QIAGEN to Resubmit QIAreach SARS-CoV-2 Antigen Test in Q1

 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it plans to resubmit in the first quarter of 2021 its QIAreach SARS-CoV-2 Antigen Test to the U.S. Food and Drug Administration for Emergency Use Authorization to detect SARS-CoV-2 antigens in people with active infections in 15 minutes.

This comes after QIAGEN decided to proactively withdraw the first submission made in November 2020 for this product to address a chemistry-related issue. QIAGEN believes it has resolved the issue, and data is now being collected for submission to the FDA. The eHub used to read out test results is not affected.

“We are working closely with the FDA to ensure that all necessary information is submitted as quickly as possible so that we can make this product available as a solution in the fight against the COVID-19 pandemic, as many U.S. customers have expressed significant interest in using QIAreach to expand their testing capacity,” said Thierry Bernard, Chief Executive Officer of QIAGEN.

https://www.biospace.com/article/releases/qiagen-plans-to-resubmit-eua-submission-in-the-u-s-for-qiareach-sars-cov-2-antigen-test-in-the-first-quarter-of-2021/

Calif.: Moderna vax batch 'safe' following reports of illness

 California on Wednesday said it’s safe to resume using a batch of Moderna coronavirus vaccine after some people fell ill and a halt to injections was recommended.

The decision frees up more than 300,000 doses to counties, cities and hospitals struggling to obtain supplies. The state Department of Public Health on Sunday urged a pause in the use of a specific lot after fewer than 10 people who received shots at a San Diego vaccination site needed medical care, possibly due to rare but severe allergic reactions.

But after a safety review and consultation with Moderna and local and federal health agencies, the state “found no scientific basis to continue the pause” and said vaccinations can “immediately resume,” state epidemiologist Dr. Erica Pan said in a statement.

“These findings should continue to give Californians confidence that vaccines are safe and effective, and that the systems put in place to ensure vaccine safety are rigorous and science-based,” Pan said, adding that some of her own family members had received it.

About 330,000 doses from the lot had been distributed to nearly 300 providers in California this month. Most had halted using it until receiving the all-clear.

Cheryl Brennan of Fallbrook was among those who fell ill shortly after being injected last week at Petco Park, home of the San Diego Padres.

“At 18 minutes, it was like my throat started closing,” she told KSWB-TV. “My blood pressure went to 185 over 125, which I guess is very life-threatening.” Help came immediately.

“They hooked up electrodes. They put ice packs on me. I had four EMTs and two nurses helping me and they brought my blood pressure back down within 45 minutes,” Brennan said.

Brennan also said despite the reaction, she plans to return next month for a second dose. The vaccine requires two shots for full immunization.

“I will still absolutely, positively go,” Brennan said. “My opinion, if I get COVID, I would probably have a lot worse reactions than just having those issues … And my husband has underlying health conditions, so it’s worth taking that chance.”

The release of the Moderna doses comes as California officials struggle to meet the challenge of vaccinating all those awaiting them, including millions of people 65 and older who recently were added to the eligibility list behind health care workers and people in nursing care homes.

California, with 40 million people, is only getting 400,000 to 500,000 doses of vaccine in a good week and it could take four to five months just to complete vaccinations for those 65 and older, Pan said during a state vaccine advisory committee meeting, according to the Sacramento Bee.

Despite such concerns, large counties have been opening up more mass vaccination sites as they struggle with an unprecedented demand. Officials are pinning their hopes on President Joe Biden’s promise to ramp up resources for vaccination.

“Under a Biden administration, our country has a fighting chance at defeating this virus,” California state Sen. Scott Wiener said Wednesday.

Providers place vaccine orders that are reviewed by the state and submitted to the federal government, which can authorize the order and submit the request to the vaccine manufacturer. Counties have complained about lag times and unpredictability in distribution.

More than 4 million doses had been shipped and about 1.5 million had been administered as of Tuesday, according to figures from the state public health department. Health officials have said the delay may be due in part to some doses not actually having arrived in the state yet.

With the all-clear for Moderna’s vaccine, San Francisco will be able to use 8,000 doses it had put on hold and no longer expects to run out of vaccine on Thursday as previously feared, the San Francisco Chronicle reported. Health officials had received fewer than 2,000 additional doses this week for city hospitals and community clinics.

The city hopes to have an estimated 900,000 people who live or work in the city to be vaccinated by June 30, although it would have to double or triple its vaccination rate to 10,000 a day.

“The chief obstacle we are facing is not enough doses,” said Roland Pickens, director of San Francisco’s public health care system, at a supervisors’ hearing Wednesday. “You only get it one way; you get it for free and you get it from the federal government.”

Los Angeles County, with a quarter of the state’s population, was straightening out early problems with online and call-in systems that residents over 65 can use to make a reservation for vaccination, said Barbara Ferrer, director of the county Department of Public Health.

But the real problem was supply. Ferrer said more than 70% of the doses received for next week are already earmarked for people who are getting their second shots.

Former Gov. Arnold Schwarzenegger put in a pitch for vaccination, posting a Twitter video of himself getting a shot in his right bicep at the drive-through site at Dodger Stadium.

“Today was a good day,” he wrote. “I have never been happier to wait in a line. If you’re eligible, join me and sign up to get your vaccine. Come with me if you want to live!”

Meanwhile, California reported its second-highest number of COVID-19 deaths Wednesday but also a dip in hospitalizations below 20,000 for the first time since Dec. 27.

The total of 694 new deaths is second to the record 708 reported Jan. 8, according to the state Department of Public Health.

California this week surpassed 3 million COVID-19 cases since the pandemic began early last year. Nearly 35,000 people have died, according to data compiled by Johns Hopkins University.

Most of the state’s population still was under stay-at-home orders triggered by a lack of intensive care beds to handle COVID-19 patients. The spike was blamed on people ignoring social distancing and mask-wearing while gathering for the holidays.

Only a couple of weeks ago, it was feared hospitals in hard-hit areas might have to begin rationing care. But statewide hospitalizations have dipped 8.5% over 14 days, with the number of intensive care patients also easing.

–– ADVERTISEMENT ––

In another bit of good news, the statewide positivity for the virus over a seven-day period has fallen below 10% for the first time in weeks — meaning statistically that each infected individual was now infecting less than one other person.

https://nypost.com/2021/01/21/california-ok-to-use-moderna-vaccine-after-illness-reports/

NICE recommends Galapagos filgotinib on NHS for rheumatoid arthritis

 

• NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible¹
• More than 400,000 people across the UK live with RA² and around 70% have moderate or severe disease³

https://www.globenewswire.com/news-release/2021/01/21/2161865/0/en/NICE-recommends-Jyseleca-filgotinib-on-NHS-in-landmark-decision-for-rheumatoid-arthritis.html

Boston Scientific To Buy Preventice Solutions For Up To $1.23B

Boston Scientific (BSX) said Thursday that it agreed to buy Preventice Solutions Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors to cardiac event monitors and mobile cardiac telemetry.

The deal consists of an upfront cash payment of $925 million, and up to an additional $300 million in a potential commercial milestone payment.

Boston Scientific has been an investor in Preventice since 2015 and currently holds an equity stake of about 22 percent, which is expected to result in a net payment of about $720 million upon closing and a milestone payment of up to about $230 million.

The company expects to close the deal by mid-2021 and expects the deal to be immaterial to adjusted earnings per share in 2021, accretive by at least one cent in 2022, and increasingly accretive thereafter.

https://www.nasdaq.com/articles/boston-scientific-to-buy-preventice-solutions-for-up-to-%241.23-bln-2021-01-21

'Real-world' analysis of covid vax in Israel raises questions on UK strategy

 The first real-world analysis of the Pfizer/BioNTech coronavirus vaccine suggests it is matching its performance in clinical trials, but raises serious questions about the UK's decision to delay the second dose.

Scientists in Israel - which is leading the COVID-19 vaccination race - have told Sky News that they are "very hopeful" having studied preliminary data from 200,000 vaccinated people.

But crucially they say their results do not show efficacy at a level close to that used by the UK to justify delaying the second dose of the Pfizer/BioNtech jab.

Professor Ran Balicer is a physician, epidemiologist and chief innovation officer for Clalit, the largest health care provider in Israel. He is also an adviser to the World Health Organisation.

"We compared 200,000 people above the age of 60 that were vaccinated. We took a comparison group of 200,000 people, same age, not vaccinated, that were matched to this group on various variables..." Prof Balicer said.

"Then we looked to see what is the daily positivity rate... And we saw that there was no difference between vaccinated and unvaccinated until day 14 post-vaccination.

"But on day 14 post-vaccination, a drop of 33% in positivity was witnessed in the vaccinated group and not in the unvaccinated... this is really good news."

However, UK scientists said in December that trial data had suggested it would be 89% effective after one dose.

A document issued by the UK government's vaccine advisers, the Joint Committee on Vaccination and Immunisation, to justify delaying the second dose for up to 12 weeks said: "Using data for those cases observed between day 15 and 21, efficacy against symptomatic COVID-19 was estimated at 89%, suggesting that short term protection from dose 1 is very high from day 14 after vaccination."

This is much more optimistic than the new real-world Israeli data suggests.

Responding to the UK government strategy, Prof Balicer said: "The data and estimates I gave are what we have.

"We could not see 89% reduction in the data we reported. Further data and analyses will be released in peer reviewer scientific format."

He added: "The practice in Israel is to provide the second vaccine at three weeks.

"And so it is impossible for us to tell what would be the impact of not providing the second dose..."

Israel is following Pfizer/BioNtech protocol in giving the second dose of the coronavirus vaccine three weeks after the first.

It has a smaller population and a regular supply from Pfizer/BioNtech. In return it's providing detailed data to Pfizer.

In contrast, the UK with a much larger population is prioritising the first jab - arguing that one dose given to as many people as possible is better than two to fewer people.

"We have already covered some 25% of our population and over 75% above the age of 60 in the last four and a half weeks.

"And so we are one of the first countries to be able to witness the sheer impact in big numbers of vaccinating such a large proportion of the population," prof Balicer said.

"By being able to manipulate this data in real time, to clean it and to use proper epidemiological methodology, we are able to provide answers to the most pertinent questions right now."

The Israeli scientists believe their 33% figure will rise when data is compiled from younger age groups and the fact that the data is real-life adds to their confidence.

"This is not the ideal setting of a randomised controlled trial where everything from coaching maintenance to selection of the population of interest is done in a very meticulous way.

"This is the real-world. And so by seeing the real world impact so early on in the same direction and in the same timing as we've seen in the clinical trials is something that makes us very hopeful."

Tel Aviv's Sourasky hospital, one of hundreds of vaccination centres, is inoculating hundreds of people an hour.

Ronni Gamzu is the hospital director. He served as the government "corona tsar" - a rotating advisory role - until last month.

"I believe, truly believe, this is the beginning of the end because the vaccine creates the immune response.

"We see that clearly and we see a change in the people that are becoming severely ill with coronavirus and moderately ill. People that have got the vaccine are more protected," Professor Gamzu said.

Asked about the UK strategy of delaying the second dose, he said the 89% figure seemed "very optimistic" but understood why compromises needed to be made.

"If you are short of vaccines, this is a good idea... We believe that if you take the booster shot, even after six weeks, then you will have an effect, the effect is coming and growing gradually.

"We do not know that for sure because the studies were done for 21 days for Pfizer and 28 days for Moderna. But there is a clear logic behind postponing it when you are short on vaccines."

In a previous statement on the decision, the JCVI said: "With most vaccines an extended interval between the prime and booster doses leads to a better immune response to the booster dose.

"There is evidence that a longer interval between the first and second doses promotes a stronger immune response with the AstraZeneca vaccine.

"There is currently no strong evidence to expect that the immune response from the Pfizer-BioNTech and AstraZeneca vaccines differ substantially from each other.

"The committee advises initially prioritising delivery of the first vaccine dose as this is highly likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19."

https://news.sky.com/story/covid-19-real-world-analysis-of-vaccine-in-israel-raises-questions-about-uk-strategy-12192751

New COVID Variant Defeats Plasma Treatment, May Cut Vaccine Efficacy

 The new COVID-19 variant identified in South Africa can evade the antibodies that attack it in treatments using blood plasma from previously recovered patients, and may reduce the efficacy of the current line of vaccines, scientists said on Wednesday.

Researchers are racing to establish whether the vaccines currently being rolled out across the globe are effective against the so-called 501Y.V2 variant, identified by South African genomics experts late last year in Nelson Mandela Bay.

"This lineage exhibits complete escape from three classes of therapeutically relevant monoclonal antibodies," the team of scientists from three South African universities working with the National Institute for Communicable Diseases (NICD) wrote in a paper published in the bioRxiv journal.

"Furthermore, 501Y.V2 shows substantial or complete escape from neutralising antibodies in COVID-19 convalescent plasma," they wrote, adding that their conclusions "highlight the prospect of reinfection ... and may foreshadow reduced efficacy of current spike-based vaccines."

The 501Y.V2 variant is 50% more infectious than previous ones, South African researchers said this week. It has already spread to at least 20 countries since being reported to the World Health Organisation in late December.

It is one of several new variants discovered in recent months, including others first found in England and Brazil.

The variant is the main driver of South Africa's second wave of COVID-19 infections, which hit a new daily peak above 21,000 cases earlier this month, far above the first wave, before falling to about 12,000 a day.

Convalescent blood plasma from previous patients has not been shown to be effective when administered to severely ill patients requiring intensive care for COVID-19, but it is approved in several countries as an emergency measure.

British scientists and politicians have expressed concern that vaccines currently being deployed or in development could be less effective against the variant.

The paper said it remained to be seen how effective current vaccines were against 501Y.V2, which would only be determined by large-scale clinical trials. But results showed the need for new vaccines to be designed to tackle the evolving threat, it said.

https://www.usnews.com/news/world/articles/2021-01-20/new-covid-19-variant-defeats-plasma-treatment-may-reduce-vaccine-efficacy

Whitmer: Need '2 years to get 70% of Michiganders over 16 vaccinated'

  Governor Gretchen Whitmer announced a massive economic recovery plan for the state on Tuesday that included funding for vaccinations.

The state's goal is to get 70% of residents over the age of 16 vaccinated.

After granting the request of several states, including Michigan, to release vaccine reserves, it was reported on Friday that the Trump administration did not have any reserves, and states would not be receiving increased shipments.

Whitmer said she was "incredibly disheartened" by the news, saying it was "maddening."

After the more contagious COVID-19 variant was detected in a Washtenaw County woman, the state says it is now racing to vaccinate as many people as it can.

Whitmer said if the state continues at the pace it is currently going, which is 60,000 vaccinations a week, it will take over two years to get 70% vaccinated.

The governor's recovery plan intends to use federal funding to ramp up vaccine distribution in Michigan; the goal is to have 50,000 shots in arms per day.

"We want to run out of vaccines every day, which keeps us at the top for more vaccines," Whitmer said. "It's a race against this variant as well."

https://www.wxyz.com/news/coronavirus/whitmer-it-will-take-2-years-to-get-70-of-michiganders-over-16-vaccinated-at-current-pace