By Dr. Anthony Policastro

In 1998 a vaccine called RotaShield was developed. It was effective against Rotavirus. The virus caused a common type of diarrhea in children. It was added to routine immunizations.

Once it began to be used in many thousands of children, a rare complication appeared.

About 1-2 of every 5,000 children developed an intestinal complication called intussusception. It was rare enough to have not shown up in the vaccine trials.

Since this complication could be fatal and diarrhea was not, the vaccine was discontinued.

In the same year a vaccine against Lyme disease was developed. It was called LYMErix. It was effective against Lyme disease. People with a certain genetic makeup developed arthritis after receiving the vaccine. They sued the manufacturer.

The vaccine was effective. However, the lawsuits cost the manufacturer so much that they decided to stop making it. There was no profit left after lawsuits were paid.

Both of these examples show that vaccine trials do not necessarily show up rare complications.

I have previously discussed the same thing about new medications. Approval of medications and vaccines occur after a number of patients are treated.

However, those trials are not anywhere close to the number of people that will use the medication or vaccine when general approval is given. Rare side effects will then appear.

That is the main reason for the vaccine approval process taking so long. Once a vaccine is developed there are several steps that are followed. The first is to make sure it does not harm animals. This is called pre-clinical testing.

Clinical trials have three phases. In Phase I, the vaccine is tested on several dozen volunteers. This is to look at common side effects or adverse reactions.

In Phase II the numbers increase. In this case the volunteers are selected from the target population. Thus the goal is to make sure this particular population will not have significant issues with the vaccine.

Phase II expands the process even further. Many thousands of people are given the vaccine. Side effects and adverse effects are evaluated. Each phase requires a period of observation after the vaccine is given before moving on to the next phase.

Once approval is given, there is then a need to create the manufacturing process to produce enough of the vaccine. That also takes time. That is why most vaccines take years. Even with the impetus to find a vaccine soon, 12 – 18 months is the best guess for a COVID-19 vaccine.

For COVID, there were 133 different vaccines proposed. Only 10 have been approved for clinical trials by the World Health Organization. China is testing 5. The U.S. is testing 4.

One in the United Kingdom is already at Phase II/III in trials. AstraZeneca has a promised manufacturing capability for 2 billion doses. It is called AZD 1222.

Moderna’s vaccine has gained a lot of press in the U.S. as one that appears promising. They hope to have their clinical trials completed by the end of 2020. They are currently in Phase II trials. It is called mRNA-1273.

Pfizer is working on a vaccine that they think could be ready by the end of October. However, it is still only in Phase I/II trials so that date seems a little unrealistic. Theirs is called BNT162.

The other 7 vaccines are still in Phase I or Phase II trials. There will be a vaccine. It is just not clear when. For the high risk groups it is likely that whatever side effects the vaccine has, they are not likely to be as bad as the risk of death from COVID-19.


There is a misperception that the actions taken related to COVID-19 were aimed at stopping the virus. That is not true. The virus is with us. It is going to stay with us. It will end when we have an effective medication or a vaccine.

The actions were taken to slow the spread of the virus down. That would prevent it from overwhelming our medical resources. That happened in Italy. Resources were stretched thin in New York City.

All of the actions have resulted in a much slower (but inevitable) spread of the virus. The result is that since May 2nd we have only had one day with more than 30,000 new cases in the US. For the last week new cases have ranged from 17,000 to 27,000 daily. The result is that instead of the virus doubling every 48-72 hours as it was at the beginning, that is no longer the case. The latest period of doubling was actually 45 days. That is good.

The national news media does not appear to get it. They run out and look for hot spots. With this kind of infection there will always be areas where there are a lot of cases at once. Reporting on them like they represent the next big thing is not scientific.

For example Sussex County was a hot spot in May. There were 1,435 new cases in a 14 day period. However, it cooled down. In the last 14 days, there have only been 144 new cases total. That is a 90 percent drop. You didn’t see that reported in the national news.