- Johnson & Johnson commenced pivotal global Phase 3 study of JNJ-78436735, Janssen’s COVID-19 vaccine candidate.
- J&J anticipates the 1st batch of its COVID-19 vaccine to be available for EUA in 2021 beginning, given that the vaccine demonstrated its safety & efficacy during trials.
- Novavax disclosed that it had commenced its first Phase 3 clinical trial for assessing the safety, efficacy, along with immunogenicity of its COVID-19 vaccine candidate.
The race of finding a potent vaccine or treatment for the ongoing deadly COVID-19 is still on. Healthcare companies, along with universities and institutes, are burning their midnight oil to find out the potential vaccine. There is an enormous urgency between countries across the world to immunise their citizens against COVID-19. The governments are also securing vaccine in advance for early access to fasten the process of immunisation in their country.
According to the current landscape provided by the World Health Organization on 30 September 2020, there are a total of 191 COVID-19 vaccines under development all over the world, and 41 of them have entered clinical development. Many healthcare companies are commencing late-stage clinical trials of their vaccine candidates.
Let us acquaint you with two companies who have recently initiated the Phase 3 clinical trial of their vaccine candidate-
J&J Initiates Phase 3 ENSEMBLE trial of its COVID-19 Vaccine Candidate
Johnson & Johnson (NYSE:JNJ) disclosed the start of its Phase 3 ENSEMBLE trial of the COVID-19 vaccine candidate, JNJ-78436735, on 23 September 2020. Phase 3 clinical study is a pivotal, large-scale, and multi-nation study. JNJ-78436735 is developed by Janssen Pharmaceutical Companies of J&J.
The Company commences ENSEMBLE trial after the JNJ-78436735 demonstrated positive interim findings in the Phase 1/2a study. The findings revealed that safety, along with immunogenicity after the single administration of vaccine candidate, was supportive for its further development.
Johnson & Johnson revealed that the interim results had been presented to medRxiv. Additionally, these findings are due to be published on online platforms. Based on these findings with subsequent discussion with the US FDA, Phase 3 trial will now enrol up to almost 60k subjects across three continents. ENSEMBLE trial shall examine the efficacy and safety of a single dose of Janssen’s COVID-19 vaccine candidate against placebo for preventing deadly coronavirus infection.
J&J is on track to meet its objective of delivering one billion COVID-19 vaccine doses each year and has continued expanding its production facility. The Company is committed to producing a potential at the same time, an affordable COVID-19 vaccine on a not-for-profit basis for emergency use for the duration of the pandemic. Moreover, J&J anticipates the 1st batches of its COVID-19 vaccine to be available for EUA (emergency use authorization) in 2021 beginning, given that if the vaccine demonstrated its safety & efficacy.
Johnson & Johnson’s Chairman and CEO, Alex Gorsky said-
COVID-19 vaccine candidate of Janssen utilises AdVac® technology platform. By using this technology platform, the COVID-19 vaccine is anticipated to remain stable for 2-years at -20°C temperature & for a minimum of 3-months at a temperature between 2-8°C.
This stability of vaccine candidate will be consistent with standard distribution channels of vaccine. It would not require new infrastructure to deliver it to the patients who need it on priority.
J&J Joins Expanded Global Access for COVID-19 Vaccine
On 30 September 2020, Johnson & Johnson disclosed that the Company signed a landmark communiqué on global access for COVID-19 vaccine with some other companies. The landmark is to make sure that the people everywhere have access to the potential COVID-19 ongoing innovations under development at the companies regardless of their income level.
As part of its commitment, J&J also plans to distribute up to almost 500 million COVID-19 vaccines to lower-income nations with delivery starting mid next year.
On 30 September 2020, JNJ share price was last noted at US$148.88, up by 1.24%, with a market capitalisation of US$391.97 billion.
Novavax Starts Phase 3 Trial of COVID-19 Vaccine in the UK
Late-stage biotechnology player Novavax Inc (Nasdaq:NVAX) is engaged in the development of next-generation vaccines for serious infectious disorders.
On 24 September 2020, Novavax revealed that the Company initiated its first Phase 3 clinical trial for assessing the safety, efficacy, as well as immunogenicity of ‘NVX-CoV2373’, COVID-19 vaccine candidate of Novavax. The Company unveiled that the clinical study is being performed in the UK, in partnership with the Vaccines Taskforce of the UK Government.
Novavax is anticipated to enrol and immunise up to 10k volunteers aged between 18-84 years, with & with no significant comorbidities, for the time of next 4-6 weeks. Moreover, Novavax also stated that the data from this clinical study is anticipated to provide support for regulatory submissions for licensure in the EU, the UK, including other nations.
President, R&D at Novavax Gregory M. Glenn, MD, stated-
The Company stated that it has continued to increase its production capacity for COVID-19 vaccine currently at up to 2 billion doses each year once all facilities have been brought online by mid-2021.
On 30 September 2020, NVAX share price was last noted at US$108.35, up by 0.37% with a market capitalisation of US$6.63 billion.
With the pandemic continuing to affect the globe, healthcare companies are evaluating their lead compounds for COVID-19 treatment. Future revenue for these stocks depends on the probability of launching an approved treatment in the market.