Indian govt permits export of 50mn doses of Covovax

 The Centre has permitted the export of around 50 million doses of Covid-19 vaccine Covovax produced by Serum Institute of India (SII) as part of a tie-up with US-based vaccine maker Novavax Inc, according to people familiar with the developments.

Covovax has not been approved yet for emergency use in India. The government approval for the export of Covovax will help avoid wastage of nearly 10 million stockpiled Covovax doses which are due to expire in December. The vaccines were produced as part of SII’s agreement with Novavax Inc. for the development and commercialisation of NVX-CoV2373.

SII chief executive officer Adar Poonawalla earlier told HT in an interview that his company intended to keep Covovax and Sputnik Light, the first component of the Russian coronavirus vaccine Sputnik V, for exports.

“That is my sort of thinking and discussion with the government; and we are sort of aligned on that because Covishield is churning out enough volumes for the country… We do not need to increase the volumes; in fact anything more we make, we hope to export…,” Poonawalla said in an interview last month.

https://www.hindustantimes.com/india-news/centre-permits-export-of-50mn-doses-of-covovax-sayofficials-101636999767020.html

India opens borders to vaccinated foreign tourists

 India opened its borders to vaccinated tourists from over 90 countries on Monday.

The Health Ministry published revised guidelines for international travelers to streamline the process of tourists entering the country.

It said foreign tourists entering India would have to be fully vaccinated or test negative for the virus within 72 hours of their flight. They would also have to follow COVID protocols at all times.

Which tourists can now enter India?

While some travelers would have to undergo COVID-19 tests on arrival, people from certain countries that have agreements with India for mutual recognition of vaccine certificates can enter India without taking a test upon arrival.

This means that travelers from several countries including the United States, the United Kingdom, and most European nations, can pass through airports across Indian cities without taking a test.

Though India allowed entry to foreign travelers on chartered flights last month, this is the first time the country has opened its borders to those arriving on commercial flights in months.

India locked down its borders March 2020, and hasn't issued foreign visas since. Now, it plans to encourage travelers to visit the country by issuing 500,000 free visas through next March. 

What is the COVID situation in India?

With more than 35 million reported infections, India is the second-worst-hit country in the world, after the US. However, 

India's daily cases have fallen significantly , with infections hovering at just above 10,000 for over a month.

Nearly 79% of India's adult population has received at least one vaccine dose, while 38% has been fully vaccinated.

https://www.dw.com/en/covid-india-opens-borders-to-vaccinated-foreign-tourists/a-59819555

9 states in Brazil, Federal District record no Covid-19 deaths in 24 hours

 Data released by the Ministry of Health show that nine states and the Federal District have not recorded deaths from Covid-19 in 24 hours. São Paulo, Minas Gerais, Goiás, Sergipe, Piauí, Rondônia, Amapá, Roraima, Acre and the Federal District had no deaths from the virus in this period.

The country recorded yesterday (8) the lowest moving average of deaths by the disease in 2021. There are 269.2 deaths on the moving average, besides 10.7 thousand cases. This is a 21% drop compared to the last 14 days.

https://www.riotimesonline.com/brazil-news/brazil/nine-states-in-brazil-and-the-federal-district-record-no-covid-19-deaths-in-24-hours/

Germany could make COVID test or vaccine mandatory for public transport

 Do you want to take the bus or train in Germany?

It may soon be necessary to provide a negative COVID-19 test or evidence of recent vaccination or recovery, as the country becomes the latest in Europe to consider drastic measures to address a new wave of cases in the region.

Germany posted another record rate of cases last week on Monday, as more indoor gatherings due to cold weather and flattened vaccination campaigns turned Europe once again into the epicenter of the pandemic.

This fourth wave of infections is challenging a government in transition, with three parties negotiating to form the next government following September’s inconclusive elections.

Center-left Social Democrats, Greens and pro-business FDP said on Monday they would add tougher measures to their bill under scrutiny by the Bundestag (lower house of parliament) to tackle the epidemic.

So-called 3G rules requiring a negative COVID-19 test or proof of recovery or vaccination should apply to public transportation and workplaces, according to a three-party policy paper.

It was not clear how they would be applied.

“To break the fourth wave quickly and forcefully we have agreed … more rules,” Senior Green MP Kathrin Goering-Eckardt said on Twitter.

However, he told reporters later that there was no agreement on mandatory vaccination in certain sectors such as nursing homes, highlighting a split in the would-be government between his party and the SPD on the one hand, and the FDP. more libertarian on the other. .

The proposal for new curbs in Germany came when the Austrian government on Monday imposed a blockade on people not vaccinated against the coronavirus. to know more

Some other European countries require passengers to provide vaccination proofs or tests for long distance travel on public transport. But it is unclear whether others require it for urban transport.

The Bundestag is expected to vote on the bill on Thursday so that it can go into effect before the expiry of the German state of emergency on November 25, which had provided the legal basis for previous measures against the pandemic.

In addition to national regulations, the new law aims to provide the 16 German states with a number of options that can be applied separately, as the infection rate varies greatly from one country to another. Higher rates can be found in regions with the lowest vaccination rates, namely eastern and southern Germany.

But the new bill excludes measures like school lockouts and curfews applied during the first waves of the pandemic, prompting criticism from some policymakers that diminish risk perception and flexibility. to know more

Germany’s vaccination rate, at 67%, is among the lowest in Western Europe, which could threaten its relatively strong performance to date in tackling the pandemic.

So far, it has recorded about 1,164 deaths per million people from COVID-19 compared to 1,828 on average in the European Union, according to data from November 14 from Our World in Data.

https://remonews.com/germanyeng/germany-could-make-covid-testing-or-vaccine-mandatory-for-public-transport/

Kezar: Interim Results from Phase 2 Lupus Trial

 

• KZR-616 demonstrates clinically meaningful benefit in patients with lupus nephritis, with 4 out of 5 patients achieving either a partial or complete renal response at end of treatment

• KZR-616 maintained a favorable safety and tolerability profile over the six-month treatment period

• Company-hosted investor and analyst conference call and webcast with guest investigator to be held today at 4:30pm ET

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported interim results from the Phase 2 portion of its MISSION clinical trial evaluating KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN).

"The MISSION Phase 2 interim results present a strong signal that KZR-616 is active and could be a meaningful therapy for patients with lupus nephritis, a long term and difficult to treat disease," said Noreen R. Henig, M.D., Kezar’s Chief Medical Officer. "Reduction in proteinuria, as quickly as possible, is an important therapeutic goal for patients with lupus nephritis, and we observed meaningful reductions at 6 months as well as encouraging data at 3 months. KZR-616 continues to appear to be immunomodulatory rather than immunosuppressive, which we believe could offer advantages over current treatments available. Based on these interim findings, we look forward to reporting top-line data in the second quarter of 2022."

https://finance.yahoo.com/news/kezar-life-sciences-announces-interim-210500176.html

CDC investigators going to University of Michigan amid flu outbreak

 Investigators from the Centers for Disease Control and Prevention (CDC) are going to the University of Michigan to look into the flu outbreak on campus and examine how the illness is spreading. 

Since the first positive flu case was detected on the Ann Arbor campus on Oct. 6, a total of 528 cases of the flu have been diagnosed at the University Health Service (UHS), according to a statement from the university.

Of those cases, 77 percent were among people who did not get a flu shot. 

UHS said the past two weeks have seen an increase in flu cases: 313 cases were reported the week of Nov. 8, with a 37 percent test positivity rate, and 198 cases were reported the week before, with a 27 percent test positivity rate.

Given the spike in cases, the university announced on Monday that starting this week, the Washtenaw County Health Department, Michigan Department of Health and Human Services, the university and a team from the CDC will start looking into the influx of cases to study how the sickness is spreading and how effective the influenza vaccine is.

 

The CDC team will conduct its study through data analysis, questionnaires and sample collections from patients at UHS.

“Through prompt detection and collaboration with county and state health officials, as well as School of Public Health and Michigan Medicine researchers, we quickly identified these cases as influenza A(H3N2) virus infections,” Lindsey Mortenson, UHS medical director and acting executive director, said in a statement.

“Partnering with the CDC will accelerate our understanding of how this flu season may unfold regionally and nationally in the setting of the COVID-19 pandemic,” she added.

The university said officials are urging the college community to get their flu vaccine, pointing to the protection it offers against severe illness, hospitalization and death, in addition to the role it plays in stopping the spread of the illness.

Juan Luis Marquez, the medical director at the Washtenaw County Health Department, said the current outbreak on Michigan’s campus is “unusual,” though it is normal to start seeing flu activity around this time.

“We’re grateful for the additional support of the CDC and our ongoing partnership with the university as we look more closely at the situation,” he added.

The university, however, said the timing of the outbreak is significant, because students are preparing to head home across the country for Thanksgiving break.

The outbreak on the university campus comes after the previous winter season saw a small number of flu cases, despite predictions that the illness would spread rapidly amid the COVID-19 pandemic.

https://thehill.com/policy/healthcare/581633-cdc-investigators-going-to-university-of-michigan-amid-flu-outbreak

NIH long-term study on children who had COVID-19 enrolls first participant

 A long-term National Institutes of Health (NIH) study on the impacts of COVID-19 on children and young adults enrolled its first participant, the agency announced on Monday.

The NIH’s research intends to follow 1,000 children and young adults aged 3-21 years old who previously tested positive for COVID-19 over three years to examine the virus’s impact on their physical and mental health, including their development and immune responses to the virus.  

The agency enrolled its first participant from its Clinical Center in Bethesda, Md., as part of the Researching COVID to Enhance Recovery (RECOVER) Initiative. Participants need parents’ or guardians’ consent to be enrolled.

Researchers will give children a physical examination, scan their hearts and other organs, and collect samples, including blood, nasal swabs, stool and urine. Children and young adult participants will have the option to determine any risk factors with genetic analysis. 

Participants who join the study more than 12 weeks after a positive test will go to the clinic every six months for three years. Those who participate within 12 weeks of a positive test will also see researchers at the three and six-month points.

The study comes after more children were hospitalized for COVID-19 amid the delta variant surge in recent months, compared to previously in the pandemic. 

Data earlier in the pandemic indicated that children were less likely to endure severe COVID-19, but at this point, almost 6 million contracted the disease and nearly 600 have died, according to Centers for Disease Control and Prevention (CDC) data. 

Many have also suffered from “significant acute and long-term effects” from COVID-19, including multisystem inflammatory syndrome in children (MIS-C).

Top infectious disease expert Anthony Fauci said scientists “still do not have a clear picture” on how COVID-19 affects children over time.

“Our investigations into the pediatric population will deepen our understanding of the public health impact that the pandemic has had and will continue to have in the months and years to come,” he said in a statement.

Children aged 5-11 years old first became eligible for the Pfizer-BioNTech vaccine earlier this month following the CDC’s recommendation for the age group. Vaccinations became available for 12-15 year olds in May. 

With fewer vaccinations among the 28 million newly eligible children, the younger population remains “especially vulnerable to infection.”

https://thehill.com/policy/healthcare/581638-nih-long-term-study-on-children-who-had-covid-19-enrolls-first-participant