Covid-19 Vaccines Hit Roadblocks – In 24 Hours, Eli Lilly And Johnson & Johnson’s Trials Suspended Over Safety Concerns

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Oct 15 2020
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If you think an effective vaccine for Covid-19 will be available before Christmas this year, you would be disappointed. Unless you don’t mind trying Russian-developed vaccine – “Sputnik V” – which is already available, a United States FDA-approved vaccine won’t happen until next year. The virus is still spreading rapidly, with over 1-million deaths and 37-million infections.


Hopes for a rapid vaccine rollout suffered a setback after U.S. pharmaceutical firm Eli Lilly announced on Tuesday that it had suspended its Phase 3 trial of a combination antibody treatment for Covid-19 for safety reasons. Although the U.S. drugmaker did not reveal what had happened, usually, clinical trials are suspended because a volunteer has suffered a side effect or become ill.


Apparently, Eli Lilly is testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with Covid-19. The purpose of the treatment is to give the immune system a head start on fighting the virus. It is similar to that made by Regeneron Pharmaceuticals that was given to President Donald Trump earlier this month.

Coronavirus - Vaccine for Covid-19 Trial on Patient

In August, the U.S. National Institutes of Health began testing Lilly’s monoclonal antibody, also known as LY-CoV555, in Covid-19 patients. The antibody therapy is being developed with Canadian biotech AbCellera Biologics Inc. Both Lilly and Regeneron have approached the U.S. FDA (Food and Drug Administration) seeking emergency use authorization for their treatments.


Lilly’s suspension is the second in less than 24 hours after another drugmaker, Johnson & Johnson, hit a similar problem. While Eli Lilly’s is for a therapy, Johnson & Johnson’s is for a vaccine called “JNJ-78436735”. There was little information, but Johnson & Johnson confirmed that it has halted its vaccine trial due to “an unexplained illness” in a study participant.


Late last month, Johnson & Johnson began testing its one-shot vaccine in a late-stage clinical trial with up to 60,000 participants. The U.S. pharmaceutical company is one of the manufacturers backed by Operation Warp Speed, an ambitious Trump initiative with US$10 billion funding to create a vaccine by the end of the year, even though experts warned that at least 18 months is needed to do so.

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But Eli Lilly and Johnson & Johnson are not the only drugmakers that hit roadblocks. The first major setback happened in September when British pharmaceutical AstraZeneca suspended its vaccine clinical trial at least twice to investigate two cases of severe illness developed by participants. The U.S. has signed a US$1.2 billion contract with AstraZeneca to make 300 million doses of its vaccine.


One volunteer in a trial in the United Kingdom apparently developed a serious neurological problem after receiving the vaccine – AZD1222 – developed based on technology developed by Oxford University. Earlier in July, AstraZeneca also stopped a clinical trial briefly because another participant developed neurological symptoms.


Interestingly, Covid vaccines based on adenovirus vectors, like the one being developed – and hit problems – by both AstraZeneca and Johnson & Johnson, are already approved for use in Russia and in China. Naturally, the suspension of Johnson & Johnson and Eli Lilly’s clinical trials have raised safety concerns over Covid-19 vaccines and drugs in China.

Coronavirus - Eli Lilly Biotechnology Centre

The vaccines developed by Johnson & Johnson and Oxford-AstraZeneca used the same method co-developed by Chinese vaccine developer CanSino Biologics Inc. However, China claims that the two vaccines developed by the American and British drugmakers use chimpanzee-derived adenovirus as vectors, while CanSino uses human adenovirus.


Wang Ying, a Shanghai-based immunologist, said while there is no evidence to prove that human adenovirus is safer than chimpanzee adenovirus in vaccines, China uses multiple methods to ensure a higher success rate. China has been taking five technical routes to find vaccines against the disease – inactivated vaccines, adenoviral vector-based vaccines, live attenuated influenza vaccines, DNA and mRNA vaccines.


Experts say the suspension of vaccine trials from Johnson & Johnson and AstraZeneca as well as a treatment from Eli Lilly demonstrates that the system to protect participants’ safety is working. But at the same time, it’s troublesome as President Trump has called for immediate Emergency Use Authorization of the Lilly treatment along with that of Regeneron.

Coronavirus - British AstraZeneca Building

The limited information from the American drugmakers about the reason for the suspension has created suspicions. According to a new poll from Informa Pharma Intelligence and research firm YouGov, 35% of Americans don’t trust how quickly the Covid-19 vaccine clinical trials are moving, and 23% say they don’t think pharmaceutical companies have consumers’ best interests in mind.


Currently, there are 49 Covid-19 vaccines in clinical trials around the world, and nine of them are in late-stage studies. Yet, there’s a huge challenge with vaccines. Unlike a dying cancer patient who might be willing to take any medication with lots of side effects, vaccines are given to healthy people. Therefore, pharmaceutical companies cannot afford to have a mistake.


Pfizer and Moderna are the two U.S. companies most likely to first announce results from late-stage testing of their respective Coronavirus vaccine. But with public’s unrealistic expectations of a vaccine that’s “100% effective and 200% safe”, even both Pfizer and Moderna cannot guarantee there won’t be any delay in the results of their tests.

Coronavirus - Vaccine


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