Pfizer vaccine very effective against Delta variant in adolescents in Israel

 The Pfizer/BioNTech COVID-19 vaccine is highly effective at preventing infection and symptomatic disease from the Delta variant among 12- to 18-year-olds, research conducted in Israel shows.

The findings, published in the New England Journal of Medicine, will likely provide further reassurance the shot is effective against the variant among younger people as the U.S. drug watchdog considers authorising use of the vaccine on children as young as five.

The study found the estimated vaccine effectiveness against documented COVID-19 infection in adolescents was 90%, and 93% against symptomatic COVID-19, on days seven to 21 after the second dose.

Israel's Clalit health maintenance organisation and Harvard University researchers reviewed data from 94,354 vaccine recipients aged 12 to 18 who were matched with an identical number of unvaccinated adolescents from the same age group.

The research was conducted between June and September, when the Delta variant was the main strain in Israel.

In a statement late on Wednesday, Clalit said the study was one of the largest peer-reviewed evaluations conducted among the age group of the effectiveness of the vaccine against the Delta variant.

Earlier this week, an analysis released by the U.S. Centers for Disease Control and Prevention (CDC) showed the Pfizer Inc /BioNTech vaccine was 93% effective in preventing hospitalisations among those aged 12 to 18.

The Pfizer/BioNTech vaccine is authorised for children as young as 12, and the companies are seeking further approval from the U.S. Food and Drug Administration for use in those as young as five.

A panel of advisers to the FDA is expected to weigh in on data on young children later this month.

In England, the spread of COVID-19 among children is fuelling a rise in cases and causing concern among some scientists that vaccines are being rolled out in schools too slowly.

https://finance.yahoo.com/news/pfizer-vaccine-very-effective-against-081632035.html

Quest Diagnostics boosts forecasts on strong COVID-19 test demand

 Quest Diagnostics Inc on Thursday raised its annual revenue and profit forecasts after it beat estimates for quarterly results, on strong demand for its COVID-19 tests due to the spread of the virulent Delta variant in the United States.

Shares of the U.S. laboratory rose about 4% before the bell.

COVID-19 testing volumes in the U.S. had slumped in the first half of this year, but demand rose once again in recent months due to the Delta variant, leading employers and schools to implement strict screening programs.

Diagnostic companies like Abbott Laboratories have said demand for COVID-19 tests rebounded during the quarter.

The country witnessed a swift rise in the number of COVID-19 cases since July, reaching a peak of more than 190,000 new cases daily in early September, according to data from the Centers for Disease Control and Prevention.

In September, President Joe Biden announced policies requiring large employers to have their workers inoculated or tested weekly.

However, Quest said in late summer it saw some softness in its base business across the country, but saw an overall rebound in September.

"Our base business continued to improve sequentially in the third quarter which speaks to the ongoing recovery," said Chief Executive Officer Steve Rusckowski.

The company raised its full-year profit outlook to $13.50 to $13.90, from $11.65 to $12.35. Analysts on an average estimate $11.93.

Excluding items, Quest earned $3.96 per share for the third quarter ended Sept. 30, beating analysts' estimates of $2.88, according to Refinitiv data.

Revenue fell to $2.77 billion from $2.79 billion, but came ahead of analysts' estimate of $2.45 billion. 

https://finance.yahoo.com/news/1-quest-diagnostics-raises-full-110734330.html

Merck backed by CDC panel on pneumococcal vaccine

 Series Would be Routinely Recommended Both for Adults 65 Years and Older and for Adults Ages 19 to 64 at Increased Risk for Disease, Such as Those with Certain Underlying Medical Conditions

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older, and for adults ages 19 to 64 with certain underlying medical conditions (e.g., chronic conditions such as diabetes, chronic heart disease, chronic lung disease, or chronic liver disease, as well as HIV, an immunocompromising condition) or other disease risk factors (e.g., smoking, alcoholism). In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23, or with a single dose of 20-valent pneumococcal conjugate vaccine. These updates would apply to adults who have not previously received a pneumococcal conjugate vaccine or whose previous pneumococcal vaccination history is unknown.

Further details will be available from the CDC. These provisional recommendations will be reviewed by the director of the CDC and the Department of Health and Human Services, and final recommendations will become official when published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

https://finance.yahoo.com/news/cdc-acip-unanimously-votes-provisionally-230700276.html

Moderna upped to Overweight from Neutral by Piper Sandler

 Target $445

https://finviz.com/quote.ashx?t=mrna

Japan's Shionogi starts Phase II/III clinical trial for new COVID-19 vaccine

 Japan' Shionogi & Co Ltd 4507.T said on Wednesday it had started a Phase II/III clinical trial for its COVID-19 vaccine candidate.

The trial for the recombinant protein-based vaccine will take place in Japan and follows a Phase I trial in the country, Shionogi said in a statement. The company will also prepare to conduct multiple trials globally, it said.

Medicines usually have to pass three phases of clinical trials before they can be assessed for approval by regulators.

Separately, Daiichi Sankyo Co 4568.T said it planned to start a Phase II trial for its COVID-19 vaccine candidate next month.

The Japanese drugmaker is aiming for commercialization of the mRNA-type vaccine, known as DS-5670, in 2022, it said in a statement.

https://www.nasdaq.com/articles/japans-shionogi-starts-phase-ii-iii-clinical-trial-for-new-covid-19-vaccine-2021-10-21

Ventyx Biosciences (VTYX) IPO: 8 Things to Know

 Ventyx Biosciences (NASDAQ: VTYX), a biotech company that is developing selective therapies for inflammatory and autoimmune diseases, is due to go public this week. Here are 8 key things to consider about the upcoming Ventyx Biosciences IPO.

1. Ventyx Biosciences IPO Date - Ventyx Biosciences is scheduled to go public this Thursday, October 21. Ventyx Biosciences will start trading under the ticker symbol “VTYX” on Nasdaq. Typically, shares that make their public stock market debuts start trading between 10 AM - 2 PM ET.

2. Ventyx Biosciences IPO Price - Ventyx Biosciences expects to price its shares between $15.00 and $17.00.

3. Ventyx Biosciences IPO Shares Offered - Ventyx Biosciences is looking to sell 7,812,500 of its common stock. The S-1 filing shows the number of outstanding shares after IPO offering would be 47,270,263 shares.

4. Ventyx Biosciences IPO Valuation - Ventyx Biosciences is seeking a valuation of between $709 million and $803.5 million.

5. VTYX IPO Raised Proceeds: At the midpoint of the pricing range, Ventyx Biosciences is looking to raise $125 million.

6. VTYX IPO Underwriters - Jefferies, Evercore ISI, Piper Sandler, and LifeSci Capital are underwriters for this IPO.

7. VTYX Financials - As of June 30, 2021, the company had an accumulated deficit of $87.3 million. For the six months ended June 30, 2021, Ventyx Biosciences incurred a net loss of $53.2 million.

8. Drug Pipeline: VTX958, an oral, selective clinical-stage tyrosine kinase type 2 (TYK2) inhibitor, VTX002, an oral, selective Phase 2-ready sphingosine 1 phosphate receptor 1 (S1P1R) modulator for ulcerative colitis (UC). Also developing a comprehensive portfolio of differentiated NOD-like receptor protein 3 (NLRP3) inhibitors to address multiple indications driven by NLRP3 inflammasome activation.

https://www.streetinsider.com/IPOs/Ventyx+Biosciences+%28VTYX%29+IPO%3A+8+Things+to+Know/19071423.html

Novartis in New Agreement With BioNTech to Help Manufacture Covid-19 Vaccine

 Novartis AG said Thursday that it has signed a new agreement with BioNTech SE to support the production of the company's and Pfizer Inc.'s Covid-19 vaccine at one of its facilities.

The Swiss pharma major said it will support the fill-and-finish operations of the vaccine, meaning the transfer of the vaccine substance into vials under sterile conditions.

It will do so at its facility in Ljubljana, Slovenia, and will begin operations in the first half of 2022, Novartis said. At least 24 million vaccine doses will be filled there, the company said.

The agreement follows another one which was signed earlier this year and which had Novartis filling and finishing more than 50 million doses at its site in Stein, Switzerland.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-in-New-Agreement-With-BioNTech-to-Help-Manufacture-Covid-19-Vaccine-36736817/