COVID-19 Vaccine FAQ

Hello Everyone! 

There is a lot to talk about, so before you start reading, pour yourself a cup of hot tea and get comfortable 🙂

I hope you all are well and staying safe as COVID-19 cases and hospitalizations continue to rise.  Without widespread vaccination it would take another three to five years of virus ripping through our communities, disrupting economies and taking millions of lives before we start approaching herd immunity.

Only seven months ago I was thinking a COVID-19 vaccine will not come for years.  On average, it takes about 15 to 20 years, and over $1 billion in cost to go from preclinical trials in animals all the way to the FDA approved vaccines. But as the world was waiting anxiously for any positive news about pandemic that has killed more than 1.5 million people worldwide (over 274,000 people in the US), the scientists around the globe embarked on a path with a goal that nobody has ever achieved – to develop a vaccine within a year. The fact that we will have access to approved vaccines available for large-scale distribution in less than a year is truly unprecedented. The quick progress has been accelerated partly because coronaviruses are a familiar pathogen to modern science, and vaccine work on some of SARS-Cov-2 relatives had already been underway. But the process has also benefited greatly from the investment made by the federal government (Operation Warp Speed), which took the financial risk out of the pharmaceutical companies. The government said it will pay for trials and for mass production at risk, which meant that Pharma could produce vaccines and make millions of doses without knowing whether the vaccine will work or if it will be safe, as the government was willing to throw out these millions of doses if the vaccine was ineffective, or if it wasn’t safe. No pharmaceutical company would ever do that on their own.  Over $10 billion has been spent to conduct clinical research and pre-manufacture doses of the vaccine candidates so that, if the vaccine should get FDA approval, they can start distributing it as quickly as possible.

Because of the speed with which these vaccines have been developed and manufactured, how do we know a COVID-19 vaccine will be safe and effective?

To be declared safe and effective, a COVID-19 vaccine must pass certain tests and standards. Scientific data from research helps to decide if and when new drugs and vaccines can become available to the public. The fundamental way the safety and efficacy of a vaccine is determined is by conducting clinical trials. In a clinical trial, volunteers are divided in two groups. One group is given the vaccine, the other group receives a placebo. Comparisons are made between the groups, and rigorous safety monitoring is conducted by organizations such as the National Academy of Sciences, the National Institutes for Health, and the Food and Drug Administration (FDA) to make sure any side effects or safety issues are identified. Once the clinical trials are completed, scientists and regulatory agencies examine the data to determine the safety and efficacy of the vaccine.

The FDA has been very clear about the conditions under which it would issue an Emergency Use Authorization (EUA) or full approval for any candidate COVID-19 vaccine intended for public use. The FDA process is well established, and considerations are peer-reviewed by external expert panels. Any attempt to sidestep the process would promptly come to public attention and become widely publicized. The FDA leadership has reaffirmed their commitment to have scientific data driving their deliberations and any approval decisions.

Nine vaccine manufacturers (Pfizer and BioNTech, Moderna, Johnson and Johnson, AstraZeneca, Merck, Novavax, GlaxoSmithKline, and Sanofi) issued a rare public pledge that they will not seek FDA approval without comprehensive phase 3 clinical data showing clear results that their vaccine is safe and effective. Aware of potential mistrust, both Pfizer and Moderna have taken the additional step of publishing and making their trial protocols public.

The National Academies of Science provided guidance on conditions required for appropriate vetting of candidate vaccines.

The Association for Professionals in Infection Control and Epidemiology (APIC) issued standards that must be met.

Dr. Anthony Fauci publicly stated that the approval process can be trusted. He will speak out if he has any doubts.

Are the Pfizer and Moderna vaccines effective?

The FDA previously stated that they were likely to approve a vaccine that showed at least 50% efficacy; public health officials were hoping for 60% to 75% efficacy; Both Pfizer and Moderna report that their vaccines showed ~95% efficacy at preventing symptoms of the SARS-CoV-2 virus, including severe disease.

Are the Pfizer and Moderna vaccines safe?

Based on known reports from the clinical trials, neither the Moderna nor the Pfizer vaccine trials have reported any serious safety concerns. Both trials had fully independent safety monitoring boards, and full safety data are being reviewed by the FDA and expert panels. Historically, most serious side effects become apparent early (usually under 4-6 weeks) after being vaccinated. Still, there will be intense short- and long-term monitoring of individuals who receive the vaccine.

The clinical trials were designed to include ~ 25% of underrepresented minorities, ~25% older age groups, and people with various comorbid conditions, such as diabetes, obesity, heart and respiratory conditions. The trials did not include pregnant women or children, but they are currently underway.

The Pfizer and Moderna vaccines are based on mRNA technology, which has not previously been used for a licensed vaccine.  

It is this new technology that has allowed rapid development of the vaccine. However, the platform for mRNA vaccine technology had been years in the making. Many vaccines are based on putting a weakened or inactivated virus into our bodies to trigger an immune response. This is not the mechanism of action of mRNA vaccines. Instead, messenger RNA (mRNA) vaccines teach our cells how to make a protein that triggers an immune response by producing antibodies which will protect us from getting sick when the real virus enters the body.

When will a COVID-19 vaccine be available?

Once the vaccine developers submit their applications to the FDA, it will take about three weeks for FDA regulators to review the materials. If they need to have more information to decide, availability of the vaccine will be pushed back until the FDA is satisfied that the vaccine meets criteria for safety and efficacy. The FDA is meeting on December 10 to consider the Pfizer vaccine and on December 17 to consider the Moderna vaccine. The vaccine will be distributed to all states and territories, who in turn have developed plans to distribute the vaccine. The criteria for vaccine prioritization will be determined by the CDC.

Because there are two vaccines, we may be able to express a preference for which vaccine we would like to receive if there is more than one type available at the time of the vaccination. Both, Pfizer and Moderna vaccines require two doses administered several weeks apart (Pfizer at three weeks apart, and Moderna at four weeks apart). Each vaccine is manufactured differently, even those that use similar technology such as Pfizer and Moderna. Once given one type of vaccine, the second dose should be the same type.

The goal is for the U.S. to reach herd immunity as soon as possible through widespread vaccination. The U.S. has purchased 100 million doses from each company, Pfizer and Moderna. AstraZeneca/Oxford recently completed their vaccine trials. There are several other vaccines that use more conventional technology nearing the end of phase III testing. Both Moderna and Pfizer are ramping up production and we should have plentiful supply by early spring.

What are the side effects of these two vaccines?

Pfizer and Moderna report side effects that include pain at the injection site, fever, muscle aches, fatigue and headaches, mostly lasting about a day or two. The side effects are most likely to be experienced after the second dose for either the Moderna or Pfizer vaccine.

How long does immunity last after the vaccine?

We do not know for certain. For most people with natural infection, detectable antibody wanes after two to four months. However, there is increasing evidence that immunity lasts much longer than initially thought. There have been a few rare cases of individuals seemingly being naturally infected twice, but fortunately this seems to be rare at this time. The SARS-CoV-2 virus appears genetically stable compared with most respiratory viral pathogens. This means it has not mutated in significant ways than other viruses, even within the coronavirus family. However, it is possible that it may yet mutate in the future. The implications for immunity (natural or vaccine derived) are unknown.

Can I be vaccinated if I already had COVID-19?

Yes. The vaccine trials reportedly included people previously infected with the SARS-CoV-2 virus. There were no serious short-term safety issues reported. It is generally thought that natural infection results in better immunity than a vaccine, but this is not always the case. For example, tetanus and HPV vaccines are considered better protection than natural infection.

Can I stop wearing a mask and stop physical distancing practices after the second shot?

No. Generally, it takes 10 to 14 days for the immune system to respond to a vaccine and provide protection against an infectious pathogen. Even with a vaccine that is 95% effective, about 1 in 20 people who receive the vaccine will not become immune. It is also unclear if having effective immunity protects you from carrying the virus and passing it along to others. Until a significant portion of the population becomes immune (either from vaccine or natural infection), the precautions must be followed by everyone. Given the enormous tasks of immunizing a significant part of the population to stop the spread of the virus, it will take months before we can consider cutting back on these basic safety precautions.

This is all for now, and Yes!, I know it’s a lot of information! I hope you will find it useful and helpful.

Stay warm and healthy and safe and in touch!

With all my love,

ZMK