Biotech firms and drugmakers across the globe are pumping in billions of dollars to develop a vaccine as the only resort to wipe out the deadly coronavirus but there is no sign of it yet.
However, a few companies have made substantial progress in the race to develop a vaccine. On July 27, Moderna, Inc. (MRNA) launched the phase 3 trial of its vaccine candidate on thousands of volunteers. Separately, Pfizer, Inc. (PFE) also advanced into its final-stage trials. This has once again raised hopes of a COVID-19 vaccine by the end of this year, which even some drugmakers consider possible.
Vaccine Hopes Rise Again
Moderna and Pfizer launched two 30,000-subject trials of COVID-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, the companies said on Jul 27. The trials, both announced on Monday, are the first late-stage studies supported by the Trump administration’s effort to ramp up development of a coronavirus vaccine.
Moderna’s randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Moderna is working closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the phase 3 COVE study under the auspices of Operation Warp Speed.
The Pfizer vaccine study is being conducted in the United States and elsewhere. Like Moderna, Pfizer also aims to recruit 30,000 volunteers for the trial. Pfizer already has an agreement to sell 100 million doses of its vaccine to the U.S. government and give it the option to buy 500 million more.
Vaccine Race Heats Up
Although treatment for COVID-19 is yet to be found, a large number of drugmakers and biotech companies have made remarkable progress in developing a vaccine over the past couple of months. Also, some have started ramping up production of their vaccine candidates, anticipating huge demand if they prove successful.
Earlier this month, Dr. Anthony Fauci, United States’ leading infectious diseases doctor, said on Jul 6 that the nation will get to know by the end of this year whether a coronavirus vaccine is safe and effective. He had also assured that a vaccine will be available as soon as the clinical trials are complete, giving a boost to the confidence of millions.
Stocks in Focus
Moderna has been one of the frontrunners in the COVID-19 vaccine race. The company’s vaccine candidate mRNA-1273 is a molecule that genetically encodes a set of instructions based on which cells make proteins and send them to various parts of the body. Moderna’s vaccine for COVID-19 showed it was safe and triggered immune responses in all 45 healthy volunteers in the early-stage study. Its shares have gained 30.4% in the past 30 days. Moderna has a Zacks Rank #2 (Buy).
Pfizer joined forces with German biotech giant BioNTech (BNTX) to develop a vaccine for coronavirus. The 360 patients in the United States trial started to receive the first doses of the four vaccine candidates included in the study as of May 5. Dosing in 200 participants in the German trial began on Apr 23. The company has now entered its phase 2/3 safety and efficacy clinical study on 30,000 subjects. The candidate so far has shown promise and the U.S. government has also placed an initial order of 100 million doses for $1.95 billion to secure 500 million additional doses of the vaccine. Pfizer’s shares have advanced 17.2% in the past month. The Zacks Consensus Estimate for current-year earnings has improved 0.7% over the past 60 days. Pfizer carries a Zacks Rank #3 (Hold).
Gilead Sciences, Inc. (GILD) in May received an emergency-use authorization from the FDA based on preliminary results from two clinical trials: one conducted by the NIAID and the other by Gilead. The company’s expected earnings growth rate for next year is 4.2%. The Zacks Consensus Estimate for current-year earnings has improved 3.9% over the past 30 days. Shares of the company have gained 14.7% year to date. Gilead has a Zacks Rank #3.
Amgen, Inc. (AMGN) , one of the biggest biotech companies in the world, collaborated with Adaptive, Inc. (ADPT) in April to work on antibodies that can be used to prevent or treat COVID-19. Amgen also plans to test Otezla as a COVID-19 therapy treating respiratory distress in late-stage patients in the coming days.
Amgen’s expected earnings growth rate for the current year is 5.2%. The Zacks Consensus Estimate for current-year earnings has improved 0.2% over the past 60 days.
Dynavax Technologies Corporation (DVAX) is developing a vaccine candidate SCB-2019 with GlaxoSmithKline plc (GSK) which is in its phase 1 clinical trials. The vaccine is made up of S-Trimer protein that resembles the coronavirus spike protein and hence triggers the immune system to produce antibodies. Last week, Dynavax partnered with Taiwan-based Medigen Vaccine Biologics to develop an adjuvanted Covid-19 vaccine candidate.
The partners will leverage Medigen’s stable prefusion form of the SARS-CoV2 recombinant spike protein in combination with Dynavax’s advanced adjuvant CpG 1018.Dynavax’sshares have rallied 140.1% in the past three months. Dynavax has a Zacks Rank #3.