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EU throws weight behind Pfizer-BioNTech and new technology

Associated Press

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EU throws weight behind Pfizer-BioNTech and new technology

In a stinging rebuke to pharma giant AstraZeneca Wednesday, the European Union announced plans to negotiate a massive contract extension for Pfizer-BioNTech’s COVID-19 vaccine insisting the 27-nation bloc had to go with companies that had shown their value in the pandemic.

“We need to focus on technologies that have proven their worth,” said EU Commission President Ursula von der Leyen. She also announced that America’s Pfizer and Germany’s BioNTech would provide the EU with an extra 50 million doses in the 2nd quarter of this year, making up for faltering deliveries of AstraZeneca.

In contrast to the oft-criticized Anglo-Swedish company, von der Leyen said Pfizer-BioNTech “has proven to be a reliable partner. It has delivered on its commitments, and it is responsive to our needs. This is to the immediate benefit of EU citizens.”

Exacerbating the problems for AstraZeneca, Denmark decided Wednesday not to resume use of its vaccine, after putting it on hold last month following reports of rare blood clots in some recipients. The bulk of the shots given in the Scandinavian country so far have been the Pfizer-BioNTech vaccine.

The Johnson & Johnson jab, which uses the same base technology as AstraZeneca, hit a snag this week when U.S. regulators recommended a “pause” in administering Johnson & Johnson shots. Deliveries in the EU have been suspended.

AstraZeneca was supposed to be the workhorse of the EU’s vaccine drive this year — a cheap and easy-to-transport shot to break the pandemic’s back. Yet, the EU said that out of 120 million doses promised for the 1st quarter, only 30 million were delivered, and, of the 180 million expected, now there are only 70 million set for delivery in the 2nd quarter.

Because of that shortfall, the EU has come under crushing pressure as, even though it it is a major producer and exporter of vaccines, it cannot get its vaccinations even close to the levels of the United Kingdom and the United States.

The Our World in Data site said 47.5% of people in the U.K. have received at least one dose of COVID-19 vaccine, compared to 36.6% in the U.S. and 16.4% in the EU.

Now, Pfizer-BioNTech could well become the key to beat the pandemic on the continent.

With 200 million doses already earmarked for the bloc this quarter from Pfizer-BioNTech. the 50 million additional deliveries will be especially welcomed by EU nations dealing with supply delays and concerns over rare blood clots potentially linked to the Oxford-AstraZeneca vaccine.

Von der Leyen said the EU will start negotiating to buy 1.8 billion doses of the Pfizer-BioNTech vaccine through 2023.

“It will entail that not only the production of the vaccines, but also all essential components, will be based in the EU,” von der Leyen said.

The European Commission currently has a portfolio of 2.3 billion doses from half a dozen companies and is negotiating more contracts.

Von der Leyen expressed full confidence in the technology used for the Pfizer-BioNTech vaccine, which is different from that behind the Oxford-AstraZeneca vaccine.

The active ingredient in the Pfizer-BioNTech shot is messenger RNA, or mRNA, which contains the instructions for human cells to construct a harmless piece of the coronavirus called the spike protein. The human immune system recognizes the spike protein as foreign, allowing it to mount a response against the virus upon infection.

Astra Zeneca’s is made with a cold virus that sneaks the spike protein gene into the body. It’s a very different form of manufacturing: Living cells in giant bioreactors grow that cold virus, which is extracted and purified.

Von der Leyen said Europe needs to have a technology that can boost immunity, tackle new variants and produce shots quickly and massively. “mRNA vaccines are a clear case in point,” she said.

The planned negotiations with Pfizer left in the middle what the EU would do about any new contracts with AstraZeneca. “Other contracts, with other companies, may follow,” said von der Leyen.


BRUSSELS (AP) — By RAF CASERT Associated Press
Jan M. Olsen contributed from Copenhagen.

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Sleep therapy device raises over $315.38 in crowdfunding

Karim Husami

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A UK-designed sleep therapy solution with global ambitions raised over $314.21 in the first week of a Crowdcube crowdfunding campaign.

SleepCogni, a portable device with data support for people suffering from insomnia, has so far attracted funds from 157 different investors in this latest fundraiser that combines venture capital investments and crowdfunding.

The firm’s latest lenders include Chasnay ​​Capital Investments, a new private investment fund founded by three former senior executives from General Electric (GE) Healthcare.

Co-founded by Sheffield-based entrepreneur Richard Mills, who has personally suffered from sleeping disorders, and Dutch chronobiologist and sleep expert, Dr Maan van de Werken, said the device allows users to self-manage their insomnia, a condition which affects one in three people across the world.

“Our successful crowdfund campaign builds on the momentum of last month’s FDA registration and the completion of clinical trials where SleepCogni achieved extraordinary results reducing clinical insomnia in just seven days.”

Reinaldo Garcia from Chasnay Capital Investments added: “We’re excited by our investment into SleepCogni for many reasons: its patented technology and clinically validated solution addresses an unmet need in the global sleep aid market, and the company is backed by an excellent team. As experienced global senior leaders with a proven track record, we can add value in this next exciting stage of the business and help SleepCogni scale on a global level.”

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Pfizer vaccine efficacy falls to 84% after 6 months

Hala Turk

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Pfizer and BioNTech published on Wednesday new data indicating their COVID-19 vaccine efficacy decline from 96 percent to 84 percent over six months.

These numbers are regarded as a big motivator to the drug makers currently developing a third “booster shot” to target the Indian Delta variant. 

The released data shows that the antibody levels are much higher against the Alpha coronavirus variant and the South African Beta variant, after a third dose.

Based on the figures, the efficacy “declined gradually” as it dropped from 96 percent during the first week to around two months after receiving a second jab. The dose’s effectiveness then plummeted to 83.7 percent four to six months later with an average drop of 6 percent over the last two months.

The findings may be considered by U.S. health authorities in deciding when the pair’s booster shot might be needed.

The data, which involved tests of 23 people, was published by Pfizer and has not been peer reviewed by the scientific community.

The announcement of the data and was released on the day of the company’s earnings call.

During the call, Mikael Dolsten chief scientific officers described the new data on a third dose of vaccine “encouraging.”

“Receiving a third dose more than six months after vaccination, when protection may be beginning to wane, was estimated to potentially boost the neutralizing antibody titers in participants in this study to up to 100 times higher post-dose three compared to pre-dose three,” Dolsten said in a statement.

Despite Pfizer and its German partner BioNTech’s booster shot plans, both Centers for Disease Control and Prevention (CDC) as well as Food and Drug Administration (FDA) released a joint statement highlighting that Americans who have been fully vaccinated do not need a booster shot at this moment in time.

The statement noted that FDA, CDC, and National Institutes of Health (NIH) are engaged in a science-based process to consider whether or when a booster might be necessary.

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Google delays return to office, mandates vaccines

Associated Press

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Google delays return to office, mandates vaccines

Google is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened.

The more highly contagious delta variant of the coronavirus is driving a dramatic spike in COVID-19 cases and hospitalizations. Google’s Wednesday announcement was shortly followed by Facebook, which also said it will make vaccines mandatory for U.S. employees who work in offices. Exceptions will be made for medical and other reasons.

In an email sent to Google’s more than 130,000 employees worldwide, CEO Sundar Pichai said the company is now aiming to have most of its workforce back to its offices beginning Oct. 18 instead of its previous target date of Sept. 1.

The decision also affects tens of thousands of contractors who Google intends to continue to pay while access to its campuses remains limited.

“This extension will allow us time to ramp back into work while providing flexibility for those who need it,” Pichai wrote.

And Pichai disclosed that once offices are fully reopened, everyone working there will have to be vaccinated. The requirement will be first imposed at Google’s Mountain View, California, headquarters and other U.S. offices, before being extended to the more than 40 other countries where Google operates.

“This is the stuff that needs to be done, because otherwise we are endangering workers and their families,” said Dr. Leana Wen, a public health professor at George Washington University and a former health commissioner for the city of Baltimore. “It is not fair to parents to be expected to come back to work and sit shoulder-to-shoulder with unvaccinated people who could be carrying a potentially deadly virus.”

Because children under the age of 12 aren’t currently eligible to be vaccinated, parents can bring the virus home to them from the office if they are around unvaccinated colleagues, Wen said.

Various government agencies already have announced demands for all their employees to be vaccinated, but the corporate world so far has been taking a more measured approach, even though most lawyers believe the mandates are legal.

Delta and United airlines are requiring new employees to show proof of vaccination. Goldman Sachs and Morgan Stanley are requiring their employees to disclose their vaccination status, but are not requiring staffers to be vaccinated.

Less than 10% of employers have said they intend to require all employees to be vaccinated, based on periodic surveys by the research firm Gartner.

While other major technology companies may follow suit now that Google and Facebook have taken stands on vaccines, employers in other industries still may be reluctant, predicted Brian Kropp, chief of research for Gartner’s human resources practice.

“Google is seen as being such a different kind of company that I think it’s going to take one or two more big employers to do something similar in terms of becoming a game changer,” Kropp said.

Google’s vaccine mandate will be adjusted to adhere to the laws and regulations of each location, Pichai wrote, and exceptions will be made for medical and other “protected” reasons.

“Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead,” Pichai explained.

Google’s decision to require employees working in the office to be vaccinated comes on the heels of similar moves affecting hundreds of thousands government workers in California and New York as part of stepped-up measures to fight the delta variant. President Joe Biden also is considering mandating all federal government workers be vaccinated.

The rapid rise in cases during the past month has prompted more public health officials to urge stricter measures to help overcome vaccine skepticism and misinformation.

The vaccine requirement rolling out in California next month covers more than 240,000 government employees. The city and county of San Francisco is also requiring its roughly 35,000 workers to be vaccinated or risk disciplinary action after the Food and Drug Administration approves one of the vaccines now being distributed under an emergency order.

It’s unclear how many of Google’s workers still haven’t been vaccinated. In his email, Pichai described the vaccination rate at the company as high.

Google’s decision to extend its remote-work follows a similar move by another technology powerhouse, Apple, which recently moved its return-to-office plans from September to October, too.

The delays by Apple and Google could influence other major employers to take similar precautions, given that the technology industry has been at the forefront of the shift to remote work triggered by the spread of the novel coronavirus.

Even before the World Health Organization declared a pandemic in March 2020, Google, Apple and many other prominent tech firms had been telling their employees to work from home. This marks the third time Google has pushed back the date for fully reopening its offices.

Google’s vaccine requirement also could embolden other employers to issue similar mandates to guard against outbreaks and minimize the need to wear masks in the office.

While most companies are planning to bring back their workers at least a few days a week, others in the tech industry have decided to let employees do their jobs from remote locations permanently.


SAN RAMON, Calif. (AP)

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