Developing a Covid-19 Vaccine Requires Patience

By Dr. Lynn Webster, PNN Columnist

There is a worldwide race to find a vaccine for the coronavirus. This is a good thing. We all want a vaccine. Everyone is eager to get back to a "new normal" — whatever that will mean — but it's unlikely to happen until we have an effective and safe COVID-19 vaccine.

The pandemic has already cost us more than 700,000 deaths around the world. The sooner we are able to manufacture and distribute a trustworthy vaccine, the better. The company and country that develop an effective vaccine first will likely be credited with saving hundreds of thousands of lives. The company that wins the race may benefit financially. Prestige and power are also at stake.

Researchers who were already working on vaccines for other coronaviruses, such as SARS and MERS, when the pandemic hit have an advantage. Several companies claim to be on the brink of developing a vaccine. Moderna, Pfizer and AstraZeneca are among the pharmaceutical leaders that have fast-tracked the testing process and claim to be almost ready with a vaccine.

However, rushing a vaccine to market could be dangerous. It typically requires many years to develop a new vaccine because it can take weeks for antibodies to emerge -- and even longer for negative side effects to develop. It may take several months to a year for some adverse effects to emerge, so studies require long-term follow-up to track thousands of vaccinated patients.

Many things can go wrong. The Cutter incident in 1955 was a tragic example of this. America's first polio vaccine caused 400,000 cases of polio, paralyzing 200 children and killing 10. The mass effort to immunize children against polio had to be suspended, and laws were put in place to ensure federal regulation of future vaccines.

There have been other vaccine-related fiascos, too. They should teach us all to be cautious and exercise patience with the development of new inoculations — even one as urgently needed as a COVID-19 vaccine.

Russia’s Vaccine 

On August 11, President Vladimir Putin announced that Russia has developed a COVID-19 vaccine. He even claimed that one of his daughters had been vaccinated. However, reports state the vaccine has not been tested beyond some of Russia's elite and military personnel. Results have not been published, and the vaccine has yet to be certified as either effective or safe. 

Last year, more than 800 scientific publications by Russian scientists had to be withdrawn because they contained plagiarized and fraudulent data. This does not bode well for the veracity of Russia's current claims of a vaccine discovery. 

Developing an effective vaccine will take time. However, we should allow as much time as it requires to ensure the vaccine's safety. We cannot cut corners, or people will be harmed. We also need to trust the source of the reported progress. It makes sense to be cautious about accepting anything Russian scientists or its leadership purport to have accomplished. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD

From Russia with Pain

By Pat Anson, Editor

If you’re a pain sufferer who has difficulty getting prescriptions written and filled for opioid pain medication – be glad you don’t live in Russia.

In Russia, even terminally ill cancer patients have trouble getting opioids. And some have committed suicide rather than spend their remaining days in pain.

In February, 11 cancer patients committed suicide in Moscow alone, according to a special report published in Meduza, a web-based Russian media outlet that operates out of Latvia.

“There’s no end to the pain. It won’t stop next morning, or tomorrow, or the day after. It won’t disappear if a tooth is pulled out or if drops of medicine are squeezed into your ear. If you don’t relieve the pain somehow, it eats you up right to the end. It’s absolutely unbearable,” one cancer patient was quoted as saying.

Getting painkillers in Russia is difficult for everyone, whether they have cancer or not. It can take up to three days for adults, according to Meduza, and for children up to 12 days.

Here’s what cancer patients have to do:

First they visit a general practitioner at a clinic, who will assess their pain levels and send them to an oncologist. The oncologist will then write up an assessment and send the patient back to the general practitioner, who will write up a prescription. The head of the clinic must then stamp the prescription, which is only valid for five days.

Clinics typically forward prescriptions to pharmacies at 4 pm – so if a patient doesn’t have a prescription approved by then, they have to wait until the next day.

All of these steps leading to long lines at the clinic, the oncologist and the pharmacy. The final indignity for patients is that they have to return the used containers and packaging from their previous medication to get a new one.

Adding to the stigma is that narcotic painkillers have long been deemed unnecessary in Russia – dating back to Soviet times. Patients who use the drugs are often treated like addicts and doctors who prescribe narcotics are sometimes punished as criminals.

This has led to a thriving black market for painkillers and soaring prices for pain medication that are sold legally. The government is reported to be conducting checks of pharmacies in major cities to protect against price gouging.

Meduza’s story about the suicides sparked a backlash and a heavy-handed attempt by the government to prevent other websites from reporting on poor access to pain medication. The pretext given for the censorship was a 2012 Russian law that prohibits online content advocating suicide and drug use. Any website violating the law can be blocked by the government.

One site was told to delete copy that simply said: "The wife of the deceased explained that her husband suffered from constant pain because of cancer and often said he was tired of being sick."

Moscow's deputy mayor disputed the notion that the suicides were in any way connected to lack of access to painkillers -- claiming that at least seven of the 11 people who killed themselves were unaware they had cancer.

The deputy head of the Russian Federation Council's constitutional law committee disputed the notion that forcing websites to delete information would prevent more suicides.

"The information about the reasons for suicides by cancer sufferers is socially significant in this case,” Senator Konstantin Dobrynin told the state news agency RIA Novosti. “Covering up such information could lead to even more victims."

The World Health Organization ranks Russia 38th out of 43 European countries in access to painkillers, but the problem isn’t unique to Russia.

According to one recent study, pain medications such as morphine and codeine were not widely available or virtually non-existent in a dozen eastern European countries stretching from Poland to Turkey.