Covid 19 Vaccine Tracker: How Close Are We?

If all goes well, there will be potential to get answers on which vaccines work by the end of the year.

All the major experimental vaccines for Covid 19 are expected to go into late-stage trials in July. They will be subject to large-scale studies. Through these studies, researchers will try to ascertain which vaccine candidates can fend off this deadly virus.

This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials. we have not covered those candidates which are in pre-clinical stages of development and research.

Moderna Therapeutics

Stage: Phase 2

Israel is in advanced talks with Moderna Inc to buy its coronavirus vaccine that is entering the final stage of testing, leading Israeli news website YNET reported on June 14.

Moderna’s coronavirus vaccine is in second-stage trials, with final-stage trials set to begin in July 2020 on 30,000 people. In an interview on Bloomberg Television on June 15  with David Rubenstein, Moderna Inc. Chief Executive Officer Stephane Bancel said in a best-case scenario “we could have efficacy data by Thanksgiving. This is the best time line.”

The trial is set to be performed in partnership with the US National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID). It will enrol about 30,000 participants in the US.

The primary endpoint of the Phase III trial is the prevention of symptomatic Covid-19 disease while key secondary endpoints include the prevention of severe Covid-19 and SARS-CoV-2 infection.

The primary efficacy analysis will depend on the number of participants having symptomatic Covid-19.

Based on the Phase I trial data, the 100μg dose was selected as the optimal dose level to maximise the immune response and minimise adverse reactions.

CoronaVac By Sinovac Biotech

Stage: Phase 2

Two doses of Sinovac Biotech’s COVID-19 vaccine candidate, dubbed CoronaVac, induced neutralizing antibodies 14 days after vaccination. More than 90% of the 600 healthy volunteers in the phase 2 part of the phase 1/2 study showed that immune response, the Nasdaq-listed company said on June 13.

The shot uses inactivated virus to stimulate an immune response, a proven method—unlike most vaccine candidates racing ahead in the U.S. But inactivated vaccines are more time-consuming to produce than the next-gen shots based on the virus’s genetic material.

Sinovac penned a deal with Brazilian immunobiologic producer Instituto Butantan to run the vaccine’s phase 3 in Brazil. In return, Instituto Butantan gains license to the investigational shot in its home country.

IN0-480 By Inovio Pharmaceuticals

Stage: Phase 2

Inovio Pharmaceuticals has reported promising data from the preclinical studies of its Covid-19 vaccine candidate, IN0-480, in mice and guinea pigs.

The candidate allegedly generated ‘robust’ neutralising antibodies and T-cell responses against SARS-CoV-2, the novel coronavirus that causes Covid-19.

Inovio and its partners at The Wistar Institute, the University of Texas, Public Health England, Fudan University and Advaccine published these findings in Nature Communications journal.

Inovio Pharmaceuticals has signed an agreement with German contract manufacturer Richter-Helm BioLogics for large-scale production of Covid-19 DNA vaccine candidate, INO-4800.

The deal, partially funded by a $1.3m initial grant from the Coalition for Epidemic Preparedness Innovations (CEPI), includes a total of $17.2m support for INO-4800 development.

Richter-Helm BioLogics has been manufacturing Inovio’s other DNA drug candidate VGX-3100 has been in manufacture since 2014, which is currently in Phase III clinical trials to treat precancerous cervical dysplasia caused by high-risk human papillomavirus (HPV).

University of Oxford

Stage: Phase 1

The phase I trial in healthy adult volunteers began in April. More than 1,000 immunisations have been completed and follow-up is currently ongoing.

The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions across the country.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children:

  • Aged 56-69
    • Aged over 70
    • Aged between 5-12 years

For these groups, researchers will be assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children.

The phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18. This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19.

Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison.

ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to replicate in humans.

Professor Andrew Pollard, head of the Oxford Vaccine Group, said: ‘The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population. We are very grateful to the huge support of the trial volunteers in helping test whether this new vaccine could protect humans against the pandemic coronavirus.’

AstraZeneca has joined forces with the UK government to support a COVID-19 vaccine developed by the University of Oxford.

Firms have already reached agreements to supply around two billion doses across the world.

BioNTech

Stage: Phase 1

Gernam firm BioNTech SE on June 16 closed USD112.55 million debt financing agreement to support the development of the company’s COVID-19 vaccine program BNT162. The EIB debt will be disbursed in two tranches of USD56.28 million each, following completion of pre-defined milestones.

BioNTech is the first European company to enter clinical tests of a COVID-19 vaccine product: they initiated a study in Germany in April and an additional trial in the United States at the beginning of May. The BNT162 campaign includes four vaccine candidates being tested in parallel, making it one of the broadest development programs worldwide.

The mRNA-based vaccine stimulates the immune system to generate protective, long-lasting antibody and T cell responses against SARS-CoV-2 and prevent subsequent infection upon exposure to the virus.

Novavax

Stage: Phase 1

Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on May 11, announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax’ coronavirus vaccine candidate against SARS-CoV-2.

The additional funding from CEPI will also support rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as Novavax’ proprietary Matrix-M™ adjuvant, which is expected to enhance immune responses by stimulating high levels of neutralizing antibodies. In addition, the CEPI funding will allow Novavax to dramatically increase its large-scale manufacturing capacity for both antigen and adjuvant in multiple locations.

Novavax plans to use CEPI funding to advance NVX-CoV2373 with:

  • A Phase 1/2 clinical trial with the Phase I portion starting this month in Australia and the Phase 2 portion conducted in multiple countries following successful Phase 1 top-line results that are expected in July.
  • Process development for scaled-up production to potentially allow manufacturing of up to 100 million vaccine doses by end of 2020.
  • Access to large-scale manufacturing capacity in multiple countries with a goal of potentially producing over one billion doses during 2021.

 

 

 

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