The coronavirus outbreak is aggravating in many parts of the United States, compellin several states to pause their reopening plans. The state of Florida for instance reported 15,299 positive cases on Jul 12, a new record for a U.S. state. And with the spike in cases, an increasing number of hospitals are getting overburdened.
Meanwhile, two of four experimental coronavirus vaccines, manufactured jointly by Pfizer Inc
. (PFE - Free Report
) and BioNTech SE
(BNTX - Free Report
) , received fast track status from the FDA on Jul 13. The candidates, BNT162b1 and BNT162b2, are being evaluated in Phase 1/2 clinical studies in the United States and Germany. Notably, BNT162b1 showed positive results on humans in the United States in early July, while results from the German trial of BNT162b2 are expected to be released this month.
If the ongoing trials prove successful, the companies said that they will be able to jointly develop up to 100 million doses by the end of the year, and most likely more than 1.2 billion doses by the end of next year. Lest we forget, the FDA’s fast track process is designed to increase the pace of development and review of drugs that have the potential to treat serious conditions.
Meanwhile, Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer said that “the FDA's decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2.”
No doubt, the fast track designation bodes well for Pfizer, whose shares had fallen 13.7% year to date (till Jul 10). Shares of Pfizer, by the way, jumped 4.1% on Jul 13. Similarly, BioNTech’s shares soared 10.6% yesterday. What’s more, shares of both the companies are further expected to advance in the near term since both are likely to begin another large trial of up to 30,000 participants later this month, subject to regulatory approval. And Pfizer, in particular, expects continued strong growth of key brands like Ibrance, Inlyta and Eliquis to drive sales in 2020.
Other biotech stocks, tied to a coronavirus vaccine development program, have been surging lately. In fact, shares of Moderna, Inc
. (MRNA - Free Report
) and Novavax, Inc
. (NVAX - Free Report
) have skyrocketed 202% and 2521.1% year to date, respectively, as investors remain optimistic about the biotech firms’ coronavirus vaccine programs.
Even though Moderna started to venture into vaccine development business, it has been a pro in raising capital. The company drew attention after it received funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a messenger RNA (mRNA) vaccine to fight the novel coronavirus. Moderna has collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) to develop the experimental mRNA vaccine.
Moderna started injecting patients with its SARS-CoV-2 vaccine candidate, mRNA-1273, in a phase 2 clinical trial in May. The company’s manufacturing unit is also aiming to improve production capacity so that it can produce “millions of doses,” provided the vaccine is safe and effective.
And when it comes to American biotech company Novavax, it began its first human study of its experimental coronavirus vaccine on May 25, and expects preliminary results from the trial this month. In its Phase 1 clinical trial, Novavax’s coronavirus vaccine candidate NVX-CoV2373 that includes Matrix-M adjuvant has been helpful in boosting immune responses.
Once the Phase 1 trial is successful, Novavax said that the Phase 2 trial will begin in many countries, including the United States, and will assess immunity, safety as well as focus on COVID-19 disease reduction among a broader age range.
To top it, Novavax recently received $1.6 billion from the U.S. government to conduct advance human studies and develop 100 million dozes of vaccine by this year. The fund will help the company study its vaccine candidate on at least 30,000 subjects, as early as fall. Novavax, in fact, received as much as $388 million in May from CEPI, the single largest contributor for the organization at that time.
Johnson & Johnson
(JNJ - Free Report
) is also among the front runners to develop a coronavirus vaccine. Its stock hit a low on March 2020 but quickly recovered in less than a month on bullish expectations for its COVID-19 vaccine.
Chief Executive Alex Gorsky admitted that he sees a “high degree of probability of being successful.” He categorically said that the company could have a coronavirus drug available in the first or second quarter of 2021. The company is aiming to have 1 billion dozes available by the end of next year.
The company, in itself, is doing good. Its sales of immunology, oncology and neuroscience drugs grew in the first quarter. J&J is making rapid progress with its pipeline and line extensions. And several pivotal data readouts and regulatory milestones are expected in 2020.
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