a common cold virus from chimpanzees is modified to contain genetic material shared by the coronavirus. Once injected, it teaches the immune system how to fight the real virus.

BioNTech/Pfizer and Moderna have an efficacy rate of around 90% or higher, while the AstraZeneca jab is thought to be around 76%.

In April, China's top disease control official said the efficacy of the country's Covid vaccines was low, although he later insisted his comments had been misinterpreted.
 

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Hayat-Vax: Made-in-UAE Covid vaccine distribution begins

Last updated on May 10, 2021 at 11.43 pm
1620732549400.png

Hayat is the first indigenous Covid-19 vaccine in the region to be manufactured by a joint venture between Abu Dhabi’s G42 and Sinopharm.


The UAE has started distributing its locally-made Covid-19 vaccine called 'Hayat-Vax', authorities announced on Monday.

Hayat - which means 'life' in Arabic - is the first indigenous Covid-19 vaccine in the region to be manufactured by a joint venture between Abu Dhabi's G42 and Sinopharm.

It is the same Sinopharm vaccine that was registered by the UAE Ministry of Health and Prevention in December last year.
Authorities in the UAE said that the vaccine is getting approvals in other countries.
Health Sector: We are pleased to announce the start of production of the "Hayat-Vax" vaccine in the #UAE, marking the start of a historic stage for vaccine manufacturing in the country.#TogetherWeRecover pic.twitter.com/2kkmbbiAEk
- NCEMA UAE (@NCEMAUAE) May 10, 2021

China's Sinopharm vaccine received approval from the World Health Organisation last week. Officials said the UAE contributed in "providing all vaccine data to support this decision".

The UAE had in July 2020 launched the world's first phase III clinical trial of the Covid-19 inactivated vaccine.

"The UAE has been proactive in using the Sinopharm vaccine ... After conducting assessments at the local level, the vaccine proved to be effective and safe. Moreover, it has important features such as easy transportation and storage," the National Emergency Crisis and Disaster Management Authority (NCEMA) said.

A health sector spokesperson explained that the Sinopharm vaccine was conventionally manufactured based on an inactive virus. "So, this gives a greater safety and efficacy percentage to protect against dangerous complications.

"The vaccine has also proven to be effective in many countries worldwide that have participated in its clinical trials at various stages."

The official also said that more than 72.03 per cent of the total eligible population have got the vaccine. Close to 80 per cent of the elderly (60 years and above) have received the jab.

In all, the UAE has administered 11.18 million Covid vaccine doses, with a rate of 113.10 doses per 100 people.

The official also cited a local study that found a significant decrease in the rate of Covid-19 infections among fully vaccinated residents. "The effectiveness of vaccination in preventing people from having to go to hospital is 93 per cent, while in reducing the need for intensive care, it is 95 per cent."
 

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FDA authorizes Pfizer coronavirus vaccine for adolescents 12 to 15 years old​

The Food and Drug Administration cleared the first coronavirusvaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.

The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.

“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”

Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.
In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.

Children rarely suffer serious bouts of covid-19, the illness caused by the coronavirus. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total. But that exceeds the number of children who die in a bad flu season.

I will stop here because it's really long, if you would like to read the whole thing follow the link.
 

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First U.S. Vaccine Donations Will Go to ‘Wide Range’ of Nations in Need​

Latin America, South and Southeast Asia and Africa will be among the recipients of an initial 25 million excess doses that the Biden administration is sharing this month.
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People receiving Pfizer’s Covid-19 vaccine last month in San Miguelito, Panama. Most of the Biden administration’s first overseas vaccine shipment will be given to the international vaccine effort known as Covax.Credit...Bienvenido Velasco/EPA, via Shutterstock

Sheryl Gay Stolberg
By Sheryl Gay Stolberg
June 3, 2021
WASHINGTON — The White House, besieged with requests from other nations to share its supply of coronavirus vaccine, announced Thursday that it would distribute an initial 25 million doses this month across a “wide range of countries” in Latin America and the Caribbean, South and Southeast Asia, and Africa, as well as the Palestinian territories, war-ravaged Gaza and the West Bank.

The doses are the first of a total 80 million that President Biden has pledged to send overseas by the end of this month. Three-quarters of the initial batch will be given to the international vaccine effort known as Covax, officials said at a White House briefing on the pandemic, though administration officials are helping decide where to send them.

The rest will be reserved for “immediate needs and to help with surges around the world” and regions dealing with “urgent, present crises,” said Jake Sullivan, the president’s national security adviser, including in India, Ukraine and Iraq as well as the West Bank and Gaza.

But the donation is nowhere close to enough. About 11 billion doses are needed to vaccinate 70 percent of the world’s population against the coronavirus, according to estimates from researchers at Duke University. As of last month, the analytics firm Airfinity estimated that 1.7 billion doses had been produced.

Thursday’s announcement comes a week before Mr. Biden leaves for Cornwall, England, to meet with the heads of state of the Group of 7 industrialized nations, where the global vaccine supply is certain to be a topic of discussion. Officials said the Biden administration would donate additional doses throughout the summer as they become available.

“This is just the beginning,” said Jeffrey Zients, Mr. Biden’s coronavirus response coordinator. “Expect a regular cadence of shipments around the world, across the next several weeks.”

While China and Russia have used vaccine donations as an instrument of diplomacy in an effort to extract favors from other nations, Mr. Biden has insisted the United States will not do that — a point that Mr. Sullivan emphasized on Thursday in describing the White House strategy.

Nearly two-thirds of U.S. adults have had at least one shot of a coronavirus vaccine, and the rate of new cases and deaths has plummeted, contributing to an overall picture across the country that is “encouraging and uplifting,” Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, said on Thursday.

But the picture around the world, especially in poorer nations in Africa and Central and South America, where vaccination rates are much lower, is bleak. According to data from Johns Hopkins University, Uruguay, Argentina, Colombia and Paraguay are all awash in new cases; in Colombia, nearly 500 people a day have died of the coronavirus over the past several weeks. A sudden, sharp rise in coronavirus cases in many parts of Africa could amount to a continental third wave, the World Health Organization warned on Thursday.

Some African nations have less than 1 percent of their populations partly vaccinated, according to data from the Our World in Dataproject at the University of Oxford, and the percentages of vaccinated people in Honduras and Guatemala are around 3 percent of the population.

Mr. Sullivan said the administration had decided to give priority to “neighbors” of the United States, including countries like Guatemala and Colombia, Peru and Ecuador, while also working with existing regional networks like the African Union to allow local authorities to allocate the vaccines as they see fit.

Mr. Biden came into office vowing to restore America’s position as a leader in global health, and he has been under increasing pressure from activists, as well as some business leaders, to do more to address the global vaccine shortage. This year, he said he was reluctant to give away vaccine doses until the United States had enough for its own population, though he promised in March to send a total of four million doses of AstraZeneca’s vaccine to Mexico and Canada.

Those doses, it turned out, were made at a Baltimore facility owned by Emergent BioSolutions, where production has since been put on hold after an incident of contamination.

Mr. Biden’s pledge to donate 80 million doses this month involves vaccines made by four manufacturers. Besides AstraZeneca, they are Pfizer-BioNTech, Moderna and Johnson & Johnson, the last three of which have received U.S. emergency authorization for their vaccines.

The president has made several announcements to help reach his goal. He said last month that his administration would send 20 million doses of the authorized vaccines overseas in June — the first time he had pledged to give away doses that could be used in the United States. Officials said Thursday that the number rose to 25 million because more authorized doses have become available.

Mr. Biden also announced last month that he would send one million doses of Johnson & Johnson’s vaccine to South Korea; a plane carrying those doses was expected to take off Thursday evening, Mr. Zients said.

And the president has pledged to donate up to 60 million doses of AstraZeneca’s vaccine. But those doses, also made at the Emergent plant, are not authorized for domestic use and cannot be released to other countries until regulators deem them safe. If they are not cleared for release, Mr. Biden would have to agree to donate more of the three vaccines used here to fulfill his 80 million promise.

The president has described the vaccine donations as part of an “entirely new effort” to increase vaccine supplies and vastly expand manufacturing capacity, most of it in the United States. To further broaden supply, Mr. Biden recently announced he would support waiving intellectual property protections for coronavirus vaccines. He also put Mr. Zients in charge of developing a global vaccine strategy.

But activists say simply donating excess doses and supporting the waiver are not enough. They argue that Mr. Biden must create the conditions for pharmaceutical companies to transfer their intellectual property to vaccine makers overseas, so that other countries can establish their own vaccine manufacturing operations.

Peter Maybarduk, the director of Public Citizen’s Access to Medicines program, called Thursday for the administration to invest $25 billion in “urgent public vaccine manufacturing at sites worldwide” to make eight billion doses of vaccine using mRNA technology within a year, and to “share those vaccine recipes with the world.”

Asked recently whether the United States was prepared to do that, Andrew Slavitt, a senior health adviser to the president, sidestepped the question, saying only that the United States would “play a leadership role” but still needed “global partners across the world.”

On Thursday, Mr. Zients said the United States was lifting the Defense Production Act’s “priority rating” for three vaccine makers — AstraZeneca, Novavax and Sanofi — that do not make coronavirus vaccines authorized for U.S. use. The shift means that companies in the United States that supply the vaccine makers will be able to “make their own decisions on which orders to fulfill first,” Mr. Zients said.

That could free up supplies for foreign vaccine makers, allowing other countries to ramp up their own programs.

Abdi Latif Dahir contributed reporting.
 

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DoD Confirms: Rare Heart Inflammation Cases Linked to COVID-19 Vaccines


30 Jun 2021

A new study of U.S. service members found higher than expected rates of heart inflammation following receipt of COVID-19 vaccines. It's a finding Defense Department researchers say should call attention to the condition, known as myocarditis, as a potential side effect of the immunizations.

In an article published Tuesday in JAMA Cardiology, U.S. Army, Navy and Air Force physicians described 23 cases of myocarditis in previously healthy males who developed the condition within four days of receiving a COVID-19 vaccine.

Physicians would have expected to find eight or fewer cases of myocarditis among the 436,000 male military members who received two mRNA shots, according to the study. But 20 military members developed inflammation after their second dose, including 14 after the Moderna shot and six after the Pfizer shot. Three developed the condition after their first vaccine.

All were previously healthy and physically fit and none showed any evidence of having acute COVID-19 illness or any other infection, according to the report.

Personnel in the study ranged in age from 20 to 51. Cardiac symptoms resolved within a week of onset for 16 patients, but seven continued to have chest pain at the time of publication.

An association between the COVID-19 vaccines and myocarditis was first reported in Israel with a case study in February involving a 19-year-old male. The U.S. military was the first to begin tracking cases in the U.S. population.

The Food and Drug Administration last week added a warning to the documentation that accompanies the Pfizer and Moderna vaccines to notify recipients of the risk of developing myocarditis, seen mainly in young men.

The papers say that the vaccines may bring "increased risks of myocarditis and pericarditis, particularly following the second dose."

To date, the Centers for Disease Control and Prevention has tracked at least 323 cases of myocarditis in those ages 29 and below after COVID-19 vaccines, and is reviewing 148 additional cases.

In a presentation last week by the CDC's vaccine advisory panel, officials said the rate of developing myocarditis was 12.6 per 1 million people vaccinated. The CDC continues to recommend that everyone ages 12 and older receive the COVID-19 vaccine, given the risk of the illness and possibly severe complications.

CDC officials added that they had not yet determined how the vaccines cause myocarditis. But a group of researchers from the Mayo Clinic reported June 16 that the condition in patients following the mRNA vaccine did not resemble the inflammation seen in patients who have had a bad reaction to the smallpox vaccine.

"Potential mechanisms for myocarditis post-mRNA-based vaccination include a non-specific innate inflammatory response or a molecular mimicry mechanism between viral spike protein and an unknown cardiac protein," wrote Dr. Kathryn Larson.

The researchers noted that myocarditis was not reported as an adverse effect in the Phase 3 clinical trials for the mRNA vaccines, and that, other than in the case of the smallpox vaccine, "immunizations are rarely associated with hypersensitivity myocarditis."

In 2003, at least 10 military personnel and several civilians developed myocarditis after receiving the vaccine; two died of heart attacks. The CDC took steps to recommend that people diagnosed with heart disease avoid the smallpox vaccination.

As of June 11, the Defense Department had 30 cases of myocarditis among vaccinated beneficiaries, out of 4.1 million vaccines administered.
The researchers said rare side effects should not "diminish overall confidence in the value of vaccination."


But, they added, "increased attention to myocarditis as a potential adverse event following immunization is warranted."
"While the true incidence of this adverse event is unknown at this time, the presentation pattern and clinical course suggest an association with an inflammatory response to vaccination," wrote the group, led by Dr. Jay Montgomery, of Walter Reed National Military Medical Center in Bethesda, Maryland.
 

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Japan finds black particles in Moderna vaccine

01 Sept 2021

1630586672700.png

Several black particles were found in one vial of the vaccine by a pharmacist

Japan has put a batch of Moderna's Covid-19 vaccine on hold after a foreign substance was found in a vial.
A pharmacist saw several black particles in one vial of the vaccine in Kanagawa Prefecture, according to authorities.

Some 3,790 people had already received shots from the batch. The rest of the batch has now been put on hold.

It comes less than a week after Japan suspended the use of about 1.63 million Moderna doses due to contamination.

The pharmacist found the black particles while checking for foreign substances before the vaccine's use.

The jab's domestic distributor has collected the vial suspected to be contaminated.

Local media reports say there is no evidence so far of any health hazards caused by the potentially contaminated vaccine.

Takeda Pharmaceutical, which sells and distributes the vaccine in Japan, had just last week put three batches of the vaccine on hold after "foreign materials" were found in some doses of a batch of roughly 560,000 vials.

Spanish pharmaceutical firm Rovi, which bottles the vaccine, said in a statement that a manufacturing line in Spain could be the cause of the issue.

It added that it was conducting an investigation.

On Tuesday, Japan's health minister said foreign matter found in jabs in the southern prefecture of Okinawa were due to needles being incorrectly inserted into vials.

Japan is battling a spike in Covid cases while it hosts the Paralympic Games.

Its vaccination roll-out has been relatively slow, with just over 40% of Japanese people fully vaccinated and around 50% having received one dose.
 

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Japan finds black particles in Moderna vaccine

01 Sept 2021

View attachment 18259
Several black particles were found in one vial of the vaccine by a pharmacist

Japan has put a batch of Moderna's Covid-19 vaccine on hold after a foreign substance was found in a vial.
A pharmacist saw several black particles in one vial of the vaccine in Kanagawa Prefecture, according to authorities.

Some 3,790 people had already received shots from the batch. The rest of the batch has now been put on hold.

It comes less than a week after Japan suspended the use of about 1.63 million Moderna doses due to contamination.

The pharmacist found the black particles while checking for foreign substances before the vaccine's use.

The jab's domestic distributor has collected the vial suspected to be contaminated.

Local media reports say there is no evidence so far of any health hazards caused by the potentially contaminated vaccine.

Takeda Pharmaceutical, which sells and distributes the vaccine in Japan, had just last week put three batches of the vaccine on hold after "foreign materials" were found in some doses of a batch of roughly 560,000 vials.

Spanish pharmaceutical firm Rovi, which bottles the vaccine, said in a statement that a manufacturing line in Spain could be the cause of the issue.

It added that it was conducting an investigation.

On Tuesday, Japan's health minister said foreign matter found in jabs in the southern prefecture of Okinawa were due to needles being incorrectly inserted into vials.

Japan is battling a spike in Covid cases while it hosts the Paralympic Games.

Its vaccination roll-out has been relatively slow, with just over 40% of Japanese people fully vaccinated and around 50% having received one dose.

It's incidents like these that provide ammunition to the anti-vaxx crowd.
 
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