Jennifer Gershman, Pharm.D., CPh

 for Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) mRNA COVID-19 vaccines on February 22 to include considerations for an 8 week interval between the first and second doses of the primary series for certain individuals. This guidance discusses that individuals 12 years and older can receive the second dose of the Pfizer-BioNTech vaccine 3-8 weeks after the first. Additionally, the interval for those 18 years and older for Moderna is 4-8 weeks.

This new update stems from data presented this month at the CDC’s Advisory Committee on Immunization Practices (ACIP) 

 about myocarditis and COVID-19 vaccine intervals. Evidence demonstrates that the risk of myocarditis with mRNA vaccines is low. However, the risk is higher in males 12-39 years of age after the second vaccine dose and is seen more with the Moderna vaccine. Myocarditis is inflammation of the heart muscle, and symptoms can include chest pain, shortness of breath, or heart palpitations.

 in teens 12-17 years of age and adults demonstrated that extending intervals longer than 4 weeks may reduce the small risk of myocarditis associated with mRNA vaccines, produce higher antibody responses, and increase vaccine efficacy. However, extending the interval between doses beyond 8 weeks has not been shown to provide any additional benefits.

According to the CDC’s COVID-19 Vaccination 

 by age group, only 57% of individuals 12-17 years of age in the U.S. have completed their two dose COVID-19 vaccine series. One of the 

 of the ACIP for their updated guidance on extended intervals was to encourage vaccine hesitant parents concerned about myocarditis.

The CDC recommends COVID-19 vaccines to prevent complications such as myocarditis. One 

 demonstrated that COVID-19 patients have a 16 times higher risk of myocarditis than individuals without COVID-19. One recent 

 revealed that unvaccinated patients (12-30 years of age) with COVID-19 have a 17 times higher risk of developing myocarditis than COVID-19 vaccinated individuals.

Currently, there is no available data regarding extended COVID-19 vaccine intervals for children 5-11 years of age. Therefore, the recommended interval between the first and second dose of Pfizer-BioNTech for this population should remain at 3 weeks. 

The shorter 3-week interval for Pfizer-BioNTech and 4 weeks for Moderna between the first and second vaccine dose is still also recommended for the following groups: individuals who are moderately or severely immunocompromised; adults 65 years and older; and those who need protection quickly due to high community transmission or risk of developing severe COVID-19.

Articles

This guidance discusses that individuals 12 years and older can receive the second dose of the Pfizer-BioNTech vaccine 3-8 weeks after the first. Additionally, the interval for those 18 years and older for Moderna is 4-8 weeks.

Second mRNA COVID-19 Vaccine in Primary Series Can Be Extended to 8 Weeks for Some Individuals 

The CDC released the first real world data February 15 in a 

 (MMWR) that infants younger than 6 months were overall 61% less likely to be hospitalized from COVID-19 if their mothers were vaccinated during pregnancy through completion of a 2-dose primary mRNA COVID-19 vaccine series with either Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax). This news of COVID-19 protection is extremely critical since vaccination of infants less than 6 months is not currently being studied.

The case-control study analyzed data from 20 pediatric hospitals in 17 states July 1, 2021-January 17, 2022 and included 379 infants. Additionally, the Delta variant was predominant through mid-December after which Omicron became dominant. Mothers who were partially vaccinated were excluded from the study, which was defined using the following criteria:

Received 1 vaccine dose during pregnancy and none prior to pregnancy

Received 2 doses of COVID-19 vaccine before pregnancy

Received more than 2 doses of COVID-19 vaccine at least 14 days before delivery

Among 176 infants younger than 6 months hospitalized with COVID-19, 148 (84%) were born to mothers who were not vaccinated during pregnancy. Additionally, 88% of infants less than 6 months with COVID-19 who were admitted to the ICU were born to unvaccinated mothers. One infant who died during the study was also born to a mother who was not vaccinated while pregnant.

“I cannot emphasize enough how today’s findings reinforce the importance of COVID-19 vaccination during pregnancy, both to protect the people who are pregnant and to help protect their babies,” said Dana Meaney-Delman, MD, Chief of Infant Outcomes Monitoring Research and Prevention Branch in a 

Additionally, this adds to the growing body of 

 demonstrating the importance of vaccination for maternal protection against COVID-19 and to pass antibodies to infants who are unable to get vaccinated at this time. 

, individuals who are pregnant are at an increased risk of severe COVID-19 that could result in hospitalization and mortality. Therefore, COVID-19 vaccination is recommended during pregnancy by the CDC and the 

American College of Obstetricians and Gynecologists

Healthcare providers can play an important role in educating and administering mRNA COVID-19 vaccines to pregnant patients to improve maternal and infant health outcomes.

The CDC released the first real world data February 15 in a Morbidity and Mortality Weekly Report (MMWR) that infants younger than 6 months were overall 61% less likely to be hospitalized from COVID-19 if their mothers were vaccinated during pregnancy through completion of a 2-dose primary mRNA COVID-19 vaccine series with either Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax). 

CDC Study Shows mRNA Vaccination During Pregnancy Protects Infants From COVID-19

Advisory Committee on Immunization Practices

 (ACIP) met February 4, 2022, to provide further guidance for immunocompromised patients and address obstacles this population has encountered in getting an additional COVID-19 dose. The revised recommendations say thatpatients who are moderately or severely immunocompromised should receive a fourth dose of an mRNA vaccine at least three months after the last dose of a three-dose series.

 that immunocompromised patients who received the mRNA Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax) vaccines get a fourth shot at least five months after their third vaccination. However, these recommendations may have been lost in the shuffle. CNN reported that some pharmacies have turned away immunocompromised patients seeking a fourth shot. Pharmacies turning away patients could be the result of unclear messaging or confusion regarding the guidance. 

“There has been recent confusion about the recommendations for this population, including reports of people who choose mRNA COVID-19 vaccines being denied their fourth dose,” said Elisha Hall, Ph.D., CDC health education specialist, at the 

 according to CNN’s coverage. The presentation emphasized that individuals with immunocompromising health conditions (e.g., active cancer and organ transplant recipients) and patients who take immunosuppressive medications are at increased risk of severe COVID-19 and may not have a strong enough protective immune response after initial vaccination. Additionally, this population can experience waning vaccine protection over time. 

The updated recommendations are based on 

 demonstrating that patients who are immunocompromised have a stronger immune response when a fourth dose is administered one to three months after the third dose. The guidance further clarifies the recommendation language that immunocompromised patients should receive a three-dose primary series, with a fourth dose considered the booster. For people who are not in the immunocompromised category, the recommended sequences remains a two-dose primary series followed by a booster.

Pharmacies should ensure they are following CDC recommendations to ensure immunocompromised patients are current on their COVID-19 vaccine series.

These recommendations apply to immunocompromised patients, ages 12 years and older, who have received the Pfizer-BioNTech vaccine and those 18 year and older who have received the Moderna vaccine.

Under the revised guidance, ACIP is also recommending that immunocompromised patients who received one primary dose of the Johnson & Johnson vaccine also get an additional dose of an mRNA vaccine at least 28 days later followed by an mRNA booster vaccine — a third dose — at least two months after second shot.

Due to the risk of thrombosis with the Johnson & Johnson vaccine, the CDC recently 

 an mRNA as the preferred COVID-19 vaccine.

, the CDC has the authority to make these guideline revisions independently once a product has been approved. They may differ from the FDA prescribing information.

ACIP has also recommended that healthcare providers can, on a case-by-case basis, administer additional doses of the Pfizer-BioNTech or Moderna vaccines outside of the FDA and CDC dosing intervals “based on clinical judgement when the benefits of vaccination are deemed to outweigh the potential and unknown risks.”

Patients who are immunocompromised are advised to get a three-dose series and then a fourth dose. 

CDC’s Advisory Committee Is Recommending Shortened Interval for COVID-19 Boosters for Immunocompromised Patients

Moderna’s COVID-19 vaccine, sold under the brand name 

 for the prevention of COVID-19 in adults 18 years and older yesterday (Jan. 31).

It is the second COVID-19 to receive full approval. 

’s vaccine was the first. It was approved in August 2021.

“While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization (EUA), we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” said Janet Woodcock, M.D., acting FDA Commissioner in a 

“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” said Stéphane Bancel, Moderna’s CEO, said in a 

Moderna’s COVID-19 Vaccine has been available under EUA for individuals 18 years and older since December 2020. Approximately 204 million doses have been administered according to the latest 

Full approval was granted based on the FDA’s evaluation of safety and efficacy from the ongoing randomized, placebo-controlled 

, which included 14,287 patients in the vaccine group and 14,164 study participants in the placebo group. The study demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases occurring in the vaccine group and 744 cases in the placebo group. Additionally, the vaccine was 98% effective at preventing severe COVID-19 disease. The data used for the FDA analysis occurred prior to the omicron variant started to circulate.

The most common reported adverse effects were pain, redness, and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, fever, and swollen lymph nodes under the arm. The 

myocarditis and pericarditis following vaccination

, especially seven days after the second vaccine dose in males 18-24 years. Therefore, the FDA is requiring postmarketing surveillance studies to further assess the risk of myocarditis and pericarditis with Spikevax.

Spikevax is administered as a two-dose series intramuscularly 28 days apart, which is considered the primary series. Individuals 18 years and older are 

 for a booster dose five months after completing the primary series based on CDC guidelines.

, the effectiveness of a third dose of Moderna and Pfizer-BioNTech vaccines were evaluated in patients who were immunocompetent and in individuals with immunocompromising conditions. The study showed that a third dose — a booster dose — increased vaccine efficacy against hospitalization among adults without and with immunocompromising conditions from 82% to 97% and from 69% to 88% respectively. 

FDA is requiring postmarketing surveillance studies to further assess the risk of myocarditis and pericarditis from the vaccine, which is being sold under the brand name Spikevax.

Moderna’s COVID-19 Vaccine Receives Full FDA Approval

 has purchased one billion at-home COVID-19 rapid tests, and Americans can order them for free with a kick-off date beginning today.

The site is active now and appears to be working.

There will be 500 million tests available through the initial ordering process. Individuals can order their tests online at 

, and the Administration says they will start shipping them within 7-12 days of ordering. 

The website went live last week but the ordering function was not scheduled to start working till tomorrow. The administration apparently decided switch it on sooner than the announced start time.

Shipping is free, and there is no need to enter credit card information. The initial program permits the ordering of four free tests per household. The White House also says that a call line will also be launched so those without access to the internet will be able to place orders. 

The administration has also pledged to prioritize processing testing orders to communities experiencing the highest COVID-19 cases and mortality as part of a commitment to take into account health inequities and the disproportionate impact of COVID-19. The administration announcement about the testing program says it will work with “local organizations with deep experience serving communities of color, people living with disabilities, and other high-risk communities to serve as navigators, raise awareness about the program, and help people submit requests.”

Increasing the availability of at home tests comes at a critical time when COVID-19 transmission and hospitalizations are high, with the omicron variant accounting for approximately 

 of cases in the United States according to the latest CDC data. The administration also 

 that private health insurance companies are required to cover at-home COVID-19 tests for free starting Jan. 15, 2022. It has also made an additional 10 million tests available to schools nationwide. Private insurers are required to cover eight at-home tests per covered individual per month. However, that requirement leaves out uninsured Americans and those covered by Medicare. 

With the high demand of COVID-19 tests and limited availability through retailers, the launch of free tests through the Biden Administration’s efforts may help many families across the nation. However, a variety of issues may arise. 

Will the website crash  as millions, maybe even tens of millions, order tests? (So far, so good, today.) 

Will the wait times on the call lines be long? 

The tests will be shipped via the United States Postal Service. Will the postal service be capable of reliably delivering the tests? 

, there are approximately 332 million individuals residing in the U.S. Will there be enough tests? 

Will the people who need tests be able to get them? 

The answers to these and many more questions will become apparent over the next few days and weeks as the administration rolls out an unprecedented effort to have people test themselves and family members for a disease.

Free At-Home Rapid COVID-19 Tests Available To Order Today, A Day Earlier Than Scheduled

Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) received 

 for the FDA on Dec. 22, 2021 for the treatment of mild-to-moderate COVID-19 in adults and children 12 years and older weighing at least 40 kilograms (88 pounds) with positive results of direct SARS-CoV-2 testing who are at high risk of progression to severe disease.

Pfizer has begun distributing Paxlovid, but it is available in limited supply. According to HHS, 64,970 courses had been distributed as of Jan. 7, 2022.

Institute for Safe Medication Practices (ISMP)

 has issued important safety concerns regarding Paxlovid and recommendations for physicians and pharmacists when prescribing and dispensing the medication.

, the recommended dose of Paxlovid for patients with normal renal function or mild renal impairment (estimated glomerular filtration rate (eGFR) 

 60 to < 90 ml/min) is 300 milligrams of nirmatrelvir (two, 150 mg tablets) with 100 milligrams ritonavir (one 100 mg tablet). Additionally, all 3 tablets must be taken together orally twice daily for five days. 

Patients with moderate renal impairment (eGFR 

 30 to < 60 ml/min) are supposed to take smaller doses: 150 mg of nirmatrelvir (one tablet) with 100 mg ritonavir (one tablet) taken together twice daily for five days. And patients with severe renal impairment (eGFR < 30 ml/min) are supposed to avoid Paxlovid altogether.

 to remove one of the nirmatrelvir tablets for both the morning and evening doses from each blister card and cover the empty blisters with pre-printed moderate renal impairment dosing instructions on all five cards with manufacturer-supplied stickers prior to dispensing Paxlovid. Pharmacists are also supposed to educate patients with moderate renal impairment that the packaging was altered to reflect the dosing changes. 

 to obtain additional stickers. Pharmacies should ensure that their staff are educated about these essential steps. Additionally, prescribers should ensure that the appropriate dosing is on all Paxlovid prescriptions for patients with moderate renal impairment. 

There are also drug interactions to be aware of with Paxlovid because it is an inhibitor of CYP3A, and it is critical for pharmacists to educate prescribers and patients about these since they can result in decreased Paxlovid efficacy or toxicity of the patient’s other therapies. Paxlovid treatment is contraindicated with the following medications:

Alpha1-adrenoreceptor antagonist: alfuzosin

Antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine

Antipsychotics: lurasidone, pimozide, clozapine

Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine

PDE5 inhibitor: sildenafil (Revatio) for pulmonary arterial hypertension

Sedative/hypnotics: triazolam, oral midazolam

Anticonvulsants: carbamazepine, phenobarbital, phenytoin

Smaller doses are recommended for people with moderate renal impairment and the treatment should not be taken by people with serious kidney disease. There are also drug interactions to be aware of because Paxlovid is an inhibitor of CYP3A.