COVID-19: Why We Need to be Skeptical About Early Vaccine Claims

For a world desperate for a fix to COVID despair, any news is good news, but do these claims hold up to scrutiny?

Updated
Coronavirus
4 min read
COVID-19 Vaccine development: US-based Moderna's claims of early success lack data.
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In the last one week there has been a flurry of activity around treatments and vaccines for COVID-19. From makers of ‘Lucky Strike’ Cigarettes, a potential vaccine that can tackle COVID-19 made with Tobacco leaves; from a relatively small biotech company in the US, an antibody that can ‘block COVID-19 100% in experiments’; and US-based Moderna claiming early success in its COVID-19 vaccine being developed in partnership with National Institute of Allergy and Infectious Diseases (NIAID).

For a world desperate for a quick fix to COVID despair, any bit of news is good news, a ray of hope, a potential ‘back to normal.’

But do these claims hold up to scrutiny? How relevant is the information shared, what does the actual data show? Does the science hold up to scientific rigour?

As Dr Jayprakash Muliyil, a leading epidemiologist in India, warns,

"Right now, everything is exciting for us. There isn't any harm in getting excited. Our science and technology is advanced enough for there to be a vaccine in the future." But, he adds,

The only factor we are worried about is money. Money and greed can complicate matters by making people sell unsafe vaccines. We don't want that. This is the only concern. The science is not a cause for worry, greed is."

Stocks of the above companies soared shortly after the press releases went out, even as scientists asked, ‘where’s the data?’

Moderna's 'Early' Success

Let’s tackle Moderna’s vaccine first.

A news broke on 18 May that a coronavirus vaccine by US-based Moderna appears to be safe and able to stimulate an immune response against the infection in 8 healthy subjects. The technology in use is relatively new - it involves using genetic material from the virus called mRNA, short for messenger RNA, which directs the body’s cells to stimulate the immune system. The vaccine, developed using previous studies of related coronaviruses such as SARS and MERS, had earlier shown promise in animal models.

So this is good news, right?

An examination by medical publication StatNews raises several questions.

The trial involved 45 subjects, who received doses of 25 micrograms (two doses each), 100 micrograms (two doses each), or a 250 micrograms (one dose) developed binding antibodies.

Eight volunteers — four each from the 25-microgram and 100-microgram arms — developed neutralizing antibodies similar to those found in convalescent serum of patients who recovered from COVID-19.

So, what of the other 37 candidates? Data for them is yet to be released, and till that is clear, it is difficult to come to conclusions. While the Phase 1 clinical trial included healthy volunteers ages 18 to 55 years, what was the age group of these 8? That data is not out yet.

How long will these antibodies last? What level of antibodies were created? Data? Unclear.

Willian Haseltine, former Harvard Medical School Professor, in a scathing article in The Washington Post, called Moderna’s claims ‘publication by press release.’

The method used by Moderna has not been used to create any vaccine so far. If they succeed, that’s excellent news. But caution comes from another ‘most exciting’ vaccine, the one being developed by Oxford University.

Oxford Vaccine - Animal Trials Under Question

In early April, a professor at Oxford University’s ‘Jenner Institute’ was “80 per cent certain” that the world would see a vaccine for the deadly novel coronavirus by September 2020. Towards the end of April, scientists from the Jenner Institute in Oxford announced that their vaccine had passed the animal trials round and would soon be moving onto human trials.

According to this New York Times article, the animals - six rhesus macaque monkeys - were injected with heavy doses of the vaccine and then exposed to the novel coronavirus. After 28 days, the six monkeys were all healthy. These monkeys are selected as they are the closest to humans.

But a review paper on BioRxiv raised questions about the animal trial claims. The paper says the vaccinated monkeys did become infected with COVID-19. The authors of review said that while the vaccine did not completely prevent the animals from getting an infection, it did moderate the disease.

One way to test infection is by measuring the amount of virus in the lungs. “Viral RNA was detected in the lungs of 2 of the 6 vaccinated animals and in all three unvaccinated animals, again suggesting only partial protection.”

At best, the review suggests the vaccine offers partial protection.

Again, the vaccine remains in trial phase. It may yet work, but we have wait for openly shared data to make those 'early success' claims.

A Tobacco-Based Vaccine?

On 16 May, cigarette maker British American Tobacco (BAT) claimed it is ready to test its potential COVID-19 vaccine using proteins from tobacco leaves. The company claimed it was ready for human trials, as pre-clinical trials generated a positive immune response. They are awaiting approval from US Food and Drug Administration (USFDA) to proceed to Phase 1 human trials.

Tobacco being used for public health? The website does not clarify exactly what type of vaccine they will create.

"From my knowledge of the field I am assuming they will produce the virus Spike protein in tobacco leaves. It would then be purified and used as a vaccine," says virologist Dr Shahid Jameel, virologist and CEO, Welcome Trust DBT India Alliance.

"The site says something about making the preparation stable at room temperature but again gives no details. If this is successful it would be very useful. Maintaining cold chain is a big challenge for any vaccine."

He adds, BAT and other tobacco companies would contribute more to public health by not making what they usually make.

Currently, over 100 candidate vaccines are in development right now. Recent estimates suggest it could take at least 12-18 months till we actually have one available for use. But this itself could be record-breaking speed. For instance, the mumps vaccine, which was the fastest ever approved — took four years to develop.

Several experts have indicated that we will need not one, but several vaccines to tackle the coronavirus. It's manufacturing and distribution will be key.

But World Health Organisation (WHO) has also warned that there may be no effective vaccine, and the virus will become something humans will have to learn to live with.

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