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Tuesday, March 16, 2021

China approves 5th COVID-19 vaccine for emergency use

 China has approved a new COVID-19 vaccine for emergency use, one that was developed by the head of its Center for Disease Control, adding a fifth shot to its arsenal.

Gao Fu, the head of China's CDC, led the development of a protein subunit vaccine that was approved by regulators last week for emergency use, the Chinese Academy of Sciences' Institute of Microbiology said in a statement Monday.

It is the fifth coronavirus vaccine approved in China and the fourth to be given emergency use approval. Three of those given emergency approval have since been approved for general use. All were developed by Chinese companies.

The latest vaccine was developed jointly by Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. and the Chinese Academy of Sciences. The team finished phase 1 and phase 2 clinical trials in October and is currently conducting the last phase of trials in Uzbekistan, Pakistan and Indonesia, according to the statement.

The vaccine was approved for use in Uzbekistan on March 1. It's a three-dose shot that is spaced out with one month each between shots, a company spokesperson said. Like other vaccines China has developed so far, it can be stored at normal refrigeration temperatures.

There is no publicly available information in peer-reviewed scientific journals about the clinical trial data showing efficacy or safety. A spokesperson for the company said that the data could not be shared at this time but that the company was providing the information to health authorities.

The protein subunit vaccine is similar to many of the other vaccines that have been approved globally in that it trains the body to recognize the spike protein that covers the surface of the coronavirus, although the difference lies in how it tells the body to recognize the protein. Scientists grow a harmless version of the protein in cells and then purify it, before it is assembled into a vaccine and injected.

China has been slow in vaccinating its population of 1.4 billion people, despite having four vaccines approved for general use. The latest numbers, according to government officials at a press briefing Monday in Beijing, is that it has administered 64.98 million doses of vaccines.

China has targeted what it considers key populations for vaccination thus far, namely health care workers, those who work at the border or customs, and specific industries the government has selected. Other groups that have been notably absent thus far in comparison to many other countries are the elderly and those with pre-existing conditions.

The approved vaccines have previously been limited to adults 18-59 years old, as officials cited a lack of clinical trial data for those who are older, although the government appears to be signaling the limits are now being set aside.

"We will promptly carry out mass vaccination of relevant populations," Li Bin, a vice chair on the National Health Commission, said Monday.

China's official Xinhua News Agency reported over the weekend that in certain neighborhoods in Beijing, local health centers started to offer the vaccines to those aged 60 and older.

https://medicalxpress.com/news/2021-03-china-fourth-covid-vaccine-emergency.html

Covid-19 variant tests emerge – but only for research

 By sheer luck, Thermo Fisher Scientific and Applied DNA Sciences have found themselves with Covid-19 tests capable of differentiating the UK variant of the coronavirus. Now diagnostics groups are deliberately developing tests that can do this and more. Today Roche began selling the cobas Sars-Cov-2 Variant Set 1 test, capable of pinpointing infections with the UK, South Africa and Brazil strains. The molecular test detects mutations in the gene for the virus’s spike protein, and runs on Roche’s widely used cobas 6800 and 8800 high-throughput machines. The South Korean group Seegene got there first, however. In early March it said it had developed the world’s first variant diagnostic test, the Allplex Sars-Cov-2 Master assay, which can identify the same three strains, and detects two additional mutations. Neither test is authorised by the US FDA, and thus neither can be used by US healthcare professionals to diagnose patients. Roche’s assay remains research use only for now; under that designation scientists can use it to track mutation prevalence and assess potential impact on diagnostics, vaccines and therapeutics. The Swiss group declined to tell Evaluate Vantage whether it would seek emergency use authorisation for its test.

Detecting the variants: Roche and Seegene
Spike gene mutationVariant in which mutation foundEffect of mutationDetected by Roche test? Detected by Seegene test? 
del
69-70
B117 (UK)Might help virus evade some antibodies; associated with increased transmissibilityYY
N501YB117 (UK), B1351 (South Africa), P1 (Brazil)Helps virus latch on more tightly to human cells; associated with increased transmissibilityYY
E484KP1 (Brazil)Might help virus evade some antibodies; possibly diminishes vaccine efficacyYY
P681HB117 (UK)Might help infected cells create new spike proteins more efficientlyNY
K417TP1 (Brazil)Might help virus latch on more tightly to human cellsNY
Source: company releases & published research.

https://www.evaluate.com/vantage/articles/news/snippets/covid-19-variant-tests-emerge-only-research

Cyclo Therapeutics Business Update and 2020 Results

 - Multiple value-driving milestones expected throughout 2021

- Trappsol® Cyclo™ Niemann Pick Disease Type C (NPC) clinical program on track to imminently report topline results from Phase 1/2 study

- Company expects to commence enrollment in pivotal Phase 3 study of Trappsol® Cyclo™ for NPC in Q2 2021

- IND filing for Trappsol® Cyclo™ Alzheimer’s Disease program on track for H2 2021

- Strengthened balance sheet with exercise of warrants


https://www.businesswire.com/news/home/20210315005155/en/Cyclo-Therapeutics-Provides-Business-Update-and-Reports-Fourth-Quarter-and-Full-Year-2020-Financial-Results

JPMorgan interns will come into the office this summer as lockdowns ease

 JPMorgan expects thousands of summer interns in London and New York to come into the office this summer, as the world's largest investment banks look to get their training programmes back on track after shifting them online during the Covid-19 crisis.

The US bank is planning to bring in sales and trading and investment banking interns into its offices this year, according to people familiar with the matter, even as some rivals keep their training programmes virtual.

Goldman Sachs has also told its summer interns in February that bank bosses expect them to be in office when the programmes kick off in July, Financial News reported.

However, Wells Fargo will stick to the virtual format for summer analysts within its corporate and investment bank, and Morgan Stanley will start its training programme online.

While most investment banks have heralded the success of working from home during the Covid-19 pandemic, as both advisory and trading revenues have surged over the past 12 months, most executives have cited the need to get juniors back into the office for vital training and mentoring.


Summer internships are banks' main entry-level recruitment tool, with thousands of students from top universities brought in each year as a dress rehearsal for securing a full-time position. The places are highly-competitive, with Goldman Sachs receiving 100,000 applications for 3,000 graduate roles last year, and Morgan Stanley getting 34,000 applications for 470 summer internships in Europe, the Middle East and Africa.

As well as formal training, students are offered networking opportunities with senior bankers, get to shadow other juniors and have informal interactions with employees, all of which are difficult to replicate virtually.

In a presentation to staff last week, Goldman Sachs chief executive David Solomon said that the bank's intake of summer interns and full-time analysts need to come into the office and be supported by other employees.


“Getting them in to the office is the best way to get them connected to Goldman Sachs,” he said.

JPMorgan chief executive, Jamie Dimon, has also spoken about the need to get junior employees back to the office. “There are a lot of people who have been hired into our companies who have never been into our company,” he told a conference in October. “How do you build a culture and character? How are you going to learn properly?”

The analyst class of 2020 has yet to see the office and investment banks have been pulling out the stops to keep them engaged, as many have considered quitting the industry. JPMorgan has offered its new juniors virtual boxing lessons and 'escape room' games, while Citigroup and Goldman Sachs have both started schemes to allow analysts access to senior investment bankers.

https://www.fnlondon.com/articles/jpmorgan-interns-will-come-into-the-office-this-summer-as-lockdowns-ease-20210316

Pfizer sees ‘opportunity’ to hike price for COVID-19 vaccine: CFO

Pfizer is looking to turn its lucrative coronavirus vaccine into an even bigger cash cow.

The drugmaker sees a “significant opportunity” to charge more for the groundbreaking shot once it gets to the other side of the COVID-19 pandemic, one top executive says.

Pfizer set the current prices for the vaccine it developed with its German partner, BioNTech, based on the need for governments to secure doses and get the virus under control, according to chief financial officer Frank D’Amelio.

For instance, Pfizer is charging the US government $19.50 per dose — well below the $150 or $175 per dose it typically pulls in for a vaccine, D’Amelio said on the company’s February earnings call.

But “normal market conditions will start to kick in” as the global pandemic shifts into an endemic, D’Amelio said last week.

He suggested that those less-urgent conditions could play to Pfizer’s advantage given that its shot is 95 percent effective, the highest rate among the three vaccines currently cleared for use in the US.

“Factors like efficacy, booster ability, clinical utility will basically become very important, and we view that as, quite frankly, a significant opportunity for our vaccine from a demand perspective, from a pricing perspective, given the clinical profile of our vaccine,” D’Amelio said Thursday during the Barclays Global Healthcare Conference.

The Manhattan-based pharma giant already expects to rake in about $15 billion in sales this year from the two-dose COVID vaccine with a profit margin of more than 20 percent of the shot’s total revenues.

Those profits could get even larger once Pfizer gets out of the “pandemic-pricing environment,” D’Amelio told investors last month.

“Obviously, we’re going to get more on price,” he said on Pfizer’s earnings call. “And clearly … the more volume we put through our factories, the lower unit cost will become.”

Pfizer also thinks it’s “becoming increasingly likely” that people will need an annual booster shot to ward off the COVID-19 variants that have emerged around the world, according to D’Amelio.

Pfizer has launched a study of a third vaccine dose to address the variants.

“We don’t see this as a onetime event, but we see this as something that’s going to continue for the foreseeable future,” D’Amelio said.

https://nypost.com/2021/03/16/pfizer-sees-opportunity-to-hike-price-for-covid-vaccine/


Employers with large on-site workforce can set up COVID-19 vaccine clinics: CDC

 U.S. employers with a large workforce and locations that have enough space to maintain social distancing can consider setting up temporary vaccination clinics at the workplace, the Centers for Disease Control and Prevention (CDC) said on Tuesday.

The initial supply of COVID-19 vaccines is currently recommended for healthcare workers and long-term care facility residents, with frontline essential workers and people 75 years and older next in line to receive a vaccine.

Employers with a sizeable workforce on site, predictable schedules and ability to sign up as a vaccination provider should consider mobile or temporary vaccine clinics, the CDC said. 

While vaccine supply is currently limited, the CDC said its recommendations could help employers prepare for vaccinations either at the workplace or when the vaccine becomes available in the community.

https://www.reuters.com/article/us-health-coronavirus-cdc-workplace/employers-with-large-on-site-workforce-can-set-up-covid-19-vaccine-clinics-u-s-cdc-idUSKBN2B82AH

Austria's Kurz and allies seek 'correction' on EU vaccine distribution

 Austrian Chancellor Sebastian Kurz said on Tuesday he and allies from eastern Europe were pushing for the European Union to adjust the way it distributes COVID-19 vaccines after complaining it was uneven

Kurz and the leaders of Bulgaria, the Czech Republic, Slovenia, Latvia and Croatia last week wrote to the heads of the European Commission and Council, saying the distribution was not happening in line with national populations as had been agreed.

Kurz’s opponents have accused him of trying to deflect blame away from his government for the relatively slow pace of vaccinations.

The EU has a mechanism for redistributing doses left when others do not take up their full pro rata allocation, and the Commission has said it is up to member states to decide whether they want to go back to a strictly population-based method.

“It has to be possible here to develop a correction mechanism,” Kurz told a news conference with his Bulgarian, Czech and Slovenian counterparts after a meeting that the leaders of Croatia and Latvia joined by video link.

European Commission President Ursula von der Leyen and European Council President Charles Michel are working “to find a solution”, Kurz added.

Bulgaria and Latvia have administered a first vaccine dose to the smallest share of their adult populations in the EU, according to the latest weekly report here by the European Centre for Disease Prevention and Control, at 4.1% each.

In Malta that figure is 14.9%. Austria is on 7.8%.

https://www.reuters.com/article/us-health-coronavirus-eu-austria/austrias-kurz-and-allies-seek-correction-on-eu-vaccine-distribution-idUSKBN2B820S