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Thursday, March 25, 2021

HHS Reveals Thousands Of Unaccompanied Minors Test Positive For COVID-19

 A Department of Health and Human Services (HHS) whistleblower has revealed to Axios that nearly 2,900 unaccompanied minors have tested positive for COVID-19 after arriving at US government shelters over the past year, according to Axios.

Of those who tested positive, just 3% are currently in isolation after arrival, according to the report, which suggests that the numbers highlight "the staggering challenges in trying to manage a child migration crisis during a pandemic, while weighing human rights and child welfare concerns against immigration laws."

Rutgers to require COVID-19 vaccinations for all on-campus students

 Rutgers University announced Thursday that it will require COVID-19 vaccines for all on-campus students who are enrolled for the 2021 fall semester.


University leaders said that assurances from the federal government that vaccines will be available for all Americans by the end of May and assessments by public health experts prompted them to adjust the vaccine requirements for the fall semester.

"We are committed to health and safety for all members of our community, and adding COVID-19 vaccination to our student immunization requirements will help provide a safer and more robust college experience for our students," Rutgers President Jonathan Holloway said.

Students may request an exemption from vaccination for medical or religious reasons, and those enrolled in fully remote online degree programs or participating in online-only continuing education programs will not be required to be vaccinated.
"Since the start of the pandemic, we have said that the safety of the Rutgers community is a shared responsibility," said Antonio Calcado, executive vice president and chief operating officer at Rutgers. "An effective vaccination program is a continuation of Rutgers' commitment to health and safety for all members of our community of more than 71,000 students, the cities we are in and the communities we serve throughout New Jersey."

As vaccine supplies are made available to the wider population, faculty and staff are strongly urged to receive the vaccine, Calcado said.

"The COVID-19 vaccines have proven to be safe and effective in preventing serious illness, hospitalization and death," said Dr. Brian Strom, chancellor of Rutgers Biomedical and Health Sciences and executive vice president for health affairs at Rutgers. "Vaccination is key to stopping the current pandemic and to the return of campus instruction and activities closer to what we were accustomed to before the pandemic drastically changed life at Rutgers."

Students enrolling at Rutgers who are under age 18 will be advised to receive the Pfizer vaccine, the only one of three vaccines currently approved in the United States that may be administered to 16- and 17-year-olds.

Pfizer, Moderna and Johnson & Johnson vaccines are approved for those 18 years and older.

In a message to the Rutgers community, Holloway, Calcado, and Prabhas Moghe, executive vice president for academic affairs, noted widespread vaccination will accelerate the return to a pre-pandemic normal on the university's campuses, including increased in-person course offerings, more on-campus events and activities and more collaboration in instructional and research projects.

Rutgers has received approval from the State of New Jersey to administer vaccines on campus to faculty, staff and students once vaccine supplies are available to the university.

More information will be forthcoming on vaccination clinic sites. However, faculty, staff and students are urged to not wait to sign up for vaccines at a Rutgers site.

"We urge all members of our community to pre-register for the vaccine on the state COVID-19 website to get vaccinated at the earliest opportunity and the first available location," Dr. Strom said.

As for why the vaccine will be mandatory for students but only encouraged for faculty and staff, the school released the following statement:

"The Rutgers data clearly reflects that students have a 60 percent to 70 percent higher positivity rate than faculty and staff. This is to be expected since they are highly mobile and highly interactive. As we strive to build the safest community in the United States, we let the data guide us as we expanded the existing vaccine requirement for students. Given that students are easily identified as a cohort creating transmission and infection, we chose to concentrate on them. Further, this is the community that goes back to their extended families and communities, and we believe that by concentrating on them we will make New Jersey safer."

Pfizer, Eli Lilly Report Unfavorable FDA Advisory Panel Vote for Tanezumab

 Pfizer Inc. and Eli Lilly & Co. announced an unfavorable vote from a joint U.S. Food and Drug Administration advisory committee on tanezumab for osteoarthritis pain.

The companies said the vote was one in favor and 19 against on the question of whether the proposed risk evaluation and mitigation strategy would ensure benefits outweigh risks.

Pfizer and Lilly said, "While we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate."

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-nbsp-Pfizer-Eli-Lilly-Report-Unfavorable-FDA-Advisory-Panel-Vote-for-Tanezumab-32790128/

EU export restrictions on COVID shots would be 'lose-lose' situation: Pfizer exec

 European Union export restrictions on COVID-19 vaccines would result in a ‘lose-lose’ situation for everyone, including EU members, a Pfizer executive said, a day after the bloc tightened oversight of shot deliveries beyond its borders.

The EU’s action would give it greater scope to block shipments to countries with higher inoculation rates such as Britain, or which are not sharing doses that they produce.

The spectre of export restrictions has many concerned, given the global nature of vaccine production, in which shots have hundreds of ingredients sourced in dozens of countries. New roadblocks for shots or raw materials could disrupt pandemic-fighting efforts as the world struggles to contain a third wave of infections, companies fear.

“We have observed these recent developments with concern,” Sabine Bruckner, Swiss country manager for Pfizer, said at a Swiss government press conference on Thursday.

“Our executive leadership has been in direct contact with the European Union. Our position has been laid out, we are very critical, we can’t support it at all,” she added.

“Should it really come to export restrictions, that would be a ‘lose-lose’ situation for everyone, also for the members of the European Union.”

The new rules set out by the European Commission, which oversees EU trade policy, expand existing measures aimed at ensuring planned exports by drugmakers do not threaten the bloc’s supply.

They add 17 previously exempt countries including Israel, Norway and Switzerland to the list of countries for which exports of EU-produced vaccines require licences. Switzerland, for instance, gets its Pfizer COVID-19 shots from a plant in Belgium.

Pfizer’s Bruckner made the comments after a Swiss vaccine summit in which Health Minister Alain Berset predicted his country would receive 10.5 million vaccines from suppliers including Pfizer and Moderna by July, enough to vaccinate everybody in Switzerland who wants a shot, he said.

https://www.reuters.com/article/us-health-coronavirus-pfizer-europe/eu-export-restrictions-on-covid-shots-would-be-lose-lose-situation-pfizer-executive-idUSKBN2BH2PG

Thermo Fisher to work with Pfizer-BioNtech on vaccine production in Italy

 Thermo Fisher Scientific said on Thursday it would work with Pfizer and BioNtech to produce their COVID-19 vaccine in Italy.

“Thermo Fisher is working as part of Pfizer’s global vaccine manufacturing network, and will provide manufacturing services in Italy for the Pfizer-BioNTech COVID-19 vaccine that will be distributed in several markets,” the company said in an emailed statement.

Thermo Fisher added it would provide sterile filling and finished product preparation services at its facility in Monza, outside Milan, during 2021.

https://www.reuters.com/article/us-health-coronavirus-italy-thermo-fishe/thermo-fisher-to-work-with-pfizer-biontech-on-vaccine-production-in-italy-idUSKBN2BH2SB

Oxford to test inhaled version of COVID-19 vaccine with 30 volunteers

 Oxford University said on Thursday it was launching a study to investigate immune responses of a nasal administration of its COVID-19 vaccine developed with AstraZeneca, with 30 health volunteers aged 18 to 40 for the initial trial.

British researchers last September said that inhaled versions of COVID-19 vaccine candidates developed by Oxford University and Imperial College will be tested to see if they deliver a localised immune response in the respiratory tract.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-vaccin/oxford-to-test-inhaled-version-of-covid-19-vaccine-with-30-volunteers-idUSKBN2BH2PS

Moderna plans factory in eastern Germany

  The U.S. coronavirus vaccine producer Moderna is planning to construct a vaccine manufacturing facility in eastern Germany, a German newspaper reported on Thursday.

The Frankfurter Allgemeine Zeitung said that the company, which produces its COVID-19 vaccine in Switzerland, will go into operation in two years’ time. The newspaper did not cite sources.

The details are still unclear, the newspaper said. It said talks over German government support for the venture have stalled because Berlin wants to make its backing contingent on bigger vaccine delivery volumes by Moderna, but Moderna cannot commit to that.

Germany’s economics ministry declined to comment on the topic, but a spokeswoman said there was a task force for vaccine production and that it was in contact with multiple companies.

https://www.reuters.com/article/us-health-coronavirus-germany-moderna/moderna-plans-factory-in-eastern-germany-faz-reports-idUSKBN2BH2UX