FAQS: COVID-19, Delta Variant, and Vaccines

Updated August 2021

Maven is committed to keeping our members, providers, and team updated with the latest clinical guidance for COVID-19 for women and families. Below are frequently asked questions regarding COVID-19, the Delta variant, and vaccines answered by Maven Chief Medical Officer Dr. Neel Shah, MD, MPP, FACOG. In addition to his role at Maven, Dr. Shah is also an Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School (part-time). He is a globally recognized expert in designing solutions that improve healthcare, and is listed among the “40 smartest people in healthcare” by the Becker’s Hospital Review.

We all imagined a very different fall 2021 and back-to-school experience. Unfortunately, the spread of the Delta variant of COVID continues to put people at risk, especially children too young to be vaccinated and those who have chronic conditions or are immunocompromised. As the landscape evolves, however, so too does clinical research and our ability to understand the virus, the disease, and the best ways to protect the health and safety of ourselves and our families. The goal of this FAQ is to provide up-to-date information and guidance to help you make the best choices for your health and the health of others. 

- Dr. Neel Shah, Chief Medical Officer, Maven Clinic

The latest for pregnant women and people aspiring to become pregnant

‍Should pregnant women get the COVID-19 vaccine? 

Yes, based on the proven safety and effectiveness of the COVID-19 vaccines, as well as the risks of COVID-19 during pregnancy, the Centers for Disease Control (CDC) and the American College of Obstetricians and Gynecologists (ACOG) have advised pregnant women to be vaccinated.  

On August 11, the CDC updated its guidance based on analysis of new data as well as previously collected data assessing the safety of the vaccine for pregnant women. The CDC states: “Combined, these data and the known severe risks of COVID-19 during pregnancy demonstrate that the benefits of receiving a COVID-19 vaccine for pregnant people outweigh any known or potential risks.”

The CDC “encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19.” The American College of Obstetricians and Gynecologists (ACOG) also have issued recommendations:

• ACOG recommends that pregnant individuals be vaccinated against COVID-19.
• ACOG recommends that lactating individuals be vaccinated against COVID-19.

A conversation with a clinician is not required prior to vaccination, as this may cause unnecessary barriers to access.

What are the risks to pregnant women who don’t get the COVID-19 vaccine?  

A study published in the JAMA Medical Journal in August 2021 showed that compared to pregnant women without COVID-19, women with COVID-19 giving birth had higher rates of:

• Respiratory intubation  
• Mechanical ventilation
• Intensive care unit (ICU) admission
• In-hospital mortality
• Preterm birth

Is it safe to get the COVID vaccine when breastfeeding?

Yes, the CDC recommends people who are breastfeeding get the COVID-19 vaccination. While there is limited research data on the effects of the vaccine on milk production or the breastfed baby, the vaccine cannot cause infection in mother or baby, and the vaccines are proven effective in preventing COVID-19. According to the CDC, reports have shown that breastfeeding people who have received the COVID-19 vaccine have antibodies in their breast milk, which could help protect their babies.

What about the Delta variant of the coronavirus? Do the benefits of taking the vaccine for Delta outweigh the risks for pregnant women?

According to the CDC, “available evidence suggests that the COVID-19 vaccines authorized by the Food and Drug Administration (FDA) offer protection against known variants, including the Delta variant, particularly against hospitalization and death.“ The Delta variant, the primary SARS-CoV-2 variant in the U.S. today, is associated with higher rates of transmissibility. It is important for pregnant women and people aspiring to become pregnant to be vaccinated against all variants of COVID-19, including the Delta variant.

What about the safety of the Johnson & Johnson (Janssen Biotech, Inc.) vaccine? Should pregnant women get Pfizer or Moderna instead of the J&J vaccine?

The CDC and FDA have stated that the benefits of the J&J/Janssen COVID-19 vaccine outweigh its known and potential risks. However, for women under 50 years of age, the J&J/Janssen vaccine poses an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). TTS is a rare but serious condition that involves blood clots with low platelets. There are other COVID-19 vaccine options (Moderna, Pfizer) available for pregnant women for which this risk has not been reported or seen.

I heard the vaccine affects fertility. Should I get the COVID-19 vaccine if I’m trying to get pregnant?

There is no evidence that COVID-19 vaccines cause fertility problems in women or men. According to the CDC: “COVID-19 vaccination is recommended for everyone 12 years of age and older, including people who are trying to get pregnant now or might become pregnant in the future, as well as their partners.”

When should I worry about side effects?

First, it’s important to know that there are many common side effects from COVID-19 vaccination, and they are signs that your body is responding appropriately and building protection against the coronavirus. Common vaccine side effects include pain, redness and swelling at the site of the shot; tiredness, headache, muscle pain, chills, nausea and fever. Call your doctor (or contact your Maven care team) If you have a reaction such as a fever that lasts longer than three days, or if you have a serious side effect that prevents you from eating, sleeping or regular daily activities.  

According to the CDC: “Serious side effects that could cause a long-term health problem are extremely unlikely following any vaccination, including COVID-19 vaccination. Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose. For this reason, the FDA required each of the authorized COVID-19 vaccines to be studied for at least two months after the final dose.”

More considerations regarding the vaccine

Should people who got COVID-19 get vaccinated or are they immune to the disease?

The CDC Advisory Committee on Immunization Practices (ACIP) recommends that all individuals be vaccinated regardless of whether they have had COVID previously. Importantly, the vaccine trials did include individuals who had been previously infected. They suggest that the vaccine provides stronger immunity than natural immunity (immunity from having COVID); and we have seen rates of reinfection, so definitely recommend getting vaccinated even if you had COVID.

Are children able to get the COVID vaccine?

The CDC recommends everyone 12 years and older get a COVID-19 vaccination to help protect against COVID-19.  Children 12 years and older are able to get the Pfizer-BioNTech COVID-19 Vaccine. Until a vaccine is available for children between the ages of 2 and 12, they should wear a mask in public spaces and around people they don’t live with.

What about children under age 12? When will a vaccine be available for them?

Until a vaccine is available for children between the ages of 2 and 12, they should wear a mask in public spaces and around people they don’t live with. According to Dr. Anthony Fauci, the country’s top infectious disease expert, there is a “reasonable chance” that COVID-19 vaccines will be available to children under 12 by mid-to-late fall or early winter 2021. Pfizer and Moderna are currently gathering data on the safety, dosage and effectiveness of the vaccines in children.

About the COVID mRNA vaccine

Tell me about the Pfizer vaccine

This vaccine is a two-dose mRNA vaccine with an efficacy rate of 95% after two doses administered three weeks apart. All COVID vaccines are required to go through randomized placebo controlled trials with tens of thousands of participants; the Pfizer vaccine trials had over 43,000 participants. Most common side effects after pain at the injection site recorded by Pfizer were fatigue and headache. The company is expected to make up to 50m doses in 2020 and 1.3b doses in 2021. The safety of the vaccine is monitored for at least 60 days after the second dose before approval is sought.

Tell me about the Moderna vaccine

Data has shown that the vaccine has an efficacy rate of 94.1%. This vaccine requires two injections given 28 days apart. Side effect information is below.

How are vaccines made?

Vaccines are made by administering one of the following: 1) an inactive portion of a virus or an inactive portion of a bacterial toxin; 2) a weakened (live) portion of a virus; or 3) the genetic code (DNA, mRNA or vectored viruses) for part of the virus. The last example is how the Pfizer and Moderna COVID-19 vaccine was made. These vaccines contain “the blueprint” for producing antigens rather than the antigen itself. All provoke the body’s immune response to form antibodies against the virus in question.

What is mRNA? Is it different from DNA? 

mRNA is “messenger” RNA. mRNA is the copy (a complementary sequence) that is made from DNA. Imagine that there is a scribe standing in front of your DNA molecule and the scribe writes down everything DNA says (that’s mRNA)… and then mRNA uses those notes to make a protein. It’s the messenger that takes the code from the DNA to the ribosomes, which are the cell’s protein factories.

How does a mRNA vaccine work?

The mRNA vaccine is a snippet of the outside “spike protein” from the coronavirus, called an S Protein. Because the coronavirus is a mRNA virus, an engineered snippet mRNA gets coated in lipid (fat) and then injected into the deltoid muscle on your upper arm. Once inside your body, your immune system “reads” the information on the snippet. The vaccine tells your cell how to make the harmless piece of spike S protein, and then your cells start making the protein pieces. Next, your immune system recognizes that the proteins don’t “belong” to you, and starts making antibodies to that spike protein. Interestingly, I read, “RNA vaccines are faster and cheaper to produce than traditional vaccines, and a RNA based vaccine is also safer for the patient, as they are not produced using infectious elements.” Importantly, this mRNA vaccine also doesn't enter the cell nucleus.

Vaccine Effectiveness

How did they calculate the effectiveness of preventing COVID after vaccination with the Pfizer vaccine?

• Placebo → 162 persons from the 21,728 that received placebo vaccine got COVID
• Vaccine → 8 persons from the 21,270 that received actual vaccine got COVID
• 95% CI; 90.3 to 97.6

Did the researchers account for demographic differences within the populations they studied?

Yes, confounding variables they adjusted for included: age, sex, race, and comorbidities.

Side effects and limitations

Can the COVID vaccine give you COVID?

No.

What are some possible side effects of the vaccine?

The most common side effect is always going to be pain and redness at the injection site. Yes, from the needle, but also from the vaccine. Some people get a low-grade fever, muscle ache, headache, chills, joint pain or body aches, and side effects were reported with the Pfizer vaccine to be more frequent after the second dose.

From Pfizer:

Among those 18-55 years of age:

• 16% had a fever after the second dose
• 59% fatigue after 1st dose; 52% after second dose
• 52% headache
• 35% chills
• 22% joint pain
• 10% diarrhea
• 83% pain at injection site after 1st dose; 78% after 2nd dose

Among those older than 55 years of age:

• 71% pain at injection site after the first dose; 66% after the 2nd dose
• 11% of those age > 55 had fever
• 51% fatigue
• 39% headache‍

‍Severe systemic events reported in < 2% of recipients of either dose.

From the Moderna trial:

• 9.7% fatigue
• 8.9% muscle aches
• 5.2% joint pain
• 4.5% headache

What are the severe adverse events reported in recipients of the Pfizer vaccine?

• 0.3% reported lymphadenopathy (swollen lymph nodes)
• 4 out of the 21,720 who received vaccine reported adverse events
• Shoulder injury related to vaccine administration
• Right axillary lymphadenopathy
• Ventricular arrhythmia
• Right leg paresthesia 
• 2 vaccine recipients died 
• 1 from arteriosclerosis
• 1 from cardiac arrest
• 4 placebo recipients died
• 2 from unknown
• 1 from hemorrhagic stroke
• 1 from heart attack‍
• Importantly, NO DEATHS were considered by investigators to be related to the vaccine or placebo
• Safety monitoring will continue for 2 years after administration of the second dose of vaccine

What’s the ability of the study to detect adverse effects?

• This study has > 83% probability of detecting at least one adverse event if the incidence is presumed to be 0.01%
• This study is not large enough to detect less common adverse events; for instance, events that happen in only 1 out of 50,000 or 100,000 persons
• All participants were studied for a minimum of 2 months, but some were studied for 3 ½ months
• Investigators will continue to monitor adverse events for at least 2 years

What are the limitations of these vaccine studies?

• No younger adolescents, children and pregnant women were studied 
• Safety and immune response date from adolescents 12-15 will be reported subsequently, as well as data in children and pregnant women and immunocompromised individuals
• The Pfizer vaccine can be stored for up to 5 days at standard refrigerated temperatures
• Very cold temperatures are required for shipping and storage 

Resources

• FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine
• CDC Patient Education Vaccine
• Helpful vaccine and immunity educational videos‍
• New England Journal of Medicine * Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine