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COVID Vaccine Update as Johnson & Johnson Trial Suffers Setback, Sanofi Aims for Mid-2021 Rollout

There are currently nearly 200 potential COVID-19 vaccine candidates in development, including 42 under clinical evaluation and 151 under pre-clinical evaluation, according to a report by the World Health Organization published on October 2.



a person wearing a costume: A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi's laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.


© Joel Saget/AFP via Getty Images
A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi’s laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.

On Monday, U.S.-based Johnson & Johnson announced a pause on all of its COVID-19 vaccine candidate clinical trials due to an “unexplained illness” in one of its study participants.

French pharmaceutical company Sanofi is hoping to have its vaccine candidate rolled out by mid-next year, according to Olivier Bogillot, its chief executive officer.

“We are in a very concrete environment at the regulatory level. We ourselves have signed a charter with various laboratories so as not to compromise on the safety of the vaccine. If the vaccine is effective and it is safe, yes, the next year, in mid-year, the French will be able to be vaccinated,” Bogillot said Tuesday.

Last week, U.S. Secretary of Health and Human Services Alex Azar said: “Pending FDA [Food and Drug Administration] authorizations, we believe we may have up to 100 million doses by the end of the year—enough to cover especially vulnerable populations—and we project having enough for every American who wants a vaccine by March to April 2021.”

The First Phase 3 Clinical Trial Of A Coronavirus Vaccine In The US Has Begun

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Here we take a closer look at some of the latest COVID-19 vaccine developments.

France

Last month, Sanofi and U.K.-based GlaxoSmithKline (GSK) announced they has begun a clinical trial of their COVID-19 vaccine candidate, aiming to reach a phase-three trial by December.

“The companies initiated a Phase 1/2 study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year,” Sanofi confirmed in a statement last month.

“If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.”

U.S.

Johnson & Johnson

Johnson & Johnson, whose vaccine candidate JNJ-78436735 is being developed by Belgium’s Janssen Pharmaceutical Companies, announced: “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.

“Adverse events—illnesses, accidents, etc.—even those that are

Jeffries Says Sanofi Is ‘Most Compelling’ European Pharma Stock

– By Barry Cohen

Here’s a switch: Analysts are predicting sales for a Sanofi (NASDAQ:SNY) blockbuster drug that exceeds the company’s forecast.

Jefferies analysts wrote Dupixent revenue is likely to peak at $12.5 billion, according to an article in FiercePharma. That’s about 8% higher than Sanofi CEO Paul Hudson has set for the medication.

Dupixent is the first biologic medication approved by the Food and Drug Administration for adults and children aged six years and up with moderate to severe atopic dermatitis for whom topical treatments have not worked or are not advised.

Atopic is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States, according to the National Eczema Association. It’s a chronic condition that can come and go for years or throughout life and can overlap with other types of eczema. The condition triggers inflammation that damages the skin barrier, leaving it dry and prone to itching and rashes.

As of the second quarter, Dupixent sales have been running at about $1 billion every three months. Jeffries thinks that number could double by 2028 as the patient population for atopic dermatitis expands and the drug makes inroads into treatment for asthma and several additional indications.

Other companies have eczema drugs in testing, but it appears they will present little challenge to Dupixent because of their side effects. One is abrocitinib from Pfizer Inc. (NYSE:PFE), the other is Rinvoq from AbbVie Inc.(NYSE:ABBV).

Jeffries Says Sanofi Is 'Most Compelling' European Pharma Stock
Jeffries Says Sanofi Is ‘Most Compelling’ European Pharma Stock

In addition to making Dupixent Sanofi’s key growth driver, Hudson, a year into his tenure at the company’s helm, has launched a program to cut about $2.5 billion in costs by 2022. He’s also focusing the company’s research and development so it yields drugs that are “first-in-class” or “best-in-class.” To supplement in-house research, Sanofi has been busy scouting for outside help. It recently closed a $3.7 billion acquisition of Principia Biopharma. According to the terms of the deal, the Paris-based company gets drugs to treat conditions such as multiple sclerosis, immunological and inflammatory diseases.

Jeffries analysts acknowledge Sanofi is much more than Dupixent, pointing to the company’s flu vaccines, robust pipeline and cost-cutting initiatives. In a bit of high praise, Jeffries said that from an investment perspective, Sanofi is the “most compelling” among large European pharma companies.

Sanofi is also engaged in the fight against Covid-19. The company recently began a phase 1/2 clinical trial of the vaccine it is developing in conjunction with GlaxoSmithKline (NYSE:GSK). The company said it anticipates results will be available in December, and if the shot passes muster, Sanofi could ask for regulatory approval in the first half of 2021.

Sanofi currently trades just below $50, It’s year-to-date range is $37.62 to $55. Its dividend yields nearly 3.4%. According to CNN Money, the 19 analysts offering 12-month price forecasts have a median target of $62.62, with a high estimate of $68.99 and a low estimate of $50.27. They rate Sanofi