Yes, all clinical trial phases are important in vaccine development. However, circumstances may warrant a vaccine's approval for investigational use based on reassuring preliminary results from early trials, and used under strict monitoring. It is not clear whether the Russian vaccine meets the criteria for investigational use before it was 'approved' (there are no publications of data or findings from pre-clinical tests and early trials to show). There ere are also no clear indications that the planned use will be strictly monitored.

It's not about Russia, USA or China, it's the matter of safety and effectiveness dear Chukwudi A. Nnaji and thanks for sharing.

You are welcome, Muhammed. I only made reference to the Russian case to provide some context, since it's been in the news lately and people are much familiar with it. Investigational use of vaccines isn't new. It was used during the Ebola outbreak in DRC. However, like I said, such use has to be based on substantial evidence of immunogenicity and safety from pre-clinical studies and early trials. Cheers.

Thanks for sharing again dear Chukwudi A. Nnaji and the reality is too hard in this divided world and every one in the vaccine race and we need to break the monopoly business by ensuring equitable distribution of vaccines.

For the safety of a vaccine it is important to know about the secondary effects (testing first 1000 volunteer for example). For the effectiveness of the vaccine no one can tell without testing it, it may be low or high but a 100% effectiveness would be like hitting the jackpot. The first generation vaccine have always a lot of uncertainties

Think so sir Jean-Pierre Jost and thanks for sharing.

17 August, The Guardian

China’s vaccine specialist CanSino Biologics Inc has won a patent approval from Beijing for its Covid-19 vaccine candidate Ad5-nCOV, state media reported, citing documents from the country’s intellectual property regulator.

Issued on 11 August, the patent is the first Covid-19 vaccine patent granted by China, according to the state-owned newspaper People’s Daily. The patent is a commercial milestone, not a scientific one.

“The patent will prevent others from copying the vaccine but it is not an essential step for progressing the vaccine into more clinical trials,” Professor Marc Pellegrini, from the Walter and Eliza Hall Institute of Medical Research, told the Guardian.

Pellegrini noted the vaccine was published in the Lancet some weeks ago, around the same time as the Oxford group published their vaccine.

Both use the adenovirus (which causes common infections like the cold) to mimic the coat of Sars-CoV-2 and elicit immunity.

Saudi Arabia said this month it plans to begin Phase III clinical trials for the CanSino vaccine. CanSino has said it is also in talks with Russia, Brazil and Chile to launch Phase III trials in those countries.

CanSino’s Hong Kong shares rose around 14% in Monday’s morning session. Its Shanghai shares rose by 6.6% as of midday.

18 August, The Telegraph

England and Germany neck-and-neck in race to produce first vaccine

Experts say the result is too close to call but will be decided by evidence and data, not penalties

The race to produce the first fully licenced vaccine to protect against the new coronavirus may come down to a playoff between teams in England and Germany.

Kate Bingham, chair of the UK Vaccine Taskforce, the body in charge of the UK’s vaccine strategy, said on Monday that two groups - one in Oxford and one in Mainz, Germany - were running head to head and may yet see their immunisations approved before the end of December.

“I think we have a shot of getting a vaccine this year,” Ms Bingham told Sky News. “There's two potential candidates, one would be the Oxford candidate and the other one is the German vaccine from BioNTech.”

These candidates are among six the UK has already ordered (with a total of 340 million doses) as a means of hedging its bets against candidates returning poor data in phase three trials.

Ms Bingham said she was “very optimistic” about all six vaccines, which use four different technologies to fight Sars-Cov-2. She said early results from three were encouraging but singled out the Oxford and German teams as the most advanced.

“Those are the two that, if everything works, could potentially be both registered and delivered this year,” she said, with the caveat that “it is most likely to be next year, though.”

While the Oxford vaccine has received huge media coverage, the candidate being trialled by the German biotech company BioNTech has attracted fewer headlines.

Unlike the Oxford candidate, which requires a conventional manufacturing process, the German vaccine is an mRNA-based product. If proven to work, it can be synthesised in a laboratory at greater speed - a major advantage when almost eight billion people across the globe may need a jab. 

It’s a platform Thomas Strüngmann, BioNTech’s biggest shareholder, has claimed could make it “the Amazon of vaccines”.

Both products have completed successful phase one and two trials, with data suggesting they produced a “robust” immune response - antibodies and T-cells - in volunteers after two doses.

The teams are now conducting phase three trials in which tens of thousands of people in multiple locations around the world receive the jabs to demonstrate their safety at scale and their ability - not just to provoke an immune response - but to protect against the virus.

Dr Nick Jackson, head of programmes and technology at the Coalition for Epidemic Preparedness Innovations (Cepi), said one of the “distinct advantages” that both teams had was partnerships with big pharmaceutical businesses - something that had enabled them to scale up fast.

While the UK team is backed by the pharmaceutical giant AstraZeneca, the German team is supported by Pfizer. Governments across the globe have already signed contracts with both companies for billions of doses.

But buying a prospective vaccine is one thing, buying one that works is quite another. Although there is rising excitement about the race and scientific optimism a protective vaccine will eventually be found, many experts are still advising caution - historically as many as 35 per cent prove unsuccessful in phase three trials. 

Some may not work at all and while some may protect against the most severe coronavirus symptoms of Covid-19, they may not prevent transmission of the virus, warned Dr Jackson.

It is also unclear how long any protective effect will last and early trials have focused on healthy individuals between the ages of 18-55, meaning it is still unclear if vaccines will trigger an immune response in older, more vulnerable groups. 

Beate Kampmann, director of the Vaccine Centre at the London School of Hygiene and Tropical Medicine, is dubious about whether the Oxford or German vaccines will be available by the end of the year.

“They might have their phase three results [but] that’s all that can be said. I think, to use the word 'ready', is actually misleading,” she told The Telegraph, pointing to the considerable logistical hurdles around manufacturing and distribution.

Prof Kampmann added that the “assays they use are not directly comparable”, making side-by-side comparisons of the Oxford and German candidates less clear-cut. 

“The trials we need is head-to-head comparisons and analysis with the same methodology in the labs, but no one wants to do this at the moment,” she said. 

Of course these two vaccines are not alone in the race. There are four others in the UK portfolio, including two American candidates from Moderna and Novavax.

Meanwhile in China several vaccines are deep into human clinical trials - including the CanSino jab, which has already been given to the Chinese army and many travelling executives as part of phase three trials.  

More controversial is Russia's “Sputnik V” vaccine. According to the Russian government, mass-vaccination will begin come October - yet the jab is yet to enter phase three trials. 

“No regulator in the West would approve a vaccine that's only been trialled on 38 people,” Ms Bingham said when asked about the jab. “That doesn't prove whether it's safe or effective. It may be both, but on the back of 38 people you can't tell.”

Dr Jackson welcomed the race between Oxford and BioNtech but said he hoped for several victors. “It is a race in the sense that we need to go fast, but it's a race that needs multiple winners.

“It's only [with] several successful vaccines licenced in the UK [and] around the world that we're going to be able to deal with this pandemic. We need very large volumes and vaccines of different profiles for use around the world.”

Asked how close the Oxford versus BioNtech game might be, Dr Jackson said: “Will it go to penalties? No, I’m pleased to say it will be decided on evidence and data.”