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Corona Virus Vaccines

mtime7

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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.
 

BATMAN

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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".
 

mtime7

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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

2 hours ago


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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