FDA OKs limited access to Profound Medical's Sonalleve device for bone tumor

 

• The FDA has signed off on a Humanitarian Device Exemption (HDE) for Profound Medical's (PROF +5.4%) Sonalleve system for the treatment of osteoid osteoma, a benign bone tumor that occurs in children and young adults.
• HDE, aimed at facilitating the development of medical devices for rare diseases affecting pediatric patients, allows for the sale of a certain number of devices at a profit prior to full approval. In this case, the ceiling, called the annual distribution number, is 8,000 units.
• https://seekingalpha.com/news/3640010-fda-oks-limited-access-to-profound-medicals-sonalleve-device-for-type-of-bone-tumor

Baltimore County Schools Closed Monday, Tuesday Due To Ransomware Attack

 Well, it's becoming evident in Baltimore, Maryland, that teaching remotely in the pandemic is not sustainable as hackers have hit Baltimore County Public Schools (BCPS) with a ransomware attack, forcing the school system to close schools for Monday and Tuesday, reported CBS Baltimore. 

"Due to the recent ransomware attack, Baltimore County Public Schools will be closed for students on Monday, November 30, and Tuesday, December 1. BCPS offices will be open and staff will receive additional information about Monday and Tuesday," BCPS tweeted.

In another post, BCPS said, "this provides much-needed time for our staff to continue working on setting up the instructional platform and to communicate next steps regarding devices. On Mon. and Wed., free student meals will be available at 300+ locations as usual, including all middle and high schools."

The school system ended the statement by saying, "We understand how challenging this situation is for families and staff, and we thank you for your patience as we work through this crisis. Please note that future daily updates will be available at 5 pm."

On Friday, the 11 News I-Team reported that Maryland state auditors found significant risks within the BCPS network.

Days before the ransomware attack was discovered, early last week, findings from the Office of Legislative Audits showed BCPS did not properly secure sensitive personal information. 

At the moment, there's still no source behind the ransomware attack or much money hackers want to restore computer network systems. 

Last month, the public school system in Yazoo County, Mississippi, revealed that it paid upwards of $300k to help recover its network that was overrun by a ransomware incident.

There have been major US hospital systems hit with "paralyzing" ransomware attacks this fall. 

So the real consequence of a school system going offline because of a ransomware attack is that children may not be able to learn for as long as the systems are down - as seen in Baltimore this week.  

https://www.zerohedge.com/technology/baltimore-county-schools-closed-monday-tuesday-due-ransomeware-attack

Russian hospital says it began civilian coronavirus vaccinations last week

 Russia has delivered the first known batch of Sputnik V vaccines for civilian use to a hospital just south of Moscow, which said on Monday it began vaccinating the local population last week.

Russia, which is rushing to keep up with Western drugmakers in the race for a coronavirus shot, has said interim trial results show its Sputnik V vaccine to be 92% effective at protecting people from COVID-19.

Domodedovo’s Central City Hospital said on its website that residents wanting for inoculation had to register on a government website in advance and bring along a negative COVID-19 test result and ID documents on the day.

Coronavirus cases have surged in Russia since September, but authorities have resisted imposing a tough lockdown and have said that targeted measures are enough to cope with the crisis.

Authorities confirmed 26,338 new coronavirus cases on Monday, including 6,511 in Moscow and 3,691 in St Petersburg, taking the national total to 2,295,654 since the pandemic began.

They also reported 368 deaths in the last 24 hours, pushing the official death toll to 39,895.

https://www.reuters.com/article/us-health-coronavirus-russia-sputnik/russian-hospital-says-it-began-civilian-coronavirus-vaccinations-last-week-idUSKBN28A1TW

No COVID-19 vaccine, no normal life, UK minister suggests

 People who refuse a vaccine for COVID-19 could find normal life curtailed as restaurants, bars, cinemas and sports venues could block entry to those who don’t have proof they are inoculated, Britain’s new vaccine minister said on Monday.

Several major COVID-19 vaccines have been announced in recent weeks, raising hopes that the world could soon return to some semblance of normality after the coronavirus killed 1.46 million people and wiped out a chunk of the global economy.

The British minister responsible for the vaccine rollout, Nadhim Zahawi, said getting vaccinated should be voluntary but that Google, Facebook and Twitter should do more to fact-check opposing views of vaccines.

Asked by the BBC if there would be an immunity passport, Zahawi said a person’s COVID-19 vaccine status might be included in a phone app that would inform local doctors of a person’s status.

“But also I think you’d probably find that restaurants and bars and cinemas and other venues, sports venues, will probably also use that system as they’ve done with the app,” Zahawi told the BBC.

“The sort of pressure will come both ways: from service providers - who will say ‘look, demonstrate to us that you have been vaccinated’ - but also we will make the technology as easy and accessible as possible.”

Health authorities in many countries have become increasingly concerned in recent years by the growth of anti-vaccine groups, which are especially active on social media.

Asked if it would become virtually impossible to do anything without the vaccine, Zahawi said: “I think people have to make a decision but I think you’ll probably find many service providers will want to engage in this in the way they did with the app.”

Zahawi declined to give any specific date on a vaccine rollout as none have yet been approved for public use.

The message, he said, should be that a vaccine is good for the community and the country.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/no-covid-19-vaccine-no-normal-life-uk-minister-suggests-idUSKBN28A24O

UK appoints COVID-19 vaccine rollout minister as country preps for launch

 The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine.

According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine.

According to the Financial Times, the MHRA could approve the vaccine by 7^th December after the companies announced supportive data from a phase 3 trial mid-way through November.

Zahawi will therefore face the difficult task of overseeing distribution arrangements for the shot, which must be stored at around -70c during transit to retain its integrity.

A minister for business and industry, Zahari will temporarily relinquish responsibility for most of his duties at the Department for Business, Energy and Industrial Strategy (BEIS).

The interim arrangement will see the MP for Stratford-on-Avon serve as a joint minister between the BEIS and the Department for Health and Social Care.

The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

The UK has ordered 40 million doses of the two-shot product, which could be up to 95% effective in preventing diseases, according to the companies’ top-line data.

Although the European Medicines Agency technically has authority to authorise medicines for the UK until December 31 under Brexit transition arrangements, the MHRA can temporarily authorise products in cases of urgent need.

The government has also written to the MHRA, asking it to use the same process to authorise the rival vaccine from AstraZeneca and Oxford University.

As reported by pharmaphorum, the MHRA’s forthcoming spilt from the EMA could potentially allow it to be more agile in its decision-making after Brexit.

Emergency approval is also expected in the US next week, the FT added, with shipments starting across the country within 24 hours of the announcement.

https://pharmaphorum.com/news/uk-appoints-vaccine-rollout-minister-as-country-preps-for-swift-approval/

Moderna takes its Covid-19 vaccine to the FDA

 The full results are in, and Moderna’s Covid-19 vaccine candidate, mRNA-1273, is on its way to regulators after showing efficacy of 94.1% in its pivotal trial. The final data from the Cove study are in line with the 94.5% shown at the interim analysis, and the 95% reported for Pfizer/Biotech’s rival, BNT162b2.

Still, investors are bound to look for differences between the projects, and one thing Moderna bulls can latch on to is severe Covid-19 infection – or the lack of it. There have still been no severe cases of Covid-19 in subjects receiving mRNA-1273, while there was one in the active cohort of BNT162b2’s pivotal trial.

Moderna's stock was up as much as 16% this morning, taking its market cap to nearly $59bn. But this is a win-win situation, with Biontech and Pfizer up 5% and 2% respectively.

Of course, the complete, peer-reviewed datasets on both vaccines still need to be scrutinised. Of particular interest will be how efficacy breaks down across different age groups and ethnicities. Moderna has only said that the efficacy of mRNA-1273 was consistent across these demographics. Pfizer, meanwhile, reported that its vaccine was over 94% effective in people aged over 65.

Safety will also be closely watched when the full results are available. All Moderna is saying for now is that there have been no new serious safety concerns, and that the most common adverse events included injection site pain, fatigue and headache.

Two approvals by year end?

The focus now turns to how quickly the vaccines can get approved; BNT162b2 is set to go before an FDA panel on December 10, while mRNA-1273’s adcom will likely be on December 17, Moderna confirmed today. Rolling reviews for mRNA-1273 have already begun in the EU, Canada, Switzerland, the UK, Israel and Singapore.

Swift approvals would be good news for investors and governments alike, but perhaps not so much for another Covid-19 vaccine developer, Novavax, which has again delayed the start of its US pivotal trial of NVX‑CoV2373. This was once pegged to start in October, was then delayed until the end of November, and is now slated to begin in “the coming weeks”.

Recruiting participants could be tough if there are already vaccines on the market; Novavax shares slumped 2% this morning. Astrazeneca might also face a similar problem: the UK group is reportedly planning a new global study, to test a half-dose/full-dose regimen of its candidate, AZD1222.

Company	Biontech/Pfizer	Moderna
Project	BNT162b2	mRNA-1273
Pivotal study	NCT04368728	Cove
Dosing	Day 0 & day 21	Day 0 & day 28
Readout timing	Day 28	Day 42
Enrolment	43,538	30,000
Cases in active cohort	8 (1 severe)	11 (0 severe)
Cases in placebo cohort	162 (9 severe)	185 (30 severe)
Efficacy	95%	94%
Manufacturing capacity 2020	50m doses (global)	20m doses (US only)
Global manufacturing capacity 2021	1.3bn doses	500m to 1bn doses
Source: Company announcements and Evercore ISI. https://www.evaluate.com/vantage/articles/news/trial-results/moderna-takes-its-covid-19-vaccine-fda

FDA Covid-19 test authorisations flatline

 There is no denying that the number of emergency authorisations granted for Covid-19 tests has slowed sharply this month. Only five new tests or sample collection kits gained the FDA’s blessing over the course of November. It is hard to say why this might be. It is unlikely that diagnostics developers feel the market is saturated, since demand in the US for Covid-19 tests is so high that some test makers have reported delays – Quest Diagnostics, for example, said last week that the average turnaround time for its molecular tests had increased to 2-3 days. Perhaps development of new tests has slowed, with companies focusing more on ramping up production of assays that have already been authorised. But there are still some novel assays awaiting the FDA’s attention, such as Siemens Healthineers’ quantitative test for neutralising antibodies. The agency is gearing up to consider authorising the two leading vaccine candidates, from Pfizer/Biontech and Moderna, in December; should these get the nod, and the shots work as well as expected, the market for Covid-19 tests will slowly diminish across 2021. But currently demand is strong amid the autumn surge. An increase in the rate of test authorisations would be no bad thing.

 Other: 7

Note: "Other" includes seven antigen tests, six home sampling kits, three saliva collection devices and two IL-6 tests. 

https://www.evaluate.com/vantage/articles/news/snippets/fda-covid-19-test-authorisations-flatline