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COVID-19 Vaccine Race Heats Up as Pfizer Gets Emergency Nod
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In a not-so-surprising news, the FDA granted emergency use authorization (EUA) to Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2 on Dec 11. The FDA’s EUA approval came just a day after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4, recommending that the FDA grant the EUA. Vaccinations in the United States are expected to begin from Monday.
Pfizer and BioNTech have plans to file a biologics license application for possible full regulatory approval in 2021 as it gathers additional data from ongoing studies on BNT162b2.
The EUA was based on data from a phase III study, announced last month, which showed that BNT162b2, a two-shot vaccine, was 95% effective in preventing COVID-19 after two doses were given three weeks apart.
Pfizer/BioNTech had filed the EUA on Nov 20. BNT162b2 was approved for emergency use in United Kingdom and Bahrain earlier this month and in Canada last week. Meanwhile, the companies have also filed for emergency use in EU and India. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, and Japan.
Pfizer plans to manufacture up to 50 million doses by the end of this year and potentially up to 1.3 billion doses by the end of 2021. It has already signed advance supply agreement for vaccine doses with governments around the world.
Impact of EUA on Other Vaccine Makers
No doubt Pfizer has taken a lead in the in the race to launch a vaccine to help bring an end to this devastating pandemic. The fast-regulatory approvals for Pfizer’s vaccine raise hope that candidates of other lead COVID-19 vaccine developers may also get emergency approvals for their products rapidly, provided they prove their efficacy and safety in clinical studies. Multiple vaccines will be needed to inoculate the world’s population.
Other than Pfizer/BioNTech, Moderna (MRNA - Free Report) , AstraZeneca (AZN - Free Report) /Oxford University and J&J (JNJ - Free Report) are the lead players in the COVID-19 vaccine development race.
Though these companies will bring their vaccines later than Pfizer, their product may become more successful than Pfizer and they may not face any major trouble in gaining market share. Here’s why.
Moderna
Pfizer/BioNTech’s close competitor is Moderna, which 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. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis. An FDA committee is due to review Moderna’s vaccine on Dec 17. We expect that the FDA may immediately approve Moderna’s vaccine considering that it too has shown similar efficacy in late-stage studies.
This will make Moderna one of two early entrants in the COVID-19 vaccine space and it can reap in some early profits. Meanwhile, Moderna’s cold storage requirements are less stringent than Pfizer’s. Moderna’s vaccine can remain stable at standard refrigerator temperature (2°-8°C) for 30 days while Pfizer’s vaccine needs to be stored at extremely low temperatures (-70°C±10°C) for up to 15 days
AstraZeneca
Meanwhile, AstraZeneca/Oxford University’s potential COVID-19 vaccine candidate, AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies. AstraZeneca has begun submission of data to regulatory authorities around the world for early approval. If the necessary approvals are obtained, it may be able to launch its vaccine early next year.
In September, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, as a patient in U.K. suffered an unspecified illness. While studies in UK, Brazil, South Africa and Japan resumed in the weeks thereafter, following regulators’ confirmation, the study in the United States remained on hold for some time and resumed in late October. Though the temporary setback put AstraZeneca behind Pfizer and Moderna, the company is now back on track.
AstraZeneca’s vaccine is not a mRNA-based treatment like Pfizer and Moderna’s. It uses a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
AstraZeneca’s vaccine can be transported and stored at normal refrigerator temperatures (2°-8°C) for at least six months. AZD1222’s normal storage needs may give the company an advantage from logistics point of view as it makes it much easier to distribute globally using the normal immunization distribution system. Reportedly, AstraZeneca’s vaccine is also cheaper than others being priced at less than $3 a dose.
J&J
J&J’s COVID-19 vaccine candidate, JNJ-78436735 is being evaluated in the ENSEMBLE phase III study, which is expected to enroll 60,000 adult participants globally. The ENSEMBLE study was paused in October due to an unexplained illness observed in a study participant. The study was resumed later in the month as it was not clear whether the unexpected serious adversity was related to the vaccine shot.
J&J should report interim efficacy results for JNJ-78436735 early next year. If the data are positive and necessary regulatory approvals are received, J&J may launch its vaccine in the first quarter of 2021 and still have a large market share to capture. JNJ-78436735’s biggest advantage among the leading COVID-19 vaccines in that it requires only a single shot unlike those of Pfizer, AstraZeneca or Moderna.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
COVID-19 Vaccine Race Heats Up as Pfizer Gets Emergency Nod
In a not-so-surprising news, the FDA granted emergency use authorization (EUA) to Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2 on Dec 11. The FDA’s EUA approval came just a day after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4, recommending that the FDA grant the EUA. Vaccinations in the United States are expected to begin from Monday.
Pfizer and BioNTech have plans to file a biologics license application for possible full regulatory approval in 2021 as it gathers additional data from ongoing studies on BNT162b2.
The EUA was based on data from a phase III study, announced last month, which showed that BNT162b2, a two-shot vaccine, was 95% effective in preventing COVID-19 after two doses were given three weeks apart.
Pfizer/BioNTech had filed the EUA on Nov 20. BNT162b2 was approved for emergency use in United Kingdom and Bahrain earlier this month and in Canada last week. Meanwhile, the companies have also filed for emergency use in EU and India. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, and Japan.
Pfizer plans to manufacture up to 50 million doses by the end of this year and potentially up to 1.3 billion doses by the end of 2021. It has already signed advance supply agreement for vaccine doses with governments around the world.
Impact of EUA on Other Vaccine Makers
No doubt Pfizer has taken a lead in the in the race to launch a vaccine to help bring an end to this devastating pandemic. The fast-regulatory approvals for Pfizer’s vaccine raise hope that candidates of other lead COVID-19 vaccine developers may also get emergency approvals for their products rapidly, provided they prove their efficacy and safety in clinical studies. Multiple vaccines will be needed to inoculate the world’s population.
Other than Pfizer/BioNTech, Moderna (MRNA - Free Report) , AstraZeneca (AZN - Free Report) /Oxford University and J&J (JNJ - Free Report) are the lead players in the COVID-19 vaccine development race.
Though these companies will bring their vaccines later than Pfizer, their product may become more successful than Pfizer and they may not face any major trouble in gaining market share. Here’s why.
Moderna
Pfizer/BioNTech’s close competitor is Moderna, which 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. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis. An FDA committee is due to review Moderna’s vaccine on Dec 17. We expect that the FDA may immediately approve Moderna’s vaccine considering that it too has shown similar efficacy in late-stage studies.
This will make Moderna one of two early entrants in the COVID-19 vaccine space and it can reap in some early profits. Meanwhile, Moderna’s cold storage requirements are less stringent than Pfizer’s. Moderna’s vaccine can remain stable at standard refrigerator temperature (2°-8°C) for 30 days while Pfizer’s vaccine needs to be stored at extremely low temperatures (-70°C±10°C) for up to 15 days
AstraZeneca
Meanwhile, AstraZeneca/Oxford University’s potential COVID-19 vaccine candidate, AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies. AstraZeneca has begun submission of data to regulatory authorities around the world for early approval. If the necessary approvals are obtained, it may be able to launch its vaccine early next year.
In September, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, as a patient in U.K. suffered an unspecified illness. While studies in UK, Brazil, South Africa and Japan resumed in the weeks thereafter, following regulators’ confirmation, the study in the United States remained on hold for some time and resumed in late October. Though the temporary setback put AstraZeneca behind Pfizer and Moderna, the company is now back on track.
AstraZeneca’s vaccine is not a mRNA-based treatment like Pfizer and Moderna’s. It uses a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
AstraZeneca’s vaccine can be transported and stored at normal refrigerator temperatures (2°-8°C) for at least six months. AZD1222’s normal storage needs may give the company an advantage from logistics point of view as it makes it much easier to distribute globally using the normal immunization distribution system. Reportedly, AstraZeneca’s vaccine is also cheaper than others being priced at less than $3 a dose.
J&J
J&J’s COVID-19 vaccine candidate, JNJ-78436735 is being evaluated in the ENSEMBLE phase III study, which is expected to enroll 60,000 adult participants globally. The ENSEMBLE study was paused in October due to an unexplained illness observed in a study participant. The study was resumed later in the month as it was not clear whether the unexpected serious adversity was related to the vaccine shot.
J&J should report interim efficacy results for JNJ-78436735 early next year. If the data are positive and necessary regulatory approvals are received, J&J may launch its vaccine in the first quarter of 2021 and still have a large market share to capture. JNJ-78436735’s biggest advantage among the leading COVID-19 vaccines in that it requires only a single shot unlike those of Pfizer, AstraZeneca or Moderna.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
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