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J&J single dose COVID-19 vaccine receives FDA emergency use authorization

Inside Telecom Staff

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single dose COVID-19 vaccine

Johnson & Johnson’s single dose COVID-19 vaccine has received its Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to prevent COVID-19 in individuals 18 years of age and older.   

The vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, and received authorization based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

According to a company statement, J&J will look to make its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccines to the U.S. government and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “A vaccine that protects against COVID-19, especially against the severe outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

The company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. “The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines,” the statement read.

In parallel, J&J recently announced its submission of a European Conditional Marketing Authorization Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single dose COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

According to the company, the vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C).

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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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Vaccine maker BioNTech to use mRNA tech to target malaria

Associated Press

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Vaccine maker BioNTech to use mRNA tech to target malaria

Pharmaceutical company BioNTech said Monday that it wants to use the mRNA technology behind its coronavirus vaccine to target malaria.

The Germany-based company, which developed the first widely approved coronavirus shot together with U.S. partner Pfizer, aims to begin clinical trials for a “safe and highly effective malaria vaccine” by the end of next year.

“We are already working on HIV and and tuberculosis, and malaria is the third big indication (disease) with a high unmet medical need,” BioNTech’s chief executive, Ugur Sahin, told The Associated Press. “It has an incredible high number of people being infected every year, a high number of patients dying, a particularly severe disease and high mortality in small children.”

According to the World Health Organization, there were about 229 million cases of malaria worldwide in 2019. The global body estimates that 409,000 people died from malaria that year, with children under the age of 5 accounting for 67% of deaths.

Africa has by far the highest burden of the mosquito-borne disease worldwide, WHO says.

Sahin acknowledged that the effort is at a very early stage and there’s no guarantee of success. But he said the company believes it’s “the perfect time to address this challenge” because of the insights it has gained from developing an mRNA vaccine against the coronavirus and a growing understanding of how malaria works.

Experts say developing a vaccine to prime the immune system against malaria will be tricky, however.

“The genome of Plasmodium, the parasite that causes malaria, is more complex than viruses,” said Prakash Srinivasan, an assistant professor at Johns Hopkins Bloomberg School of Public Health.

A malaria vaccine made by drugmaker GlaxoSmithKline already being trialed in three African countries has shown that inducing strong, long-lasting antibody levels is challenging, he said.

Existing and future variants of the parasite could also pose a challenge to developing an effective vaccine, said Srinivasan, whose lab is also working to develop a shot against malaria.

But Barton Haynes, director of the Duke Human Vaccine Institute, said the experience of the COVID-19 pandemic showed mRNA technology could be used to quickly adapt vaccines to work against new variants.

“The mRNA platform is going to be applicable to many different pathogens,” he said.

Sahin said early-stage development and testing of vaccines normally costs about $30-80 million.

The project, which is a collaboration with the World Health Organization, the European Commission and the Bill and Melinda Gates Foundation, “has no budget limits at the moment,” he added.

BioNTech said it is also seeking to establish an mRNA vaccine production facility in Africa, which is among the regions that have struggled to get sufficient supply of COVID-19 vaccine doses.

The company said it is working with partners to “evaluate how to establish sustainable mRNA manufacturing capabilities on the African continent to supply African countries with vaccines.” Once built, such a facility would be able to make various mRNA-based vaccines.

BioNTech and Pfizer have said they will deliver 1 billion doses of their COVID-19 vaccine to middle- and low-income countries this year, and another billion doses in 2022.

Last week, the two companies announced that a South African firm, the Biovac Institute, will become the first on the continent to start producing their coronavirus vaccine.

BioNTech has previously said it is working on a vaccine candidate for tuberculosis, with clinical trials aimed for 2022, and therapies for several forms of cancer.


BERLIN (AP)

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