Besides saving lives and the global economy, we are expecting three things from the upcoming COVID-19 vaccine: safety, immunogenicity and efficacy. But we never had a 100 percent efficacy when it comes to respiratory viruses, so anything between 50 and 100% will be the best we've got as the WHO believes everything above 50 percent efficacy is acceptable. So, how far away are we from this goal?
Buoyed by positive results in its earlier studies, Johnson & Johnson (NYSE: JNJ) has now entered the final stage of clinical trials for its COVID-19 candidate. Although they started a couple of months behind others in the U.S., its trials will by far be the largest with 60,000 enrolled participants.
The Advantage Of J&J Candidate – One Dose And No Sub-Zero Storage Temperatures
J&J's vaccine is made with a slightly different technology than others as it is modeled on its prior Ebola vaccine. It could result in considerable advantages over some of its competitors in terms of dosage and storage. But it's up to Phase 3 trials that compare the effects of a vaccine with those of a placebo to determine if a single dose is indeed effective.
Disadvantages Of Moderna And Pfizer Candidates – Significant Logistics Hurdle
Adenovirus vaccines must be kept refrigerated but not frozen, unlike the two front-runner vaccines, by Moderna Inc (NASDAQ: MRNA) and Pfizer Inc. (NYSE: PFE). These depend on bits of genetic material known as mRNA. Besides the freezing requirement that makes distribution problematic, their vaccines also need to be taken in two doses, a few weeks apart.
When participants received a dose more than double the strength of the current shot of the Moderna vaccine, 20 percent experienced significant adverse effects such as fever and severe headaches. AstraZeneca was forced to pause its study for the same reason. Although the trial resumed in the UK and elsewhere, the research remains on hold in the US.
Candidates – U.S.
Johnson & Johnson is now the fourth company to begin large-scale clinical trials for a COVID-19 vaccine in the United States, behind Moderna, Pfizer/BioNTech SE (NASDAQ: BNTX) and AstraZeneca plc (NYSE: AZN). According to Anthony S. Fauci M.D., this is an unprecedented speed made possible by decades of progress in vaccine technology and a coordinated approach that expanded beyond the scientific community, supported by governments and industries.
Financial Times has reported that there is a total of more than 300 vaccine candidates, according to the World Health Organization. Less than half are being tested on humans. Only nine of those have reached phase 3 trails which is the final stage before possible implementation. One of the nine vaccines is UK's AstraZeneca. Two of the most advanced U.S. candidates come from pharmaceutical company Pfizer, in partnership with Germany's BioNTech and Moderna. Four vaccines are being produced in China by Sinovac Biotech and one in Russia by the Gamaleya Research Institute which just boarded the phase 3 train this month. Then, there are Cansino Biologics Inc (OTC: CASBF) and Sinopharm Group ADR (OTC: SHTDY), which has two different shots in development and one is being led by Johnson & Johnson. All nine have already signed purchase agreements with governments around the world.
According to data from Deutsche Bank, the UK has built the largest and most diversified vaccine portfolio, on a per-capita basis, having pre-ordered more than five doses per citizen spread across six leading vaccine candidates. It is closely followed by the U.S., Canada and Japan.
When it comes to the overall spender, the US government's Biomedical Advanced Research and Development Authority has distributed more than $10 billion in funding for vaccine candidates, either via direct financing or through vaccine procurement agreements.
Canada has allocated $1 billion to secure at least 154 million doses of a future vaccine, signing deals with Pfizer, Moderna Inc, Johnson & Johnson, and Novavax Group (NASDAQ: NVAX) and most recently, Sanofi SA (NASDAQ: SNY).
The stated objective of the AstraZeneca, Moderna, Pfizer/BioNTech and J&J vaccines is to prevent the life-endangering symptoms of Covid-19. Their goal is to prevent people from being admitted to the hospital, going to intensive care and dying, as summarized by Andrew Pollard, who is leading the AstraZeneca trials at Oxford University. But preventing an asymptomatic infection entirely is likely to be a much bigger hurdle. Given the growing chorus of experts warning that vaccines will only offer a temporary immunity, making subsequent shots just as important. Only Johnson & Johnson and CanSino Biologics Inc are aiming for single-dose shots.
If successful, Johnson & Johnson expects the first doses to be up for emergency use authorization from the U.S. FDA at the beginning of next year, while on track to make a billion doses a year. If this is the case, it would greatly help efforts to curb the pandemic.
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