The Advantage Johnson & Johnson’s Phase 3 COVID-19 Study Has Over Rivals
The race for the COVID-19 vaccine is still very much in the running. Perhaps more than one company ends up being deemed a winner. Which company is first to market with a vaccine depends on many issues, the first of which is an approval from the U.S. Food and Drug Administration. Four groups are in late stage-trials for a coronavirus vaccine that is greatly needed to allow a return to normalcy.
Johnson & Johnson (NYSE: JNJ) has announced that it has entered late-stage trials for its JNJ-78436735 COVID-19 vaccine candidate. The Phase 3 study is for a single-dose treatment, although its efforts are not the same as rivals. The company has said that this Phase 3 study will have 60,000 participants around the globe.
Its COVID-19 candidate is said not require the same freezing temperatures for storage, as its adenovirus vector technology has shown to be stable even at room temperature. It is in collaboration with the National Institute of Allergy and Infectious Diseases, and it is using the AdVac platform that has been used to vaccinate more than 100,000 people to date. This same platform was used to make its Ebola vaccine and construct its Zika, RSV and HIV vaccine candidates.
The company announced that its Phase 1/2a clinical study demonstrated safety and immunogenicity after a single vaccination. The study results were also submitted to medRxiv, and those results are to be published online imminently. Johnson & Johnson also added that it has been scaling up manufacturing capacity and that it remains on track to provide a billion doses of a vaccine per year.
The company also said the vaccine is expected to be affordable for the public and is being done on a not-for-profit basis for emergency pandemic use. If the safety and efficacy go as it expects, and if it receives FDA approval, Johnson & Johnson expects that JNJ-78436735 can see the first doses available for emergency use authorization in early 2021.
Moderna Inc. (NASDAQ: MRNA) is considered to be in a leadership position with its Phase 3 study now, and the company just received an upgrade to 20 million units pre-ordered in Canada this week. Moderna recently has downplayed some of the timing issues in the race for a vaccine, noting that being the best is better than being the first to market.
Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX) were in the news recently after the BioNTech CEO suggested that their vaccine was “nearly perfect” in an interview, but that was not a formal clinical update.
Novavax Inc. (NASDAQ: NVAX) stock has been the biggest winner of the lot so far, with shares rising more than 20-fold in 2020. Its market cap is now $6.6 billion, and it will have more than 60,000 participants globally. The news helped to boost markets in premarket action. That said, it has been expanding its capabilities with the hopes of getting 2 billion doses ready in 2021.
While two U.S. vaccine frontrunners are using mRNA technology, Johnson & Johnson’s potential vaccine has been said to look more like that of AstraZeneca PLC (NYSE: AZN). The AstraZeneca trial was halted based on an unexplained illness with one participant in the United Kingdom, but the company has resumed its Phase 3 trials there after determining the issue likely was not related to the trial. The United States is still investigating the cause.
Nine biotech and pharmaceutical CEOs signed a pledge earlier in September to focus on safety and well-being ahead of racing just to get a COVID-19 vaccine out first. Their unanimous commitment is to develop and test COVID-19 vaccine candidates “in accordance with high ethical standards and sound scientific principles.” In short, science over politics and social pressure.
The FDA also has pledged that it will not rush an unproven vaccine to market. The agency already said publicly that any COVID-19 vaccine approval requires scientific evidence of safety and efficacy from a randomized and observer-blinded study that includes a significant number of participants across diverse populations.
Johnson & Johnson stock traded up over 1% at $145.90 a share on Wednesday morning. Moderna stock was down 3.7% at $66.27, and Novavax stock was down more than 4.7% at $106.24. Pfizer stock was holding up better, with a mere two-cent loss to $36.23 a share, but its partner BioNTech saw a 3.4% drop to $64.70.
AstraZeneca stock was actually up 1.3% at $56.15 in New York trading on Wednesday morning.
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