While the public fears that the companies might cut corners to get a vaccine out under the government pressure, every step is being taken by the vaccine developers to make sure that a safe and efficacious vaccine is delivered to the public. In that wake, nine leading vaccine makers signed a pact which will prevent them from delivering vaccines under government pressure without conducting proper safety and efficacy tests.
By Ruchi Jhonsa, Ph.D.
Last week, AstraZeneca paused its late phase trial globally to review a neurological adverse reaction in a UK based patient. Pfizer/BioNTech expanded its trials by including 14000 more participants to get a better insight into the safety and efficacy of the vaccine. Russian government, which was criticized for cutting corners, also started the Phase 3 trial of its in-house vaccine to ensure the public’s safety.
AstraZeneca/Oxford University resumes global vaccine trials
AstraZeneca is currently leading the race of coronavirus vaccine. Its vaccine, AZD1222 is a weakened version of the chimpanzee common cold virus that contains the genetic material of novel coronavirus spike protein. The company had begun enrolling participants for the late trial in the UK, Brazil, and South Africa even before early trial data. However, AstraZeneca paused the trials globally after an adverse event of transverse myelitis in a patient enrolled in the UK cohort. However, the UK experts tasked with overseeing the complication informed on 12th September, six days after the pause, that everything is fine and recommended Medicines Health Regulatory Authority that it was safe to resume trials. However, AstraZeneca and the University of Oxford did not disclose any medical information related to the statement’s investigation. They will update all the relevant information in global clinical registries.
Pfizer/BioNTech to increase the diversity of participants in the vaccine trials
Second in the race is Pfizer and BioNtech’s vaccine, BNT162b2 that uses spike protein’s mRNA to induce an immune response in a human body. The duo announced that they had submitted their plans of increasing the size of the trials as well as the diversity of participants in the existing trials to the US Food and Drug Administration. According to the amended protocol, the company would add 14,000 more individuals to the initial count of participants, making 44,000 participants. This move will allow the pair to get better insights into the vaccine by collecting more safety and efficacy data. The company also plans to include adults as young as 16, people with stable HIV, and people infected with hepatitis C or hepatitis B in the trial. The company expects to reach the initial target of up to 30,000 participants this week.
China’s COVID-19 Nasal Spray
On 10th September, China approved phase 1 human testing of the nasal spray COVID-19 vaccine, co-developed by researchers at Xiamen University and Hong Kong University and vaccine developer Beijing Wantai Biological Pharmacy Enterprise Co. The Chinese nasal spray vaccine contains a weakened flu virus that carries the coronavirus spike protein’s genetic material. Like a natural infection, the nasal vaccine enters through the nasal tract trail to stimulate the body’s immune response. Scientists believe that a vaccine that mimics the natural infection route is better at setting an immune response than the injected vaccine. The vaccine has already shown efficacy in the preclinical trial. It successfully reduced lung damage in mice and hamsters challenged with the SARS-CoV-2 virus.
After approval, Russia advances the COVID-19 vaccine in the Phase 3 trial
Earlier last month, Russian health regulators approved the COVID-19 vaccine, Sputnik V developed by Gamaleya Research Institute in Moscow for countrywide use, while the vaccine’s efficacy is still in question. But, after backlash from critics in Russia and abroad, now, the Russian health ministry has tested the efficacy of the vaccine in a large cohort trial with 40000 volunteer participants at a medical institution in Moscow, as reported by CNN. According to the doctors in a medical institution in Moscow, “This important trial will help establish the Russian vaccine.” According to a study published in the British Medical Journal Lancet this month, the Gamaleya National Research Center’s Russian vaccine showed no severe health effects. While the phase 3 trial is underway, the Russian government has agreed to supply 32 million doses of Sputnik V vaccine to Mexico according to an agreement made between the Russian Direct Investment Fund and Landsteiner Scientific pharmaceutical company.
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