Here’s hoping Big Pharma come up quickly with something to beat Covid-19

Stuff’s  headline   ran “Vaccine  hopes  push sharemarket   higher”.

An  intriguing  one,  and sure  enough  Wall St had  rallied  on  news  the   drug  giant  Johnson & Johnson had   reported it  expects to begin human clinical tests  on a  vaccine  candidate  for  Covid-19  by  September.

Point  of Order  went in search  of  other  international  developments  being reported in the battle against  the Covid-19 pandemic.

In  the  UK,  the BBC reported  a breathing aid that can help keep coronavirus patients out of intensive care has been created in under a week.  University College London engineers worked with clinicians at UCLH and Mercedes Formula One to build the device, which delivers oxygen to the lungs without needing a ventilator.

Continuous Positive Airway Pressure (CPAP) devices are already used in hospitals but are in short supply. China and Italy used them to help Covid-19 patients.

The  BBC   said  40 of the new devices have been delivered to ULCH and to three other London hospitals. If trials go well, up  to 1,000 of the CPAP machines can be produced per day by Mercedes-AMG-HPP, beginning in a week’.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has already given its approval for their use.

Point of Order   would like to  see  the government   here  encourage  a  NZ  company  to  get a licence  from Mercedes  Formula  One to  manufacture those devices  here— particularly  as  ventilators  are  in  short supply, and in any case  can only  be used  by patients  under   medication.

Meanwhile   the   French government has  issued  a decree precisely framing and regulating the use of a treatment outside the traditional marketing authorisations for hydroxychloroquine, “which will be accessible to hospital medical teams who wish it”,

Earlier  the French Health Minister Olivier Véran  had indicated  that France’s High Council of Public Health had recommended not using hydroxychloroquine

“ … in the absence of a recommendation, with the exception of serious forms of hospitalisation and on the collegial decision of doctors and under strict medical supervision”.

Véran added that the High Council of Public Health

“ … excludes any prescription in the general population or for forms not severe at this stage, in the absence of any conclusive data”.

Interestingly, in parallel,  the Walter and Eliza Hall Institute of Medical Research in Melbourne  is engaged a clinical trial with the anti-malarial drug hydroxychloroquine for high-risk health workers. The institute  has invited doctors, nurses and other health workers across hospital departments who are at risk of acquiring infection to participate.

Health care workers are at the front line of the Covid-19 pandemic, and their exposure to the virus increases their risk of infection with SARS-CoV-2 – the virus that causes Covid-19 disease  and so the  institute  is targeting this group with the goal of reducing the impact on the health care work force so they are able to care for sick patients.

Beyond personal protective equipment, evidence is emerging that the drug hydroxychloroquine, used for more than 70 years to treat autoimmune conditions such as lupus, has clinically relevant antiviral activity that could prevent COVID-19.

Japanese conglomerate Fujifilm, most famous for its film and instant cameras,  but which also makes medical equipment,  has  come up  with a potential coronavirus treatment, a  drug called  Avigan.

In late February, when the  coronavirus had sickened 80,000 people worldwide  but the World Health Organisation had not yet declared a pandemic, Japan’s health minister said the government was considering using the drug Avigan, also known as favipiravir, to treat patients sickened by Covid-19. A month later, favipiravir has shown promise in two trials involving coronavirus patients, as more countries, all desperate for an answer to Covid-19, prepare to test its effectiveness.

Yet the drug remained relatively obscure—it’s not available on the market in Japan—until the coronavirus outbreak. Now, clinical trials in several countries are studying favipiravir’s effectiveness in combatting Covid-19, with some already reporting good results.

Trials in the Chinese cities of Wuhan and Shenzhen found that favipiravir was “clearly effective in treatment” of Covid-19.

By  far   the  most significant  news   in the   battle  against  Covid-19 came  from Johnson & Johnson, (which claims to be the world’s  largest  healthcare company),   so  Point of Order thought it  worth  reproducing  the  company’s statement  in some  detail.

The company  said  it  had  selected a lead Covid-19 vaccine candidate from constructs it has been working on since January 2020 together  with the rapid scaling of the company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.

Along  with that it  has expanded the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA).

It  expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorisation in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.

Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services, and Johnson & Johnson together have committed more than $US1bn to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.

Separately, BARDA and the company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding its global manufacturing capacity, including through the establishment of new US vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.

The company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.

Paul Stoffels, MD, Chief Scientific Officer, Johnson & Johnson, said  its global team of experts has ramped up R&D processes to unprecedented levels.

“We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January.  We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”

Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac® technology. Through collaborations with scientists at multiple academic institutions, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing.

Based on this work, Johnson & Johnson has identified a lead Covod-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the company is aiming to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021.

For comparison, the typical vaccine development process involves a number of different research stages, spanning five  to seven years, before a candidate is even considered for approval.

For more than 20 years, Johnson & Johnson has invested billions of dollars in antivirals and vaccine capabilities.

The Covid-19 vaccine program is leveraging Janssen’s proven AdVac® and PER.C6® technologies that provide the ability to rapidly develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the company’s Ebola vaccine and construct  Zika, RSV, and HIV vaccine candidates which are in Phase 2 or Phase 3 clinical development stages.

In addition to the vaccine development efforts, BARDA and Johnson & Johnson have expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The  aim is to identify potential treatments against the novel coronavirus. The antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.

Big  Pharma  companies  like  Johnson & Johnson may not be everyone’s favourite —but  let’s  hope  they get the job done in proving they can  come  up as  quickly as  they say  with a vaccine against  Covid-19. They will have earned the  gratitude of every potential  victim.