With vaccine diplomacy, Russia and China are gaining leverage on the cheap while fulfilling commercial goals. In most cases, they are not donating vaccines, but selling them - Photo by Chinnapon

JAKARTA (TheInsiderStories) – The most sought-after goal in tackling the global COVID-19 pandemic will be the development of an effective vaccine that induces effective and long-lasting immunity against the virus, said IHS Markit in the latest report released today. So far, twenty-eight COVID-19 vaccine candidates are currently in clinical trials.

To date, five vaccine candidates from AstraZeneca (Britain), Sinovac (China), Moderna (America), and two from Sinopharm (China) have entered Phase III development, one is in Phase II/III (from a collaboration between BioNTech from Germany and US’ Pfizer), two are in Phase II, and several more are in Phase I/II and Phase I.

One Phase I/II candidate from the Gamaleya Institut has received a temporary authorization for public access on limited open-label basis in Russia, prior to entering Phase III development, although little evidence has been released on the efficacy of this candidate. In addition, selected promising preclinical-stage projects (some of which are very close to initiating clinical development) have been listed. The success of any of these will depend on safety, level of immunogenicity, and duration of protection.

“Although there is still considerable uncertainty about the duration of protective immunity developed after COVID-19 infection and the feasibility of generating an effective vaccine with any long-term effect, a large number of researchers and companies have initiated vaccine projects, using a broad mix of established and innovative technologies,” said Gustav Ando, head of life sciences and industry services from IHS Markit.

He added, ” The development for COVID-19 has been accelerated considerably by acquired knowledge developed during the generation of candidate vaccines for related SARS and MERS coronaviruses, as well as recent research into Ebola vaccines.”

In details, on August 11, the Russian Ministry of Health granted a temporary registration certificate for the Gamaleya Institute’ candidate COVID-19 vaccine Gam-Covid-Vac, now named Sputnik V. This will allow public access on a limited scale ahead of the completion of Phase III trials, which have not yet started, but are due to roll out in multiple global locations including Russia, plus potentially Brazil, India, Mexico, the Philippines, Saudi Arabia, or the United Arab Emirates, in around 2,000 people.

Sputnik V has completed two open-label Phase I/II trials without placebo controls in a total of only 76 volunteers and limited clinical data have been released in the public domain. Recent communications from the Gamaleya Institute have clarified that proposed public access to the vaccine would be on a limited scale such as health workers and that recipients would be closely monitored as part of an open-label section in the Phase III trial.

The mass production is targeting starting September 2020 and larger-scale public access from January 2021, as stated on the registration certificate. Results from a Phase I/II placebo-controlled, observer-blinded Phase I/II trial evaluating candidate vaccine BNT162b1 from Pfizer and BioNTech in 45 healthy adults aged 18–55 have been published in Nature.

In the trial, doses of 10 mcg, 30 mcg, and 100 mcg were well tolerated, as were double doses at the two lower levels (21 days apart), although a second vaccination with 100 mcg was not administered because of increased reactogenicity and little increased immunogenicity of the first dose compared with 30 mcg. RBD-binding IgG concentrations and SARS-CoV-2 neutralising titres in sera increased with dose level and after a second dose.

Geometric mean neutralising titres (GMTs) produced by vaccination reached 1.9–4.6 times that observed in a panel of COVID-19 convalescent human sera retrieved at least 14 days after a positive SARS-CoV-2 test. While, Novavax from US has announced a licence agreement with the Serum Institute of India (SII) for the development and commercialization of its vaccine candidate NVX-CoV2373 in India and in other low- and middle-income countries (LMICs), and has also secured a deal with Takeda for local development, manufacturing, and commercialisation in Japan.

CanSino (China) has secured an agreement to commence a placebo-controlled Phase III trial of its candidate vaccine Ad5-nCoV in Saudi Arabia. The trial will commence shortly in around 5,000 volunteers in the cities of Riyadh, Dammam, and Mecca. CanSino declared its readiness for Phase III late last month and had been conducting discussions with additional countries outside China such as Brazil, Chile, and Russia.

Sinovac and Indonesian state-owned firm PT Bio Farma launched a Phase III trial on August 11 in Indonesia to test COVID-19 vaccine candidate, CoronaVac, in up to 1,620 participants across six locations. The study has so far recruited 1,215 volunteers between the age group of 18 to 59 over five stages of testing and the study is expected to last six months.

Bio Farma will be commencing production of the vaccine in the first quarter of 2021, subject to Phase III success, according to the source. The health ministry in Bahrain also has confirmed that local Phase III testing for Sinopharm’ COVID-19 vaccine has commenced. The trial will enrol 6,000 citizens and residents in the country over 12 months.

Sinovac has published preliminary Phase II data for its adjuvanted inactivated virus vaccine candidate CoronaVac, which is currently in Phase III development. The trials, which involved 600 participants, reportedly produced an antibody immune-based response with a favourable safety profile. No dose-related safety concerns were identified. The preliminary results have been published via medRxiv, and a more detailed release is expected to be published shortly.

Then, Mexican foreign ministry have signed memorandums of understanding with CanSino and Johnson and Johnson to conduct late-stage clinical trials of their respective vaccine candidates, between September 2020 and January 2021, assuming approval for the trials is finalised by COFEPRIS. The agreement has also been agreed between Mexico and Walvax Biotechnology for potential trials of Walvax’s candidate, currently undergoing early testing in China.

“In the absence of a vaccine, effective therapeutics for COVID-19 and its complications are urgently being sought to help mitigate the most serious consequences of infection and to reduce the duration of virus shedding and infectivity,” Ando stated.

This is, he added, especially important since the timeline for approval of a repurposed known medicine would be much shorter than that for a vaccine, since basic safety should already be established. Recently, said the analyst, there has been a major research effort worldwide, with hundreds of trials and investigations having been initiated for a wide range of existing and novel compounds, although success so far has been relatively limited.

IHS Markit has evaluated current evidence and status for a selection of promising medicines under evaluation for COVID-19 infection and its complications. Many of the drugs under the closest scrutiny currently are repurposed versions of existing medicines that have established safety profiles and could be approved relatively quickly, once the evidence base is confirmed to be adequate.

Edited by Editorial Staff, Email: theinsiderstories@gmail.com