Acuitas: (noun) insight, perception, sharpness.

More Vaccine FAQs

As the vaccines are being administered across the country, we wanted to provide some information on the BioNTech/Pfizer vaccine (which uses our proprietary lipid nanoparticle delivery system). We know that it is important for people to understand the safety and efficacy of the COVID-19 mRNA vaccines. Much of the information in this post happens to be on the BioNTech/Pfizer COMIRNATY® – but it is important to note that for any regulatory agency to provide approval for a vaccine, the organization that developed the vaccine would have had to provide detailed information on its safety and efficacy.

Some of the questions we get asked most frequently are below – with our answers.

Were all of the required safety and efficacy studies completed before the BioNTech/Pfizer vaccine was approved?

BioNTech and Pfizer met or exceeded the safety standards, as set out by regulatory agencies around the world. Further, BioNTech and Pfizer have united with seven other companies that are developing COVID-19 vaccines to confirm their commitment to the safety and well-being of vaccinated individuals, to adhering to high scientific and ethical standards in the conduct of clinical trials and vaccine manufacturing, to only seeking regulatory approval or Emergency Use Authorization after demonstrating the safety and efficacy of the vaccine in a Phase 3 study designed and conducted in accordance with the requirements of expert regulatory authorities such as the FDA, and to providing sufficient supplies and vaccine options to address global access.

The BioNTech/Pfizer COVID-19 vaccine is based on mRNA technology, which codes for a protein made by the novel coronavirus. The vaccine works by allowing the human immune system to recognize this protein so that it can prevent the virus from infecting our cells and causing disease.

A major advantage of mRNA vaccines over conventional vaccines is that they can be developed more rapidly in response to a new virus.

You can see the BioNTech/Pfizer Phase 3 publication of results that was published in the New England Journal of Medicine.

Is the vaccine safe?

Vaccines that receive regulatory approval for use have undergone several phases of clinical trials and that data is submitted to the regulatory agency when requesting approval.

In speaking specifically about the BioNTech/Pfizer COVID-19 vaccine, which Acuitas was involved in the development of, it was shown to be safe in clinical trials conducted prior to seeking regulatory approval. As with all drugs and vaccines, safety will continue to be monitored – even after approval. Vaccines were first developed in 1798 and since then have provided the greatest benefit to human health and well-being of any other medical advancement. Diseases which were common prior to the development of vaccines – such as smallpox, polio, diphtheria, tetanus, typhoid fever and many others – killed hundreds of millions of people globally. Most of these diseases are now almost eliminated in the developed world. This has resulted in substantial reductions in child mortality and longer average lifespans. Most of us have not witnessed the horrors that these diseases caused and so we can find it harder to appreciate how important vaccines really are. Our experience with COVID-19 provides an example of how devastating such diseases can be and we should also recognize that other viruses can be even more dangerous. 

During vaccine trials – do children participate as a part of the study?

While children may not be included in early clinical studies, if the vaccine is intended to provide a clinical benefit to children, they will typically be included once an appropriate safety database is available. BioNTech/Pfizer received regulatory approval to test their COVID-19 vaccine in children 12 years of age and older, and safety data from approximately 100 children 12-15 years of age are included in the Emergency Use Authorization request submitted to the FDA on November 20, 2020.

Should I be vaccinated?

Vaccines can only be fully effective when the vast majority of the population is vaccinated. Vaccination is a social compact, where we jointly agree to protect each other and the most vulnerable among us by preventing transmission of a virus. We strongly encourage everyone to contribute to defeating COVID-19 by getting vaccinated.

What would you say to anti-vaxxers?

We are scientists. We work with facts and with validated scientific principles and data. People who make a personal choice not to get vaccinated put themselves and others at serious risk. Essentially, they are opting out of the social compact that we should all work together to protect the community and the most vulnerable within that community.  

We recommend that anyone who has a concern about vaccination should speak with a doctor and get the facts. There is data to support the safety and efficacy of the COVID-19 vaccines. If there is a reason why certain individuals should not be vaccinated, your doctor will be able to advise you of this.

Should I wait until a later time to get vaccinated to see if it is really safe?

There is data to support the safety and efficacy of the BioNTech/Pfizer vaccine and any other vaccine on the market. An unnecessary delay in getting vaccinated would simply extend the duration of the pandemic. This, in turn, would place continuing pressure on our health care system and health care providers and would delay the recovery of our economy. 

Will a vaccine protect me from COVID-19?

The short answer to this is yes. For example, the clinical data shows that the BioNTech/Pfizer vaccine is 95% effective in preventing COVID-19 infection. In addition, even those relatively few individuals who do contract COVID-19 after vaccination may be protected from experiencing the more serious symptoms and outcomes of the disease. During a press conference given by BioNTech on December 2, 2020, Dr. Ozlem Tureci (Chief Medical Officer) indicated that in their Phase 3 study, only one individual who received the vaccine developed serious disease. At this time, we do not know how long the vaccine will protect us against COVID-19; however, ongoing studies should provide an answer to this question. As with other vaccines, we may need our immune systems to be boosted at some point in the future.

If there is a vaccine, do we still need to keep washing our hands and using hand sanitizer?

It is important to continue with the personal hygiene practices that we have all incorporated into our lives since the pandemic started. Wash your hands often, use hand sanitizer if you cannot wash, and if you are sick – stay home. These are all sensible precautions that we can take to reduce the risk of any viral infection.

What about social distancing?

Once a vaccine has been administered to a majority of the population in your community or social circle, it is expected that we will be able to go back to hugging, indoor dining and other close-contact activities in public that we have had to avoid since the pandemic started.

Do I really need to have both injections of the vaccine?

The short answer to this is yes. The clinical studies conducted by BioNTech and Pfizer showed that the full protective effect of the vaccine requires two injections. A single injection may only provide partial protection.

What are the potential side effects?

Pfizer and BioNTech have indicated that their COVID-19 vaccine has not shown any serious safety concerns to date.

You can see the BioNTech/Pfizer Phase 3 publication of results that was published in the New England Journal of Medicine.

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