The COVID-19 vaccine development programs of companies like Pfizer PFE/BioNTech BNTX and Moderna have progressed at a rapid pace.
Pfizer/BioNTech mRNA-based coronavirus vaccine candidate, BNT162b2 was granted emergency use by the FDA on Dec 11. The approval for BNT162b2 comes in less than a year since the companies started developing it, which is probably the fastest in the history of vaccines.
BNT162b2 is now approved for emergency use in the United States, United Kingdom, Bahrain, Mexico, Singapore and Canada and most like will get a green signal in European Union next week.
Moderna has also applied for emergency use in the United States and EU for its coronavirus vaccine candidate, mRNA-1273. It uses the same mRNA-based technology as Pfizer/BioNTech. An FDA committee recommended approval of Moderna’s vaccine on Dec 17. We expect that the FDA will approve Moderna’s vaccine by next week.
Pfizer and Moderna’s vaccines proved 95% and 94.1% effective, respectively, in preventing COVID-19 in phase III clinical studies
Other than Pfizer/BioNTech and Moderna, AstraZeneca/Oxford University and J&J are the lead players in the COVID-19 vaccine development race. While AstraZeneca/Oxford University have begun regulatory submissions for their COVID-19 vaccine candidate, AZD1222, J&J’s COVID-19 vaccine candidate, JNJ-78436735 is being evaluated in the ENSEMBLE phase III study. Both AstraZeneca and J&J should be able to launch their vaccines in the first quarter of next year, if approved.
No doubt Pfizer and Moderna have taken a lead in the in the race to launch a vaccine to help bring an end to this devastating pandemic However, multiple vaccines will be needed to inoculate the world’s population. There are a few small biotech companies, which are also developing vaccines for COVID-19 and should be able to launch their products next year. If their vaccines prove effective in clinical studies and are eventually approved, they will rake in huge profits. Here we discuss four such companies
Novavax’ pivotal phase III study on its COVID-19 vaccine candidate, NVX-CoV2373, in the United States and Mexico is expected to begin in the coming weeks. Meanwhile, a phase III study on NVX-CoV2373 in the United Kingdom and the phase IIb efficacy study in South Africa have completed full enrollment with more than 20,000 participants dosed in these studies. Interim data from the U.K. study is expected in the first quarter of 2020.
Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including more than $1.6 billion from the U.S. government’s Operation Warp Speed program.
The candidate demonstrated strong antibody data in phase I and it is quite likely that the efficacy and safety data from the phase II/III studies will be positive. Novavax is positioned to become a key player in the COVID-19 vaccine space.
The stock has risen 3211.1% this year so far compared with 8.4% increase for the industry.
Vaxart is developing an oral vaccine for COVID-19 in a phase I study that can be administered by tablet rather than by injection.
The oral tablet COVID-19 vaccine candidate, VXA-CoV2-1, may offer enormous logistical advantages as it can be conveniently distributed and administered without the need for cold-chain storage and distribution. Pre-clinical data on the tablet vaccine has indicated that VXA-CoV2-1 activates both systemic and mucosal immunity, a broader immune response compared to injectable vaccines.
The stock is up 2068.3% this year compared with 1.6% increase for the industry.
Arcturus Therapeutics Holdings ARCT
Arcturus is developing a self-replicating mRNA based COVID-19 vaccine, ARCT-021, which the company claims may have differentiated clinical profile and may allow vaccination at low doses. The potential single shot vaccine, if approved, should allow successful execution of massive global vaccination campaigns to control the COVID-19 pandemic.
Initial phase I/II data on the candidate demonstrated favorable immunogenicity and safety results for both single-dose and prime-boost regimens. Additional data from the study is expected in the near term. Later-stage clinical trials are expected to begin soon.
Its stock is up 852.0% this year so far, compared with the industry’s increase of 8.4%.
CureVac N.V. CVAC
CureVac dosed the first participant in its global pivotal phase IIb/III study — HERALD — evaluating its mRNA-based COVID-19 vaccine candidate, CVnCoV. The study will include almost 35,000 participants, primarily from Europe and Latin America. Interim data from the phase I study, announced last month, were positive, which demonstrated that the candidate induced strong antibody responses and the immune response was comparable to naturally recovered COVID-19 patients.
Meanwhile, CVnCoV remains stable at a standard refrigerator temperature (5°C) for at least three months and for up to 24 hours at room temperature as ready-to-use vaccine. Its storage needs are thus less stringent than Pfizer/BioNTech and Moderna’s, which could give it a distributional advantage over these vaccines, if its product is successfully developed and approved. CureVac is building a strong European manufacturing network to supply up to 300 million doses by the end of 2021 and up to 600 million doses in 2022, primarily in Europe.
Its stock is up 99.0% since it started trading on Aug 4 compared with the industry’s increase of 8.4%.
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