Paging Dr. Frischer: COVID vaccine
We are in the midst of a global race to identify and distribute a safe and effective vaccine for the COVID-19 virus. Every day we see new information. It appears that there are three vaccines that may receive emergency FDA approval very soon, with others not far behind. What does this mean for you and me?
Please recognize that this pandemic is far from over. The numbers of ill and dying have never been more terrible. This is an extremely easy disease to spread, and estimates are that only about 10% of us have contracted it so far. That could mean that almost all of us are still vulnerable. We’ve also seen that this disease can recur, and if immunity does not last long, then herd immunity may be a very difficult thing to reach. This makes it even more critical that a safe and effective vaccine is distributed and administered.
Vaccine research has never before been conducted in such a fast and focused manner. Just what are the phases that every new drug must pass through?
Phase I: The drug is given to a small number of healthy people as well as to those who have the disease, in order to identify side effects and to figure out the optimal dose.
Phase II: The drug is given to a larger number of those who have the disease, looking to see whether it works and whether there are side effects that weren’t identified during Phase I.
Phase III: The drug is administered to several hundred or up to 3,000 subjects in a large-scale trial. A similar group of people takes a placebo. This phase normally takes between one and four years.
Phase IV: After the drug is approved for use, it continues to undergo monitoring to confirm that there are no serious or long-term side effects.
Keep in mind that until now, vaccines have taken years, and sometimes decades, to develop. Scientists have telescoped that time frame into mere months, and the current estimate is that we will start distributing the vaccine to frontline personnel in the immediate future, and may have a vaccine available to most of us by the middle of next year; only 12-18 months after this new virus became a clear global threat. That will be a huge scientific accomplishment, and if it happens it will be due to having an international open-ended supply of brilliant minds…and of money.
In addition to skilled scientists and funding, every vaccine must present answers to these critical questions:
· Does it actually protect us from the disease, and if so, for how long do we maintain immunity? Does it actually prevent the disease entirely or just make it a milder case? The Pfizer vaccine requires two doses, and it does make recipients unlikely to get a serious case of the disease. (A mild case is still possible.)
· Can a vaccinated person still spread the disease if they get infected and have minimal or no symptoms? It appears that at least with the Pfizer vaccine, one can still get infected and possibly spread the disease. If that is the case, we may all be wearing masks and physically distancing until COVID-19 is either gone entirely, or diminished to a minimal level.
· Is it safe? I recently got my Shingrex vaccine, which is a wonderful and fairly new vaccine to protect against shingles. Most people experience a mild fever and body aches for some 24 hours. I found those side effects to be a more than acceptable tradeoff when compared to the risk of contracting shingles. It appears that the Pfizer vaccine does cause similar uncomfortable symptoms in about half of the recipients. Uncovering a vaccine’s side effects is one of the key reasons it takes so long to study.
The next hurdle for a new vaccine is mass production and distribution. Are healthcare workers and those at high risk first in line? What impact does wealth make on who gets vaccinated first? How confident will the public be that it is indeed effective and safe? What will the distribution process look like? We don’t yet have clear answers to these questions.
Clearly, not everyone will receive the vaccination. How many will need to be vaccinated in order to achieve herd immunity? Current estimates are 65% to 70%. This would still amount to vaccinating billions of people worldwide!
It is indeed looking like we will have a safe and effective vaccine, starting distribution almost immediately. However, the process of getting most of us vaccinated will take a long time. In the meantime, I urge you to wear your mask, maintain physical distancing, wash your hands frequently, and when you are near anyone outside of your pod, bundle up and stay outdoors.
Dr. Alan Frischer is former chief of staff and former chief of medicine at Downey Regional Medical Center. Write to him in care of this newspaper at 8301 E. Florence Ave., Suite 100, Downey, CA 90240.