CDC Issues COVID-19 Vaccine Guidance for those with Underlying Conditions

Highlights

• The CDC issued new guidance for those certain preexisting health conditions, saying they can receive the COVID-19 vaccine as long as they "have not had a severe allergic reaction to any of the ingredients in the vaccine."
• The guidance includes specific recommendations for those with HIV, weakened immune systems, and autoimmune conditions like Guillain-Barre syndrome and Bell's palsy.
• CDC also stressed the importance of continuing to follow current guidelines for protection against the virus, including mask use and social distancing, even after vaccination.

In the guidance, Centers for Disease Control and Prevention (CDC) said that individuals with underlying medical conditions are at an increased risk of severe illness from the virus that causes COVID-19,” According to the agency, these individuals can receive an mRNA COVID-19 vaccine if they “have not had a severe allergic reaction to any of the ingredients in the vaccine.” The guidance includes specific recommendations for the certain preexisting conditions, and The CDC specifically issued guidance for people with the following conditions:

• HIV and weakened immune systems
• Other autoimmune conditions
• Guillain-Barre syndrome (GBS), which is a "rare, autoimmune disorder in which a person's own immune system damages the nerves," according to the CDC.
• Bell's palsy, which causes sudden and temporary weakness in facial muscles.

People with HIV and weakened immune systems "may receive a COVID-19 vaccine. However, they should be aware of the limited safety data," the CDC said.

The agency stated that there's no information available yet about the safety of the vaccines for people with weakened immune systems. People with HIV were included in clinical trials, but "safety data specific to this group are not yet available at this time.

The guidance also addresses COVID-19 vaccination for individuals with Guillain-Barré syndrome (GBS); a rare but potentially serious autoimmune condition. “With few exceptions, the independent Advisory Committee on Immunization Practices (ACIP) general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines,” the agency says.

Cases of Bell's palsy, a temporary facial paralysis, were reported in people receiving the mRNA COVID-19 vaccine in clinical trials, the FDA said on Dec. 17.

The new CDC guidance says the Food and Drug Administration “does not consider these to be above the rate expected in the general population,” and hasn’t concluded that vaccination caused those cases. Therefore, persons who have previously had Bell's palsy may receive an mRNA COVID-19 vaccine."

For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19.

Guidance also added, people who get vaccinated against COVID-19 still need to follow all current guidance to protect themselves against COVID-19 such as wearing a mask, social distancing and hand hygiene until experts learn more about the protection that COVID-19 vaccines provide under real-life.

Source:

CDC: "COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions"

Opening Safely: What PPE to Wear in Primary Care

As we reopen our offices we are faced with the challenge of determining the best way to do it safely — protecting ourselves, our staff, and our patients. The Infectious Diseases Society of America (IDSA) recently issued an evidence-based guideline to help clinicians in developing a sound approach to this issue, and this guideline, along with recommendations from the Centers for Disease Control and Prevention (CDC), should allow us to move ahead safely.

In this column we focus on selected details of the recommendations from IDSA and the CDC that may be helpful in primary care offices.

Face Masks

Many clinicians have asked whether a physician should use a mask while seeing patients without COVID-19 in the office, and if yes, which type.

The IDSA guideline states that mask usage is imperative for reducing the risk of healthcare workers contracting COVID-19. The evidence is derived from a number of sources, including a retrospective study from Wuhan (China) University that examined two groups of healthcare workers during the outbreak. The first group wore N95 masks and washed their hands frequently, while the second group did not wear masks and washed their hands less frequently.

In the group that took greater actions to protect themselves, none of the 493 staff members contracted COVID-19, compared with 10 of 213 staff members in the other group. The decrease in infection rate occurred in the group that wore masks despite the fact that this group had 733% more exposure to COVID-19 patients.

Further evidence came from a case-control study done in hospitals in Hong Kong during the 2003 SARS-CoV outbreak. This study showed that mask wearing was the most significant intervention for reducing infection, followed by gowning, and then handwashing. These findings make it clear that mask usage is a must for all healthcare providers who may be caring for patients who could have COVID-19.

The guideline also reviews evidence about the use of surgical masks vs N95 masks.

On reviewing indirect evidence from the SARS-CoV epidemic, IDSA found that wearing any mask — surgical or N95 — led to a large reduction in the risk of developing an infection. In this systematic review of five observational studies in healthcare personnel, for those wearing surgical masks, the odds ratio for developing an infection was 0.13 (95% CI, 0.03 - 0.62), and for those wearing N95 masks, the odds ratio was 0.12 (95% CI, 0.06 - 0.26).

There was not a significant difference between risk reductions for those who wore surgical masks and N95 masks, respectively. The IDSA guideline panel recommended "that healthcare personnel caring for patients with suspected or known COVID-19 use either a surgical mask or N95 respirator...as part of appropriate PPE."

Since there is not a significant difference in outcomes between those who use surgical masks and those who use N95 respirators, and the IDSA guideline states either type of mask is considered appropriate when taking care of patients with suspected or known COVID-19, in our opinion, use of surgical masks rather than N95s is sufficient when performing low-risk activities. Such activities include seeing patients who do not have a high likelihood of COVID-19 in the office setting.

The IDSA recommendation also discusses universal masking, defined as both patients and clinicians wearing masks.

The recommendation is supported by the findings of a study in which universal mask usage was used to prevent the spread of H1N1 during the 2009 outbreak. In this study of staff members and patients exposed to H1N1 who all wore masks, only 0.48% of 836 acquired infection. In the same study, not wearing a mask by either the provider or patient increased the risk of infection. Also, in a prospective study of hematopoietic stem cell transplant patients, universal masking caused infection rates to drop from 10.3% to 4.4%.

The IDSA guideline states the following: "There may be some, albeit uncertain, benefit to universal masking in the absence of resource constraints. However, the benefits of universal masking with surgical masks should be weighed against the risk of increasing the PPE burn rate and contextualized to the background COVID-19 prevalence rate for asymptomatic or minimally symptomatic HCPs [healthcare providers] and visitors."

The CDC's guidance statement says the following: "Continued community transmission has increased the number of individuals potentially exposed to and infectious with SARS-CoV-2. Fever and symptom screening have proven to be relatively ineffective in identifying all infected individuals, including HCPs. Symptom screening also will not identify individuals who are infected but otherwise asymptomatic or presymptomatic; additional interventions are needed to limit the unrecognized introduction of SARS-CoV-2 into healthcare settings by these individuals. As part of aggressive source control measures, healthcare facilities should consider implementing policies requiring everyone entering the facility to wear a cloth face covering (if tolerated) while in the building, regardless of symptoms."

It is our opinion, based on the CDC and IDSA recommendations, that both clinicians and patients should be required to wear masks when patients are seen in the office if possible. Many offices have instituted a policy that says, if a patient refuses to wear a mask during an office visit, then the patient will not be seen.

Eye Protection

Many clinicians are uncertain about whether eye protection needs to be used when seeing asymptomatic patients. The IDSA acknowledges that no studies have looked critically at eye protection, but the society also acknowledges that "appropriate personal protective equipment includes, in addition to a mask or respirator, eye protection, gown and gloves."

The CDC recommends that, for healthcare workers located in areas with moderate or higher prevalence of COVID-19, HCPs should wear eye protection in addition to facemasks since they are more likely to encounter asymptomatic individuals with COVID-19.

Gowns and Gloves

Gowns and gloves are recommended as a part of personal protective gear when caring for patients who have COVID-19.

The IDSA guideline is clear in its recommendations, but does not cite evidence for wearing gloves vs not wearing gloves. Furthermore, they state that the evidence is insufficient to recommend double gloves, with the top glove used to take off a personal protective gown, and the inner glove discarded after the gown is removed.

The CDC does not make recommendations for routine use of gloves in the care of patients who do not have COVID-19, even in areas where there may be asymptomatic COVID-19, and recommends standard precautions, specifically practicing hand hygiene before and after patient contact.

The Bottom Line

When seeing patients with COVID-19, N95 masks, goggles or face shields, gowns, and gloves should be used, with hand hygiene routinely practiced before and after seeing patients. For offices seeing patients not suspected of having COVID-19, the IDSA guideline clarifies that there is no statistical difference in acquisition of infection with the use of surgical face masks vs N95 respirators.

According to the CDC recommendations, eye protection in addition to facemasks should be used by HCPs, and masks should be worn by patients. Hand hygiene should be used routinely before and after all patient contact.

With use of these approaches, it should be safe for offices to reopen and see patients.