Pfizer’s BNT162b2 appears to be in the lead of all “Western” vaccines that have any chance for emergency use authorization (EUA) before the end of 2020. Ironically, the Pfizer and BioNTech (original developer) partnership didn’t accept any government subsidy funds via Operation Warp Speed (OWS) and associated agencies (e.g. BARDA). After all, it was this joint federal public-private partnership that drove the message to the public, via POTUS, that a vaccine would be ready for use by Jan. 2021 and perhaps even sooner. The Pfizer/BioNTech partnership’s vaccine candidate is certainly the front runner at this point in America. However, as reported Sunday by Yahoo Finance, Pfizer is now accepting the U.S. Food and Drug Administration’s (FDA) pushback for at least a two month-review time before any EUA acceptance. This topic will be discussed at a forthcoming October 22 FDA advisory council meeting. If all goes well, there is certainly a probability that Pfizer may be able to disclose key study data by the end of this month (as promised by their CEO) and possibly secure an EUA approval before the end of the year—but not before the election. The other Western vaccines, such as AstraZeneca’s AZD1222 (Oxford vaccine), is still on hold by the FDA in the United States; however, the Phase 3 trial has resumed in the UK and India. It’s possible that AZD1222 could be part of an EUA before end of year—but not in the United States. Moderna’s on record that it will be able to share initial data involving the trials of mRNA-1273 around Thanksgiving so that OWS-funded endeavor won’t see any EUA until early 2021 at the earliest, assuming all data points to safety and efficacy.
Other vaccines out of the “West” include CureVac (Germany), Johnson & Johnson- (JNJ-78436735–USA–on a safety pause), Novavax (USA) as well as Inovio Pharmaceuticals (USA). An entire list, courtesy of the World Health Organization (WHO) including all relevant COVID-19 vaccine candidates can be viewed here.
East Moves Faster (but Risks for safety issues are higher)
Overall, the East (e.g. Russia and China) have moved to expedite their pivotal COVID-19 vaccines at a drastically accelerated pace as compared to the West. But as TrialSite has stated in previous articles, its better to be safe than sorry.
Regardless, in more democratic, individualistic societies, all things being equal, it’s generally more challenging for central governments to corral the masses into lining up for experimental vaccines, at least not overtly. What follows is a brief summary of some updates of the expedited vaccines targeting COVID-19. In addition to WHO’s website, Precision Vaccinations represents a useful resource for vaccine status.
Sputnik V (status: approved in Russia; Phase 3 elsewhere)
The “Gamaleya Institute vaccine” known as Sputnik V was “registered,” meaning it was approved for use by Russian health authorities in an unprecedented move back in August. What appeared to be part of a “Vaccine Nationalism” movement, the Russians took very aggressive, ambitious and unusually unorthodox approach to ensure that this investigational product beat out all others. Associated short cuts involved not only uncomfortably fast-tracked Phase 1 and Phase 2 studies but also a complete bypassing of a pivotal Phase 3 clinical trial. Rather, the Ministry of Health of the Russian Federation approved the product and then required a series of Phase 3 studies both at home and abroad. TrialSite chronicled must of this activity and suggested economic development and diversification was also a motive.
Russia also engaged in other highly questionable tactics in association with Sputnik V, including ultra-unorthodox human challenge testing possibly done even before the first Phase 1 clinical trial commenced.
Russia via the COVID-19 activated and directed sovereign fund called the Russia Direct Investment Fund (RDIF) has been actively leveraging this vaccine as a business development and diplomatic tool doing deals in places like United Arab Emirates (UAE) and India. Stanford and Harvard educated Kirill Dmitriev has led the charge. In fact, Mr. Dmitriev, an impressive deal maker, even stepped up to take the Sputnik inoculation during the human challenge testing—part of an elite VIP cohort.
Sinovac’s CoronaVac (status: EUA with high risked groups in China)
By Aug. 28th, CoronaVac (Sinovac) was approved for emergency use in China for high risk groups. By Sept. 6, Sinovac reported that 90% of the company’s employees (and their families) had received the experimental vaccine which is still in Phase 3 trials.
By Sept. 23, SinoVac disclosed that China’s National Medical Products Administration approved a clinical trial involving the use of CoronaVac in adolescents and children back on Aug. 10.
Sinovac’s vaccine is under investigation in multiple countries from Turkey and Brazil to Indonesia. TrialSite and others reported that Sao Paulo’s government inked a deal to procure 46 million doses at a price point that still must be finalized. Most recently, the center for disease control associated with the Chinese city of Jiaxing disclosed CoronaVac would cost $29.75 per dose and that key vaccinations of medical professionals and other at risk groups had commenced.
TrialSite reported recently that this same vaccine may be part of an emergency use declaration in Indonesia shortly.
Cansino Biologics (status: EUA for Chinese Military)
CanSino Biologics Ad5-nCoV was jointly developed with the Beijing Institute of Biotechnology (BIB), Academy of Military Medical Sciences; it became the first of its kind that entered clinical development by March 2020. The founders actually came up with the idea for the company while residing in Canada.
By late June, the Chinese authorities approved a form of EUA to allow members of the Chinese military access to the CanSino Biologics’ vaccine called Ad5-nCoV. Of course, vaccine nationalism led to a real bad taste in Canada’s mouth as they entered into a strategic deal with the company but never received the product due to political tensions. Canada moved on to a ‘Plan B.’
The company has since announced a number of alliances, including with a Russian biopharma company called Petrovax. The company recently announced a deal with Mexico to supply 35 million doses of Ad5-nC0V starting the end of 2020 and into 2021.
Sinopharm (status EUA in China and UAE)
Sinopharm’s vaccine, developed from a SARS-CoV-2 strain isolated from a COVID-19 patient in the Jinyintan Hospital, Wuhan, was developed and cultivated in a qualified Vero cell line for propagation with the supernatant of the infected cells inactivated with β -propiolactone, reported its researchers.
Sinopharm is part of state-owned China National Pharmaceutical Group Co. Ltd., a large healthcare group with over 120,000 employees. By September 15, United Arab Emirates (UAE) announced its’ health authority had granted emergency use for health workers to use to prevent COVID-19 while still under Phase 3 testing. Health minister Abdulrahman Al-Owais reported that the vaccine would be available for “first-line-of-defense heroes, who are most at risk of catching COVID-19, protecting them from any danger that they may be exposed to due to the nature of their work.”
Sinopharm’s vaccine was accepted for Phase 3 clinical trials in a number of nations by Sept., including UAE, Bahrain, Peru, Morocco, Argentina and Jordan.
By Sept. 25, news accounts had Sinopharm’s vaccine used on at least 350,000 people in China outside of clinical trials, which had a total of about 40,000 enrolled last month.
Already, Chinese companies were scrutinized by the West for inoculating top executives and scientists with experimental vaccines (including Sinopharm), much like Russia was doing with Sputnik V. Sinopharm, state-owned, was quite active with these human challenge studies before human trials even started to test safety and efficacy according to some accounts. This type of practice wouldn’t be acceptable in the West.
On the other hand, TrialSite hasn’t been able to pick up on any material safety signals associated with vaccines in Russia or China. In fact, the only data points for safety pauses thus far occurred in the West (USA). But perhaps that’s because the regulatory authorities are more independent than other facets of central government?