With the COVID-19 pandemic persisting, vaccines have become a central component of our fight against the virus. As more and more people receive their doses, questions and concerns naturally arise. Are these vaccines safe? What about potential side effects? How were they developed so quickly? In this article, we will address some of the most pressing inquiries related to the best COVID-19 vaccine, providing you with the information you need to make informed decisions about your health.
Are there any dangers or safety concerns associated with the COVID vaccines?
In order to identify any potential risks or safety concerns, the CDC and FDA closely monitor the COVID-19 vaccines for any possible safety issues. As a result of this ongoing work, there have been revised recommendations for the Johnson & Johnson vaccine, as well as information regarding rare side effects linked to the Pfizer and Moderna vaccines.
- Johnson & Johnson/Janssen. In December 2021, the CDC updated its recommendations, stating that either of the two mRNA vaccines is preferred over the Johnson & Johnson (J&J) COVID-19 vaccine. The CDC explained that the Pfizer and Moderna vaccines are preferred due to a higher risk of developing a rare but severe blood clot condition called thrombosis with thrombocytopenia syndrome (TTS) following the administration of the J&J vaccine. The CDC did note that there are specific situations where a J&J vaccine may still be used if the recipient fully understands the risks and benefits associated with it. You can read more about the side effects related to this rare blood clot.
- Pfizer and Moderna. After observing rare occurrences of myocarditis following the second injection of the Pfizer and Moderna COVID-19 vaccines, the CDC released information for the public. Most cases of myocarditis occurred in teenagers and young adults, and the majority of cases were mild and resolved on their own. You can learn more about the side effects associated with myocarditis here.
What if I have received the J&J vaccine? Should I be concerned about blood clots?
If you received the Johnson & Johnson vaccine more than three weeks ago, there is no need to be vigilant for side effects related to blood clots.
However, if you received the J&J vaccine within the last three weeks, it is important to look out for possible symptoms of TTS and seek medical assistance immediately if you experience any of the following:
- Severe or persistent headaches or blurred vision
- Shortness of breath
- Chest pain
- Swelling in the legs
- Persistent abdominal pain
- Easy bruising or tiny blood spots under the skin near the injection site
Is there a possibility of experiencing an allergic reaction to a COVID vaccine?
According to the CDC, individuals with a severe allergy (such as anaphylaxis) to any of the ingredients in the mRNA vaccines should avoid receiving these vaccines. However, the CDC mentions that people with allergies to certain foods, insects, latex, and other common allergens can safely receive the COVID-19 vaccine. Those with a history of severe allergic reactions to injectables or other vaccines should consult with their healthcare provider, who can assess their risk and determine the appropriateness of vaccination.
Essential Information About the COVID-19 Vaccines | Información esencial sobre las vacunas contra el COVID-19
How were the COVID-19 vaccines developed so quickly?
The relatively rapid development of these vaccines should not lead to concerns about safety measures being overlooked. There are several factors that contributed to the quicker development of COVID-19 vaccines compared to other vaccines:
- The technologies used for developing the COVID-19 vaccines were already in progress for years, as part of preparations for outbreaks caused by infectious viruses. The manufacturing processes were ready early on during the pandemic.
- Countries shared genetic information about SARS-CoV-2, the coronavirus responsible for COVID-19, as soon as it became available. This early sharing of genetic information gave vaccine developers a head start in finding a vaccine.
- The testing processes for the vaccines followed all necessary steps, but developers conducted some stages of the process simultaneously to collect data as quickly as possible.
- Governments provided funding to vaccine developers in advance, ensuring they had the necessary resources.
- Some COVID-19 vaccines utilized messenger RNA (mRNA), a new technology that allows for a faster approach compared to traditional vaccine production methods.
- Companies effectively used social media to recruit and enroll study volunteers, and numerous individuals were willing to participate, resulting in a sufficient number of participants to test the COVID-19 vaccines.
- Given the highly contagious and widespread nature of SARS-CoV-2, many vaccine trial participants were exposed to the virus. With a large number of exposures, it took less time to determine the effectiveness of the vaccines.
- Vaccine manufacturers started production ahead of authorization or approval, ensuring that some supplies would be available if authorization was granted.
What measures are taken to ensure the safety of COVID-19 vaccines?
Ensuring safety is always a top priority as federal agencies collaborate with vaccine manufacturers and independent scientific organizations to develop, study, authorize, and approve new vaccines. Here are some of the steps taken for COVID-19 vaccines, as well as other vaccines:
- Meticulous testing. All vaccines undergo clinical trials to assess their safety and effectiveness. For the COVID-19 vaccine, the FDA established stringent safety standards for vaccine developers to meet. This graphic from the National Institutes of Health illustrates the four phases of vaccine development before its release to the public.
- Emergency use authorization. In emergency situations like the COVID-19 pandemic, if a vaccine or medication demonstrates safety and effectiveness, the FDA can grant it emergency use authorization (EUA). An EUA allows for the use of a vaccine, treatment, or medication before formal FDA approval.
- Ongoing monitoring for problems and side effects. Once a vaccine receives EUA and is administered to individuals, the FDA and CDC maintain close surveillance to promptly identify any potential issues. Data on the vaccine's safety record accumulates over time as recipients report their experiences, including any side effects. An important mechanism for reporting adverse events following vaccination is the Vaccine Adverse Event Reporting System.
Demographics of the COVID-19 Vaccine Trials
Do I still need to wear a mask if I get vaccinated?
The CDC continually monitors the spread of COVID-19 and provides recommendations for wearing face masks, regardless of vaccination status.
The CDC also advises that masks and physical distancing be mandatory when visiting a doctor's office, hospital, or long-term care facility, including all Johns Hopkins hospitals, care centers, and offices.
Johns Hopkins Medicine's guidelines regarding mask safety remain unchanged, and we still require everyone to wear masks inside all our facilities.
Can I contract COVID-19 from the vaccine?
It is not possible to contract COVID-19 from any of the vaccines. The COVID-19 vaccines do not contain any live virus or infectious material.
What about the safety of COVID-19 vaccination for diverse groups of people?
Diverse populations were carefully considered by the FDA and other reviewers during the trials. Members of underrepresented minorities, older age groups, and individuals with underlying conditions such as obesity, diabetes, and heart and respiratory conditions were included in the clinical trials for the initial two COVID-19 vaccines.
Mixing Boosters
The following information pertains to individuals who wish to receive different products for their booster vaccine.
Children aged 6 months to 4 years should receive the same product for all primary and booster doses, if eligible.
However, children who have only received 2 doses of Pfizer-BioNTech COVID-19 vaccines should receive the updated Pfizer-BioNTech vaccine as their 3rd dose during the primary series.
Children aged 6 months to 4 years who have completed the 2-dose Moderna primary series should receive an updated Moderna booster.
Children aged 5 who have completed the Pfizer-BioNTech primary series should only receive the updated Pfizer-BioNTech booster.
Children aged 5 who have completed the Moderna primary series can receive a different product for their updated booster than what they received for their primary series.
Individuals aged 6 years and older can receive a different product for their updated booster than what they received for their primary series or previous booster.
Learn more about receiving your vaccine
- Is there a waiting period after recovering from COVID-19 or receiving treatment?
- How can you prepare for vaccination?
- What should you expect during and after vaccination?
Specific recommendations for individuals vaccinated outside the United States depend on the following factors:
- Whether the vaccine(s) received are recognized in the United States as valid vaccinations
- Whether the primary series was completed and, if eligible, a booster dose was received
- Wait for at least 28 days after the last dose of that vaccine, then start the COVID-19 vaccination process anew with an FDA-approved or authorized COVID-19 vaccine.
- If a vaccine has not been approved or authorized by the FDA, limited data may be available or reviewed regarding its safety or effectiveness.
- Receive 1 dose of an accepted single-dose COVID-19 vaccine
- Receive 2 doses of a 2-dose accepted COVID-19 vaccine
Types of Vaccines
The Pfizer and Moderna vaccines employ messenger RNA (mRNA) technology, which delivers genetic code to cells, essentially providing instructions to produce the spike protein found on the SARS-2 virus. The proteins generated using mRNA prompt the immune system to recognize the spike protein as foreign, leading to the development of antibodies and other immune responses to combat it.
In contrast, the J&J vaccine employs a different method to prompt human cells to produce the SARS-2 spike protein, triggering an immune response. This vaccine is classified as a viral vectored vaccine. The harmless adenovirus, a member of a large virus family that includes some common cold-causing viruses, has been genetically modified to carry the genetic code for the SARS-2 spike protein. Once inside cells, this code is utilized to produce spike proteins. J&J utilized the same approach to develop an authorized Ebola vaccine as well, as approved by the European Medicines Agency.
Number of vaccine doses per injection
The initial course of both the Moderna and Pfizer vaccines consists of two injections: an initial dose for priming, followed by a booster shot. The time interval between doses for Moderna is 28 days, while for the Pfizer vaccine, it is 21 days.
Each injection of the Pfizer vaccine contains 30 micrograms of the vaccine. On the other hand, Moderna opted for a much higher dose of 100 micrograms. This means that Moderna utilizes slightly over three times the amount of vaccine per person compared to Pfizer. Even though the initial results from Moderna did not seem to justify the significantly larger dose, data suggests that the protection generated by Moderna's vaccine declines at a slower rate than Pfizer's. This has led some experts to speculate that the higher dose may be partially responsible for this trend.
As previously mentioned, the J&J vaccine is administered as a single injection. However, the company has also conducted trials with a two-dose regimen, spaced 57 days apart. The results of this trial, involving 30,000 participants, were presented during an FDA advisory committee meeting on October 15, as part of J&J's application for emergency use authorization (EUA) for their booster dose. (More details on this will be provided later on.)
Longevity of protection
Concerns regarding waning immunity have prompted several countries to offer booster shots to their citizens, despite the World Health Organization's Director-General, Tedros Adhanom Ghebreyesus, calling for a moratorium on boosters until 2022 in order to prioritize first doses for low-income nations.
What appears to be occurring is that as time passes after vaccination, protection against all Covid infections begins to decline. Instances of breakthrough cases, which are mostly mild, have started to rise. Pfizer recipients have experienced the most significant decrease in protection. Data from the extensive Kaiser Permanente health system in Southern California indicates that the decline is most noticeable against the Delta variant, the predominant strain of SARS-CoV-2 in the United States. However, protection has also diminished against other variants.
All three vaccines continue to provide substantial protection against severe illness, although the Biden administration is concerned that this defense may weaken without boosters.
At this stage, a crucial question is whether booster shots will reinforce protection in a more sustainable manner or if these additional doses mark the beginning of a regular booster shot campaign.
Vaccine usage
The initial vaccine to be authorized in the United States remains the most widely used among the vaccines available here. As of January 10, out of over 519 million vaccine doses administered, 58% were Pfizer shots, 38% were Moderna jabs, and 3.4% were manufactured by J&J.
Even though the FDA and CDC have stated that individuals have the choice of receiving any of the three vaccines for boosters, most people have opted to receive the same vaccine they received initially. Among those who received the Pfizer vaccine as their primary series, 93% selected the Pfizer vaccine for their booster dose. Similarly, 92.5% of individuals who received the Moderna vaccine as their primary series went on to choose the Moderna booster.
However, the J&J vaccine, which only requires a single dose, is an exception. Out of the 3.9 million people who received J&J as their primary vaccine and received a booster by January 10, only 33% stuck with J&J for their booster, while the remaining 67% opted for one of the mRNA vaccines.
Safety for pregnant, lactating, and planning individuals
During the initial stages of the Covid vaccine rollout, there was a lack of data to determine the safety of the vaccines for pregnant or lactating individuals. However, after conducting several studies, experts have concluded that the vaccines are safe during pregnancy and lactation. Furthermore, these two groups are strongly encouraged to receive the vaccines. For example, a study published in the New England Journal of Medicine examined the safety of the Pfizer and Moderna vaccines in pregnant and lactating individuals.
The CDC and the American College of Obstetricians and Gynecologists recommend that individuals who are pregnant or lactating should receive the vaccine due to the risks posed by Covid infection.
There are various rumors circulating that being vaccinated against Covid could negatively impact a person's fertility. Recently, ESPN football reporter Allison Williams announced her resignation from the network, which has a vaccine mandate, citing her desire to have another child.
However, there is no evidence to suggest that receiving the Covid vaccine poses a threat to fertility. In fact, a study published in September compared pregnancy rates among patients undergoing in vitro fertilization. The study aimed to determine if there were any differences among individuals who were vaccinated, had Covid antibodies from a previous infection, or had neither. The authors reported that "the current study failed to identify a difference in implantation or pregnancy rates between women with documented seropositivity to the spike protein and women without seropositivity.
In the midst of the ongoing pandemic, the availability and efficacy of various COVID vaccines have been a topic of immense interest and concern. Many questions have been raised around the risks, safety measures, and potential side effects associated with these vaccines. However, it is important to note that extensive research, testing, and thorough regulatory scrutiny have contributed to the development of these vaccines. Rigorous protocols and guidelines have been followed to ensure their safety and effectiveness. While concerns about blood clots and allergic reactions have sparked worry, it is essential to remember that the benefits of vaccination overwhelmingly outweigh the possible risks. Moreover, wearing masks and practicing other preventive measures are still crucial even after being vaccinated. As the global vaccination effort gains momentum, the focus must now shift towards increasing vaccine uptake, especially in high-risk populations, and addressing concerns related to pregnancy and lactation. With ongoing scientific advancements and continuous monitoring, the world remains steadfast in its commitment to safeguarding public health and combating the COVID-19 pandemic.
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