The Food and Drug Administration has issued an emergency use authorization for the first COVID-19 vaccine. Americans and people across the world anxiously wait to receive it. Worldwide Brand Medical Director at Novartis, Dr. Paul Mastoridis, spoke with the publisher of the Hellenic News of America, Aphrodite Kotrotsios about the safety and efficacy of the COVID-19 vaccine. Dr. Mastoridis has over 26 years of experience in pharmaceutical research and has a proven track record in therapeutic area strategy, portfolio management, clinical research, drug development, CRO oversight, and global Medical Affairs.
How can the FDA and Pfizer ensure the safety of the COVID-19 vaccine?
The FDA is the Food and Drug Administration and its function is to ensure the safety and efficacy of any medication prior to its approval in the United States. Pfizer must follow all rules and regulations to get a product to market. The studies that have been conducted by Pfizer and Moderna are double-blind placebo-controlled studies which are the best type of studies to conduct to determine safety and efficacy. The FDA approved for emergency use authorization on December 11, 2020, after looking at thousands of data and determined based on the data that Pfizer-BioNTech coronavirus vaccine is both safe and effective. That means the vaccine will be administered in two doses about 3 weeks apart as soon as next week. However, even though the vaccine is safe and 95% effective it still is not devoid of side effects. Some patients can experience side effects such as muscle pain, chills, and headache but this is still better than the alternative.
Even though some trial participants reported flu-like symptoms or coronavirus type symptoms it is impossible to contract the coronavirus from the vaccine because the mRNA vaccines that Pfizer and Moderna make don’t use the live virus. The US has secured 100 million doses of the Pfizer vaccine which is enough to vaccinate 50 million people and 200 million doses of Moderna vaccine which is enough to vaccinate 100 million people with and the option to purchase 300 million more doses from Moderna next year.
How were the vaccines made so fast?
What the public needs to understand is that the speed is a reflection of years of work that went into making vaccines for viruses. They didn’t start from scratch. Creating a vaccine with excellent results from rigorous studies and over 44,000 patients after discovering a never-before-seen disease, is nothing less than a miracle. It is incredible! What normally takes 6 years, the Pharmaceutical industry has reduced it to 8 months. Billions of dollars in company and government funding certainly sped up vaccine development but long before COVID-19 was known, the groundwork was laid by scientists at the National Institute Health (NIH) and at the University of Pennsylvania that were researching coronaviruses responsible for SARS and MERS. These scientists laid the foundation and knowledge for these types of viruses and then pass this on to speed up the process to develop the vaccine.
How do the vaccines work?
COVID-19 stands for coronavirus disease year 2019. SARS-CoV-2 is the name of the virus and COVID-19 is the disease. The virus looks like a circle with spikes. It uses these spikes made of proteins to enter human cells. These so-called spike proteins are targets for vaccines. These vaccines are based on the virus’s genetic makeup for building the spike protein. The vaccine uses messenger RNA, a genetic material that our cells use to make the proteins. To protect the vaccine from our bodies Pfizer and BioNTech wrap the mRNA in oily bubbles made of lipid nanoparticles. Because they are fragile, they need very-low temperatures (-94 degrees F) to remain intact.
Once the vaccine is injected into humans, the vaccine particles bump into other cells, fuse with them and release mRNA. Our own cells read the mRNA sequence and make the spike proteins. Our Immune system then recognizes these spikes, and we go on to develop antibodies against these protein spikes. When we come again in contact with these protein spikes from the virus, we have the antibodies to destroy the virus before it enters our cells to replicate.
Therefore, the virus is eliminated. The Pfizer BioNTech vaccine requires two injections 21 days apart to prime the immune system to fight off the coronavirus. The vaccine started to offer protection after just 10 days after administration of the first dose. The vaccine must be thawed before injection, diluted with saline, and used within 6 hours. On December 2nd, the UK gave approval for the vaccine, on December 9th, Canada gave full approval of Pfizer vaccine and on December 11th, the FDA gave Emergency Use Authorization of the vaccine. Pfizer expects to have 50 million doses by the end of this year and 1.3 Billion doses in 2021. Large scale distribution from Pfizer and Moderna will begin in early spring 2021.
What are the vaccines made up of?
The vaccines are made up of the antigen and in this case, the spike protein mRNA which triggers our immune system to make antibodies to the antigen. The COVID-19 vaccine contains the mRNA genetic code and 4 lipid nanoparticles. The experimental vaccines from Pfizer and Moderna, technically called BNT162b2 and mRNA-1273 respectively, are created synthetically using messenger Ribonucleic acid (or mRNA).
Have any allergic reactions or side effects been reported so far from the clinical trials?
The side effects are flu and COVID-like symptoms such as muscle pain chills and headache. Since patients that have severe allergic reactions were excluded from the studies new evidence shows these people should not take the vaccine. Severe allergic reactions are generally people who take with them Epipen to prevent anaphylaxis.
How quickly, will the first Americans get the shot? How long do you think it will take to vaccinate America?
People should be getting the vaccine as early as next week. By June, the majority of Americans should be vaccinated.
We know that frontline workers and those most vulnerable will receive the vaccine first. Who will be next?
Right now, it is front-line workers, healthcare professionals, nursing home patients, the elderly, and then the rest of Americans. Children should have an approved indication to take the vaccine probably middle to late 2021. Right now, the vaccine is approved for people 16 and older. Each State will be responsible for determining the order of vaccine administration.
How long will it take for the vaccine to slow the spread?
According to the NIH, it could take up to 80% of the population to have coverage in order to reach herd immunity. If all goes well, and many Americas get vaccinated, it will happen around Summer of 2021.
Will the vaccine also protect people who have already experienced COVID-19?
Those that have experience COVID-19 have already developed antibodies to the virus and yes, the vaccine will protect people who have already experienced COVID-19. In people who are mildly ill, their immune protection that prevents a second infection may wane within a few months and those people might benefit more from the vaccine. Time and evidence will tell. We need more data.
How long will the vaccine protect the individual from COVID-19?
That is a good question and difficult to answer because we don’t have a lot of data yet. Recent data suggest long term protection. So far current data suggests longer than 6 months. We won’t know exactly how long immunity lasts without continuing to study those that have recovered from COVID-19.
Is anyone excluded from this vaccine? If so, who and how will they be treated?
Yes, children under the age of 16 and those that have severe allergies needing and (an) Epipen for protection Available data about which patients should not be given the vaccine and when caution is advised, including patients: who are immunocompromised, have a bleeding disorder, and who have a current or previous history of COVID-19 infection.
Once vaccinated, what are the chances someone will experience flu-like symptoms?
Most people are unlikely to have severe allergic reactions to the Pfizer -BioNTech vaccine, doctors and vaccine experts say, but the shots might come with temporary side effects such as fever and muscle pain. Researchers haven’t found serious safety issues with the vaccines, they do come with possible side effects mostly of mild to moderate severity, including fever, fatigue, headache, and arm pain.
Side effects tended to be more frequent after the second dose, according to the analysis. Among those between 18 and 55 years of age, 16% of participants who received the vaccine had a fever after the second dose. Fifty-nine percent reported fatigue, 52% reported headache and 35% reported chills. Thirty-seven percent had muscle pain, 22% reported joint pain and 10% reported diarrhea. Those older than 55 tended to report fewer side effects, according to the analysis.
What are the pluses and minuses of the two-dose vaccine?
Both Pfizer and Moderna have a two-dose vaccine. Pfizer is one dose followed by another 21 days apart. While Moderna is 28 days apart.
Many people are afraid to get vaccinated. What would you say to help ease their minds?
As a researcher for 26 years in the pharmaceutical industry and one that understands how drugs are made and approved and who has looked at the science and data of both Pfizer and Moderna, I would be the first to take the vaccine.
Should people still wear a mask and social distance even if they have received the vaccine?
Yes, but not forever. The clinical trials that deliver these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the virus can spread it even though they don’t experience any symptoms. Researchers will be intensely studying this question as we roll out the coronavirus vaccines. In the meantime, even vaccinated people will need to think of themselves as possible spreaders until we have more data.