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Opinions of Sunday, 22 November 2020

Columnist: Dr Paul C Adjei

COVID-19 vaccine: ‘Help is on the way, but help is not yet here’

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I have often wondered how history would judge our generation’s wimpy and incompetent handling of the COVID-19 pandemic. I wondered if humanity had forgotten that life on earth had always been a struggle. Whether our “cushy” modern existence has caused mankind to lose our collective fighting spirit, mental fortitude and the resilience to face life’s harshest realities. All generations of mankind throughout history have lived through their versions of global calamities – the plague-tuberculosis-syphilis-leprosy epidemics that characterized the Dark- and Middle-Ages, the 1918 influenza pandemic, world wars and so forth.

However, ours is the only generation to possess the know-how to wipe out such a pandemic. Compared with our ancestors, modern humankind has the least to complain about. Well, it turns out our ancestors could very well be proud of us for the unprecedented efforts that went into the rapid development of Covid-19 vaccines, with pharmaceutical companies, academic researchers, and government agencies working to compress into several months a process that typically requires at least several years.

And so, it came to pass that against all odds, not one, but two COVID-19 vaccines have duly arrived. For now, I will spare you the “gory” details of the mechanistic processes and address only the implications and “matters arising”. In the past two weeks, two pharmaceutical companies, Pfizer and Moderna announced hugely successful trials of their Covid-19 vaccines.

In reality, though, what does the discovery of these vaccines mean for the COVID-19 fight?

There is an almost universal assumption that once a vaccine is created and approved, then everyone is healthy, and everything is “fine”. But the operational challenges from here on demand sober reflection; especially where approximately 50% – 70% of the 7.8 billion people on earth must be “urgently” vaccinated in a short period to achieve that Holy Grail of herd immunity. Getting a vaccine through clinical trials and approved by regulatory agencies (FDA in the USA and its equivalents worldwide) is a tedious, expensive, and time-consuming process (bear in mind that both vaccines are yet to be submitted to the FDA for approval).

But it is not the finish line for a COVID-19 immunisation campaign. It’s just one of the first hurdles. To prepare for the rapid sprint to the finish line, COVID-19 vaccine production is already underway. The idea is that once a vaccine does get the green light from the FDA and other regulatory agencies, doses are ready to roll out right away. “Operation Warp Speed”, the $10 billion US government vaccine development effort, is aiming to have 300 million doses of a Covid-19 vaccine produced by January 2021.

This in itself is an almost impossible undertaking as Pfizer has promised only 50 million doses of their vaccine globally and 25 million for the USA by December 31 while Moderna is still working on final estimates. Divide the number of doses by two to get the number of people actually vaccinated (two doses per person).

This is woefully inadequate even for the initial “high priority persons” group – frontline workers, high-risk patients and leaders of society. This timeline might even become severely altered based on how the USA post-election events play out including transition from President Trump to President-elect Biden. It is to be noted that these timelines do not necessarily apply to developing countries. They apply mainly to the USA, the EU, Canada and Australia.

It is well known that these countries placed orders months ago, even before the idea of a COVID-19 vaccine took hold. What might save the developing world in the end, is the fear by these western powers that neglecting developing countries might bring COVID right back to their doorsteps.

That then begs the question of how developing countries like Ghana would be impacted. In normal times, vaccines would be rushed to developing countries because the world would be trying to eradicate diseases that either have long since disappeared from the developed countries, like polio or began in developing countries, like Ebola. These, however, are not normal times, unfortunately.

It so happened that the developed world took a bigger hit from COVID-19 than developing countries – or so we are made to believe – even though there is mounting evidence suggesting that the lower disease burden might be due to underreporting and or underdiagnosis. The reason is immaterial in any case because the implication, in either case, is the same – vaccines preferentially going to the developed world at the expense of the developing.

The next hurdle is the maintenance of “cold chain” during vaccine transportation. From production floors, vaccines have to go to and from shipping facilities, to trucks, to hospitals/clinics/pharmacies, and, eventually, into human beings — all while being maintained within narrow, specific temperature ranges. These series of handoffs under strict temperature controls is known as the cold chain. It is this chain — between the manufacturer and the human body — that represents one of the biggest challenges of the COVID-19 vaccine distribution effort (especially in developing countries). Each step could potentially become a weak link.

Every time a vaccine moves, it introduces yet another risk. Bad weather can delay delivery flights. Freezers can fail on refrigerator trucks. Vaccine shipping containers can end up stuck on the tarmac. Coolers can leak. Even opening freezers repeatedly to move things in and out can harm vaccines stored inside. Every breach in temperature control degrades the vaccine. Every time the vaccine moves, the chances of this happening increase, so health officials need to plan carefully to ensure the absolute minimum amount of movement. For the new COVID-19 vaccines, these logistical challenges are multiplied by the fact that the Pfizer vaccine, requires some of the coldest temperatures of any vaccine under consideration: minus 70 degrees Celsius (minus 94 degrees Fahrenheit) or lower.

Moderna’s vaccine requires long-term storage at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) and is stable for 30 days between 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit). Unless the WHO and organizations like the Gates Foundation step in, vaccines might not even make it Africa in the foreseeable future especially given these unprecedented cold chain requirements.

With regards to “matters arising”, while no serious adverse events were noted during the trials, several important questions remain unanswered. One key unanswered question is how long the vaccine’s effectiveness will last for after the two doses and whether booster doses would be required and when.

The second question relates to details about the nature of the infections the vaccine can protect against — whether they are mostly mild cases of COVID-19 or also include significant numbers of moderate and severe cases.

Finally, it is unclear whether the vaccine can prevent people who show no or only very mild symptoms of COVID-19 from spreading the coronavirus. A transmission-blocking vaccine could accelerate the end of the pandemic. This is by no means saying that blocking transmission is a requirement for vaccine effectiveness. It simply means that we are going to have to continue social distancing-masking until herd immunity is achieved if the virus does not block transmission. For example, the influenza vaccine prevents the vaccinated from getting sick after infection with the influenza virus but not the transmission of the virus from the infected (vaccinated) person to another person. That is why some masking is still required during the influenza season.

The next big issue has to do with the question of safety. Opinions appear almost unanimous that the speed of development might render these COVID-19 vaccines unsafe. By no means am I declaring the vaccines safe. But in the unlikely event that these vaccines fail the safety test, it would not be because of the speed of discovery.

While we are all entitled to our opinions, I think it says a lot about human nature that in an age where unimaginable technological advances have led to supernatural speeds in all things human – instantaneous messaging systems across space and time, rockets that could reach Ghana in an hour from the USA, Amazon orders that are delivered in a day – our best reaction to a vaccine delivered at high speed using up-to-the-minute technological advancements, is to discredit it based on the speed of discovery!

It says a lot about the state of humanity that we are all too happy to accept technology for all things social media but not for lifesaving vaccine breakthroughs. Vaccine development took years because the steps were implemented sequentially from clinical testing of vaccine candidates to manufacturing. To accelerate the process, COVID-19 vaccine manufacturing occurred concurrently with testing. The idea was that once a molecule passed from “candidate” to “vaccine”, doses would be ready to roll out right away.

This was the operating principle of the aforementioned Operation Warp Speed. This is the greatest vaccine breakthrough since the fathers of immunization/vaccination/immunology, Edward Jenner (17 May 1749 – 26 January 1823) and Louis Pasteur (December 27, 1822 – September 28, 1895), graced science with their geniuses. Even if these initial COVID-19 vaccines turn out to be disappointments, modern vaccine development technology would look back on these days as the rebirth of Jenner and Pasteur.

The other reason often cited for the safety concerns is “big pharma” leading the charge. Again, in an age where the public-private-science-technology partnership is the norm, I do not think that should factor in our evaluation of these vaccines. SpaceX rockets (private) have just transported NASA Astronauts (a government agency) to the International Space Station for the second time in a month. Moreover, all vaccines, medicines and supplements currently in use come from “big pharma”.

Legitimate and valid are the questions. Would the vaccines work? Would they be safe? Would they check all the boxes?

Only time will tell.

In conclusion, there is good news, there is bad news and then there is the conundrum. The good news is that COVID-19 vaccines have been discovered – fingers crossed! The bad news is that the vaccines are not widely available just yet and would not be for at least several months. The conundrum? Managing to survive until the vaccine actually arrives! Yes, to receive the vaccines, you first must be alive!

Again, to quote Dr Anthony Fauci: “help is on the way, but help is not yet here”!