Many of our travelers have asked us what the vaccines are going to mean for the travel world, and this question is also often packed with uncertainty about the vaccines themselves. Since one of our frequent travelers was Vice President of Pharmacovigilance and Patient Safety for a Major International Pharmaceutical Company, we figured he would be the perfect person to help us understand the issues and gain insight into what this all means.

Jim has been on a number of Zoom Vacations tours, and he was kind enough to share his thoughts on Covid-19, the vaccines, staying safe, and how the vaccines may impact travel.

DISCLAIMER: THIS INTERVIEW REPRESENTS JIM’S PERSONAL OPINION. IT IS NOT INTENDED AS DEFINITIVE MEDICAL ADVICE OR TO SUGGEST WHETHER YOU SHOULD OR SHOULD NOT TAKE ANY OF THE COVID 19 VACCINES. ALTHOUGH HE HAS TRIED TO BE ACCURATE IN HIS ANSWERS TO OUR QUESTIONS, NONE OF THE INFORMATION IS REPRESENTED AS VERIFIED, FACTUAL OR ACCURATE FOR THE PURPOSES OF MEDICAL DECISION MAKING. AS MORE INFORMATION ABOUT THE VIRUS AND VACCINE BECOMES AVAILABLE, MEDICAL PROFESSIONAL’S OPINIONS AND RECOMMENDATIONS WILL CHANGE.

THIS OPINION IS ONLY PROVIDED IN AN EFFORT TO HELP READERS UNDERSTAND A VERY COMPLEX AND CONFUSING MEDICAL TOPIC. THE HOPE IS THAT A BETTER UNDERSTANDING OF THE TOPIC WILL ENCOURAGE BETTER DISCUSSIONS BETWEEN YOU AND YOUR PERSONAL PHYSICIAN. AS SUCH YOU TOGETHER MAY MAKE BETTER DECISIONS ABOUT WHETHER THE VACCINES MAYBE RIGHT FOR YOU.

IT IS IMPORTANT TO UNDERSTAND THAT A VACCINE IS A TYPE OF MEDICINE WHICH IS DESIGNED TO PREVENT A DISEASE. ALL MEDICINES (INCLUDING VACCINES) HAVE BOTH BENEFITS AND RISKS (SOMETIMES CALLED SIDE EFFECTS). THESE BENEFITS AND RISKS MAY BE IMPACTED BY EACH INDIVIDUAL’S UNIQUE MEDICAL CONDITION. FOR THIS REASON, YOUR DECISION TO TAKE OR NOT TAKE THE COVID 19 VACCINES AND RELATED ISSUES SHOULD ALWAYS BE BASED ON DISCUSSIONS WITH YOUR OWN PHYSICIAN (OR OTHER RELEVANT HEALTHCARE PROFESSIONALS WHO UNDERSTAND YOUR SPECIFIC HEALTH BACKGROUND) AND NOT ON THIS OR OTHER NON EXPERT OPINION. HE DOES NOT REPRESENT HIMSELF AS AN EXPERT ON THESE VACCINES OR ON FDA DECISIONS, PROCESSES, RULES, OR REGULATIONS.

Zoom: What was your title, and primary function(s) of your job?

Jim: I was the Vice President of Pharmacovigilance and Patient Safety for a Major International Pharmaceutical Company. I was essentially the physician responsible for overseeing the safety of all the company’s drugs and devices both in development and post approval at my company. All drugs and devices have risks (side effects) and benefits (efficacy). My group’s goal was to help identify and minimize the risks of each drug relative to the benefits. We used public health techniques to do this.

Zoom: What are vaccines and how do they protect us?

Jim: All vaccines use some piece of the virus (called an antigen) to “prepare” the patient’s immune system to fight off a future infection when a patient encounters the real virus. Think of it like when a manufacturer decides to make a new product. The company has to go out and hire workers to make the product, test it, buy and stock the supplies, and set up a manufacturing line. All this “preparation” takes time before you can make the first product. Once the company prepares, they can then manufacture the product much more quickly when the next order comes in. Similarly a vaccine helps the immune system to do the “preparation”, such that when a first exposure to virus occurs, the body is quick to supply a tested immune response and kill the virus before it can do damage (cause infection).

Zoom: Can one catch Covid-19 from these vaccines?

Jim: No. These vaccines do not contain the complete live virus and therefore are not infectious.

Zoom: What is the difference between the Pfizer and Moderna vaccines?

Jim: Both of these vaccines use a small non-infectious fragment of the virus (called an antigen) to prepare the immune system as described above. They both do so by using the body’s own cells and genetic material called messenger RNA (mRNA ), carried in oil particles to produce the fragments rather than producing the fragments from weakened virus outside the bodies and injecting it. So these two vaccines are actually very similar although use different genetic fragments for production.

They also have a very similar level of efficacy, in the mid 90s. This means that for every 100 people who have been vaccinated, on average 95 will likely not get the symptomatic Covid infection. Both vaccines have very similar safety profile, based on available data from clinical trials. They both require two separate doses to achieve maximum protection.
The Pfizer vaccine has very strict storage temperature requirements which makes it somewhat harder to distribute.

Zoom: How is the Johnson and Johnson vaccine different from Pfizer or Moderna?

Jim: This vaccine (as of Jan 20, 2021) has not yet been authorized by the FDA for use. As such, full data has not been released about the level of efficacy or safety. It is expected based on the ongoing studies, that this vaccine will only require a one time shot to achieve maximum efficacy. This vaccine is made with more conventional vaccine production methods as described above and does not use messenger RNA. Data is expected by around end of January or early February.

Zoom: Are the future “protein-based” vaccines more effective than the mRNA vaccines that have been authorized, or is “94% efficacy rate” good enough?

Jim: This is a complex question. The FDA (and counterpart agencies in other countries) determine “good enough” by asking the Drug Company (PFIZER, MODERNA, ETC) to prove a certain level of efficacy and safety in clinical trials (levels are defined prior to the start of the trials). Since each clinical trial is different you can’t compare two different vaccines unless you study both in the same trial and with the intent to compare their efficacy and/or safety directly. This has not been done between any of the current covid vaccines. It’s possible this comparison will never be done due to complex process issues which make it difficult. You should judge each vaccine based on its own merits.

Zoom: What do you think is causing the fear some people have about getting the vaccine?

Jim: People’s reasons for fear about vaccines are varied. There has been a lot of misinformation about these vaccines and vaccines in general that may likely contribute to fear. I also hear people say that because the vaccines were developed faster than is traditional, that corners must have been cut and therefore the drugs may not be safe. There are many reason why these drugs were developed/authorized so quickly, but no evidence has been provided to suggest corners were cut. The vaccines will continue to be monitored by the FDA and other international regulators beyond their authorization.

Both vaccines were given to very large numbers of test subjects in clinical trials, each of whom were then monitored for efficacy (did they develop a covid 19 infection after two doses?) and any side effects were recorded regardless of if it was caused by the vaccine. An equal number of people were given a Placebo (not the vaccine) and they were also followed for efficacy and side effects.The two groups were compared. All data was reviewed by experts who are external to the both the companies (Pfizer and Moderna), and the FDA, and deemed it to be of high quality before submission to FDA.

Statistically many more Covid infections occurred in the placebo (non vaccine group) than in the vaccine group. This efficacy for both was deemed to be in the mid 90’s. This is a relatively high level efficacy for a vaccine.

While I have no inside information regarding the development process of these two vaccines, the FDA published a complete document about the efficacy and safety of each of the two currently authorized drugs. In addition the FDA held a full day meeting for each drug, where independent advisors reviewed the data, discussed it, and were asked to vote on whether the drug’s available data justify that it be authorized for human use. They voted affirmatively for both drugs. The FDA took this into account with their own scientific review before authorizing the drugs for use. Additionally, several other reputable counterparts to the FDA in other countries have looked at the same data and arrived at similar opinions.

Every drug (including these vaccines) has side effects. Some are mild, and some are more serious. The known safety of every drug evolves over the life of the drug and can be impacted by many factors. The short-term safety (side effects seen in clinical trials) collected during initial two months of trials was considered by FDA and the Advisory Committee to be minimal when compared to the benefits of receiving the vaccine. Some people are worried about the long term side effects that could occur. While there was no evidence to suggest this might be the case, the FDA and other International Safety agencies traditionally put extensive processes in place to monitor this possibility.

Some people worry that since these will be the first vaccines using mRNA methods of production, there will be unknown issues. The current studies can’t answer that question specifically because they have been short so far. It is important to know this methodology using mRNA has been used to treat other diseases such as cancers, in which there is a better understanding of the safety. Manufacturers explain that the mRNA is cleared from the body shortly after it is introduced by vaccination and there have been no major safety concerns in short term data or in other non vaccine drugs using this technology. Only long term use in large populations can answer this question definitively.

Zoom: So what is the validity of those fears?

Jim: We learn new things about the safety and efficacy of every drug (including vaccines) over the life of the drug. This is normal as not everything can be learned during initial clinical trials. These vaccines are no different. The FDA and their counterparts in other countries, as well as manufacturers have rigorous requirements to monitor and test drugs well beyond their initial trials /authorizations and to use this information to work with physicians to maximize safety and efficacy on an ongoing basis.

Zoom: What are a pharmaceutical’s primary concerns when developing a vaccine?

Jim: I don’t have any inside information about the development of these specific vaccines, but in general, each drug (vaccine) has its own potential safety and efficacy concerns depending on the disease they treat, the populations likely to use the drug, and the make-up of the specific drug. There are very rigorous processes mandated to evaluate these.

Zoom: Will the FDA and other International regulators continue to monitor the safety of the vaccines

Jim: There are very comprehensive requirements for both the pharmaceutical companies and the FDA (and their counterparts in other countries) to continue monitoring and investigating , very closely any perceived side effects that might occur in those vaccinated. This is true of all new drugs, but here it is enhanced further because these vaccines have been authorized for use under an EUA (Emergency Use Authorization) which brings additional requirements.

Zoom: Of the vaccines requiring two shots, does one shot offer any protection? How much?

Jim: There are suggestions that the initial dose (followed by appropriate time for an immune response) may offer some protection in some recipients before the second shot is administered. However, the studies did not definitively confirm this, nor was the data sufficient to know how much protection was conferred or how long it persists if conferred at all. Some recent data from Israel suggests that a single dose may not confer effective protection longterm. Current recommendations are that you take the vaccine as studied (two doses) separated by a specified amount of time, until public health officials say otherwise.

Zoom: We have heard there are various versions or mutations of the virus. How would you respond to someone who is afraid that the vaccine won’t protect them against the mutations or versions. Am I wasting my time if I get the vaccine now?

Jim: There are several variants of the virus (UK, South Africa, etc). As each variant is identified, public health officials, manufacturers of vaccines, and regulators are investigating if current vaccines are effective. It is believed that current vaccines are still likely to be effective for most known variations of the virus. This could change, and while your decision to take the vaccine is best made in consultation with your physician, it’s important to understand that mutations occur as viruses spread. Decreasing the spread may ultimately help to slow mutations and (variants of virus) and therefore people should not feel it’s a waste to get it. Some viruses mutate and require vaccines to be monitored over time. We will only likely know if this is true about Covid once a large number of the population is vaccinated.

Zoom: Do you know how long it takes for the vaccine to take affect?

Jim: Each person’s immune response to a vaccine is a little different but recommendations are that you take the vaccine (two doses as prescribed) and wait about one month after the second dose to achieve full benefit of the vaccines. There may be situations where your immune response may be less effective and therefore your physician can talk more about your specific situation.

It is very important to know that various health leaders/agencies recommend that you still follow all masking, hand-washing and social distancing requirements even after you have received the vaccine. This may be required for a long time.

Zoom: Why do I have to continue to follow social distancing and masking guidelines after I have had the vaccine.

Jim: The studies do not yet confirm that the vaccine can prevent a person from carrying the virus and spreading it even if they are not sick themselves. Additionally since the vaccine is not 100% effective some people will still get the Covid infection.

Zoom: Have you been more impressed or unimpressed at how these vaccines were created?

Jim: Vaccines typically take many years to develop. I am impressed by the speed with which each of these vaccines were developed and released for use while apparently providing robust efficacy and safety data. There are many reasons for this, not the least of which is a herculean and selfless effort by Pharmaceutical Company Staff and Government Regulators.

Zoom: Do you have any insight into how the vaccines will affect life in other countries, and how it will affect travel in general?

Jim: Many countries are developing their own unique vaccines. Each will have its own efficacy and safety profile. Other countries will depend on getting doses of the Moderna, Pfizer or other Globally developed vaccines. It is important that herd immunity is developed around the globe by vaccinating as many people as possible around the globe with an effective vaccine. If a large part of the world remains unvaccinated and the virus continues to spread uncontrolled, infecting large numbers of people, the risks of mutation of the virus and vaccine resistance goes up.

It’s hard to predict how travel will be impacted by the vaccine but one would expect increasing confidence. While people will likely feel more comfortable traveling after they have received full vaccination, Health officials will likely recommend they still follow social distancing, masking, and hand washing precautions. You should again discuss your specific health situation with your physician if you have concerns about travel after you are fully vaccinated. In addition some travel providers may mandate vaccines before you can travel with them. At least one major cruise line has already said this is the case.

Zoom: I have heard there are things we don’t know yet about these vaccines. What are they?

Jim: Drug (vaccine) makers can only claim things they have scientifically proven to be true. Sometimes studies may suggest certain things but may not have scientifically proven them or the number of people in studies is not enough to prove a particular thing. For example if the vaccine is not tested in Children under 18 then they cannot assume the vaccine works in them in the same way as it does in the older tested population. If a vaccine is only tested for three months, then a company cannot claim that you have longterm immunity, even though that may be the belief, until longterm data is obtained that confirms this belief.

For these vaccines there are many things we still need to understand. They include but are not limited to: Do these vaccines have differing effectiveness or safety issues in certain populations that weren’t specifically studied? These might include extremely old patients, pregnant women, people with poor immunity, children, minorities, or other ethnic populations. We also don’t know how long the immunity lasts in fully vaccinated people or if those who get infected despite the taking vaccine will be less ill or be able to spread the virus. Long term safety, although not thought to be a major concern, is still not fully defined, since only a few months of experience are available. It is not uncommon that we what we know about the safety and efficacy of a drug (vaccine) after initial approval/authorization changes based on new data gathered in real world use.

Zoom: Will you take the vaccine when it is offered?

Jim: I absolutely plan to take one of the vaccines as soon as it’s available to me. Each person should make this decision based on their personal medical history and based on consultation as appropriate with their physician.

Zoom: Things seem to change often. Where can we get accurate information?

Jim: The CDC maintains a good Vaccine FAQ, as do most states. These are updated regularly as this information changes almost daily.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html