Photo: © Dmitry Kurakin/Russian Health Ministry's press service/TASS. Russian vaccine vials. The Sputnik V vaccine is given in two parts.

Noting the common observation that milkmaids were generally immune to smallpox, Dr. Edward Jenner supposed that the pus in the blisters that milkmaids received from cowpox (a disease similar to smallpox, but much less virulent) protected them from smallpox and decided to try to make a vaccine that would prevent smallpox in people other than milkmaids.

At the time, smallpox was such a menace that it killed about 10% of the population, or even 20% in large cities, so it was a pretty serious issue.

On 14 May 1796, Jenner tested his hypothesis by inoculating James Phipps, an eight-year-old boy who was the son of Jenner’s gardener. He scraped pus from cowpox blisters on the hands of Sarah Nelmes, a milkmaid who had caught cowpox from a cow called Blossom.

Jenner inoculated Phipps in both arms that day, subsequently producing in Phipps a fever and some uneasiness, but no full-blown infection. Later, he injected Phipps with smallpox material and no disease followed. The boy appeared to be immune to smallpox.

By present day standards, this testing would not pass muster on ethical grounds, but there were no hard feelings and later in Phipps’ life, Jenner gave him, his wife, and his two children a rent-free lease on a cottage.

Phipps showed up at  Jenner’s funeral on 3 February 1823 to pay his respects, Jenner having died of a stroke, and in 1853 Phipps was buried in St Mary’s church in Berkeley, where he had been baptized, having died at the age of 56, not of smallpox. Jenner was also buried in this same church.

Vladimir Putin announced on Tuesday morning that Russia has registered the world’s first vaccine against coronavirus.  He also revealed that one of his daughters (age unknown)has already been vaccinated.

“In this sense, she took part in the experiment. After the first vaccination, she had a body temperature of 38 degrees Celsius, while the following day it was slightly over 37 degrees Celsius, that’s it. After the second injection, the second vaccination, her temperature also rose a little, and then everything cleared up, she feels good and the [antibody] titers are high”, Putin stated.

The Russian announcement of the Sputnik V vaccine has caused a furore in Western countries, due to a belief that the Russians have not done enough testing to be sure that the vaccine is safe, having given it to no more than “a few hundred people” and not yet conducted an extensive “Phase 3” trial on thousands of people.

The plan now, the Russians say, is to do a Phase 3 trial with 2000 patients. A website for Sputnik V says a phase 3 efficacy trial involving more than 2000 people will begin on 12 August in Russia, the United Arab Emirates, Saudi Arabia, Brazil, and Mexico. Mass production of the vaccine is slated to begin in September.

What is causing such controversy, though, is that Russia has announced that while the Phase 3 trial is going on, the vaccine will also be given to medical personnel and teachers who volunteer to take it.

There are some precedents for development of vaccines and other medicines to be accelerated in cases of an emergency.

For example, the U.S. Emergency Use Authorization (EUA) is an option in pandemic response.

After a declaration of emergency by the Department of Health and Human Services secretary, this program allows for use of an unapproved medical product (or a product that has been approved but not for the specific use applicable to the situation at hand) that is the best available treatment or prevention for the threat in question.

EUAs were issued for antiviral treatments, a respirator, and a PCR diagnostic test during the 2009 A/H1N1 pandemic.

An EUA was also issued for the antimalaria drug hydroxychloroquine, which, despite the enthusiasm of US President Donald Trump, was fairly quickly withdrawn when many doctors found it not effective in the treatment of COVID-19 and that it possibly killed more than it cured.

So the question is how bad an emergency is COVID-19? We don’t want to be quite as reckless as Dr. Edward Jenner, but is it worth the risk giving a relatively untried COVID-19 vaccine to volunteer healthcare workers and teachers who are willing to be guinea pigs? Maybe.

At least, being in Russia, they won’t have to pay for it.