Nina Cosdon

Today, the US Food and Drug Administration (FDA) approved booster doses of the Pfizer-BioNTech 

Now, children as young as 5 can receive a third dose of the vaccine at 5 or more months after their initial 2-dose Pfizer-BioNTech vaccination series.

“While it has largely been the case that 

 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized,” Robert M. Califf, MD, the FDA Commissioner, said in a statement explaining the expanded recommendation. “Children may also experience longer term effects, even following initially mild disease.”

There has been a growing push for approval of boosters in children. “Emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.”

 Pfizer-BioNTech booster shots for children 12 years and older. Simultaneous with this expansion to adolescents, the FDA shortened the time in between second and third doses from 6 months to 5 months.

Pfizer-BioNTech is currently the only COVID-19 vaccine approved for children and adolescents (5-17 years of age). Moderna 

 filing for EUA of its mRNA COVID-19 vaccine for children as young as 6 months, but Pfizer-BioNTech is still the only COVID-19 vaccine FDA- and 

 for primary vaccination and booster vaccination in children.

The efficacy of COVID-19 booster vaccination in pediatric populations was based on results from an ongoing, randomized, placebo-controlled study. 

 contributed to the initial FDA decision to approve Pfizer-BioNTech COVID-19 vaccine for children 5-11 years.

Investigators monitored the safety and antibody responses of 67 children who received a booster dose 7-9 months after their initial 2-dose Pfizer-BioNTech vaccine series. Comparatively, COVID-19 antibody titers increased significantly after a booster dose.

Another study of approximately 400 children in this age group assessed the safety of receiving a booster 5-9 months after primary vaccination. The most common adverse events were pain, injection site reactions (redness and swelling), fatigue, headache, muscle or joint pain, chills, and fever.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” Califf said. “If your child is eligible for the Pfizer-BioNTech COVID-19 vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”

Articles

Children 5 to 11 years old now can receive a booster shot of the Pfizer-BioNTech vaccine.  

Pfizer-BioNTech Booster Dose Approved for Children 5 and Older

This article was originally published on ContagionLive.com.

The US Food and Drug Administration (FDA) 

 Friday that an advisory committee meeting to discuss Pfizer and BioNTech's emergency use authorization request for its COVID-19 vaccine for children 6 months through 4 years of age would be postponed after the companies cited new data.

Pfizer-BioNTech had pushed for FDA approval despite some 

 suggesting 2 doses of its vaccine did not evoke the desired autoimmune response. Only children 6 months-2 years old demonstrated an adequate immune response after 2 doses of Pfizer-BioNTech’s COVID-19 vaccine; vaccine trial doses for young children were 3 mg, or 1/10 the strength of the adult doses.

Pfizer-BioNTech deferring the Emergency Use Authorization (EUA) request to wait for more conclusive evidence of adequate autoimmune response comes as a bit of a shock. On Tuesday, Pfizer CEO Albert Bourla stated that the chance was “very high” the FDA would authorize their vaccine in children under 5.

"I think that they will be pleased with the data and they will approve," Bourla told 

Now, Pfizer-BioNTech is saying they will wait for data on a 3-dose vaccine regimen before requesting to administer vaccines in children 6 months-4 years old.

 from the FDA and European Medicines Agency to add a third dose to its clinical vaccine trial of children 6 months to 4 years old. At the time they announced the dosage change, Pfizer-BioNTech said, “These updates were informed by the effectiveness data for three doses of the vaccine for people 16 years and older, and the early laboratory data observed with Delta and other variants of concern, including Omicron, which suggest that people vaccinated with three doses of a COVID- 19 vaccine may have a higher degree of protection.”

Pfizer-BioNTech backtracked in hopes that data from the 3-dose trial will show a higher autoimmune response in young children. They anticipate results from the third dose trial to be available in early April.

Vaccines and Related Biological Products Advisory Committee (VRBPAC)

 will meet on February 15 to discuss Pfizer-BioNTech’s request for Emergency Use Authorization (EUA) to deploy its vaccine among children 6 months-4 years of age.

The FDA noted the concerning rise in hospitalizations of young children with severe COVID-19 disease, as the highly infectious Omicron variant continues to spread.

"Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. Furthermore, children are not small adults. Because they're still growing and developing, it's critical that these vaccines are evaluated in well-designed and well-conducted clinical trials," acting FDA commissioner Janet Woodcock, MD, said in a statement.

only COVID-19 vaccine approved for children and adolescents

 under 18 years, Pfizer-BioNTech’s vaccine has been shown to wane in efficacy after a few months. For this reason, and due to Omicron’s unprecedented ability to cause breakthrough infections, the FDA and US Centers for Disease Control and Prevention (CDC) updated their booster vaccine recommendations.

 are strongly recommended to receive an additional mRNA booster vaccine:

6 months after initial vaccination for Moderna (mRNA-1273) recipients

5 months after initial vaccination for Pfizer-BioNTech (BNT162b)

2 months after initial vaccination for Janssen (Johnson & Johnson; Ad26.COV2.S) recipients

mRNA vaccines are currently preferred over the Janssen vaccine

, as boosters and as a primary series, though vaccination with Janssen is recommended if no other COVID-19 vaccine is available.

The postponement will allow for additional time to review new data regarding the emergency use authorization request. 



Pfizer-BioNTech Delay FDA Request for COVID-19 Vaccine for Kids Under 5

Older adults face a greater risk of contracting new medical issues after COVID-19 infection than individuals in younger age groups. That’s the main finding of a study published in 

 that sought to characterize the risk of persistent clinical conditions, or sequelae, among adults 65 years and older.

The observational study used the UnitedHealth Group’s clinical research database to access administrative claims and outpatient laboratory test results from 133366 adults who were diagnosed with COVID-19 before April 1, 2020. Included adults were ≥65 in 2020 and enrolled in a Medicare Advantage plan that covered prescription drugs.

The investigators recorded any persistent or new conditions that began at least 21 days after COVID-19 diagnosis. Over several months, they calculated the increased risk of COVID-19-triggered sequalae by age, race, sex, and whether patients were admitted to the hospital for their COVID-19 infection.

The cohort was matched to 3 comparison groups that did not contract COVID-19, including a 2020 comparison group, an historical 2019 comparison group, and an historical comparison group with preexisting viral lower 

The investigators found that 32% of individuals diagnosed with COVID-19 sought medical attention in the post-acute period for 1 or more new persistent conditions, 11% higher than the 2020 comparison group.

The most commonly reported sequalae included complications to the heart, kidneys, lungs, and liver. Compared with the 2020 group, COVID-19 patients were at increased risk of temporary respiratory failure, fatigue, high blood pressure, and mental health diagnoses. In comparison to the viral lower respiratory tract illness group, however, only respiratory failure, dementia, and fatigue were increased among people who contracted COVID-19.

The individuals admitted to the hospital with COVID-19 had a statistically significant elevated risk of most sequalae. The risk of several conditions was increased for men, Black people, and people over 75 years of age.

The results confirm an excess risk of new and persistent sequalae in adults 65 and older after COVID-19 infection.

More research is needed to establish cause of the sequalae, as not all diagnoses may be new conditions triggered by COVID-19 infection. The investigators concluded, “Understanding the magnitude of risk for the most important clinical sequelae might enhance their diagnosis and the management of individuals with sequelae after acute SARS-CoV-2 infection.”

Investigators found that 32% of older adults diagnosed with COVID-19 sought medical attention in the post-acute period.

Many Older Adults Face New Clinical Conditions After COVID-19 Infection

Monoclonal antibody treatments no longer an option when it comes to treating the Omicron variant of COVID-19, the US Food and Drug Administration (FDA) ruled this week. In revising its previous approval of the therapies, the FDA 

 that they’re unlikely to be effective against Omicron and wants to spare patients the risk of side effects such as injection site soreness or allergic reactions.

The agency stated that it “revised the authorizations for two monoclonal antibody treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.”

The decision comes in light of Centers for Disease Control and Prevention (CDC) data that suggests the Omicron variant is responsible for over 99% of COVID-19 cases in the US. Because it is highly unlikely a patient will be infected with any variant other than Omicron, the FDA said that no monoclonal antibody treatment is to be administered at this time.

The FDA added however that “there are 

—Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir—that are expected to work against the Omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should consult the NIH [National Institutes of Health] panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.”

Monoclonal antibodies are made in a laboratory to mimic the antibodies produced by the body’s immune system. Monoclonal antibodies, introduced to the body through intravenous (IV) injection, look for and attach to the SARS-CoV-2 spike protein, blocking the virus’s ability to enter cells and slowing down the infection.

Monoclonal antibody treatment has been shown to reduce the risk of COVID-19 hospitalization, as well as decrease the amount of virus in a person’s blood.

The decision to rescind approval of monoclonal antibody treatment for the Omicron variant has been met with some resistance, most notably from Florida Governor Ron DeSantis.

DeSantis called upon the Biden Administration to reverse the decision, saying, “Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law…. This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives.”

DeSantis argued that even if less effective against Omicron, monoclonal antibody treatment is “better than nothing.”

In a statement from Patrizia Cavazzoni, MD, the director of the Center for Drug Evaluation and Research, the FDA emphasized, “While it’s critical that we have ways to treat those who contract COVID-19, the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death.”

In making the ruling, the FDA stated that it wants to spare patients the risk of side effects such as injection site soreness or allergic reactions for treatments unlikely to work.

Monoclonal Antibody Treatments Called Ineffective Against Omicron

Most experts believe that we will never get rid of COVID-19. On the bright side, that’s because they believe that it will become endemic, evolving into the sort of illness for which an individual might need a yearly vaccine, similar to treatment for influenza. On the not-so-bright side, many people suffer from 

, and since the disease only attacked in early 2020, experts aren’t sure of exactly what “long means.” Weeks? Months? Years?

A recent study illustrates that long COVID’s physical, mental, and cognitive symptoms can cling to some patients for at least a year. The patients in the study had to go to intensive care units (ICUs) because of the severity of infection.

The exploratory prospective multicenter cohort study was conducted in the ICUs of 11 Dutch hospitals and published yesterday in the 

Journal of the American Medical Association

). Investigators included 452 patients aged 16 and older who survived ICU admission during the first COVID-19 surge (March 1-July 1, 2020). The patients were followed up for 1 year following their release from the ICU, and the final follow-up date was June 16, 2021.

The main outcomes were physical symptoms (including frailty, fatigue, and other physical problems), mental symptoms (anxiety, depression, PTSD), and cognitive symptoms self-reported 1 year after ICU treatment.

Of the initial patient cohort, 301 (66.8%) were included in the study. The average age was 61.2 years, the average duration of ICU stay was 18 days, and 71.5% were male. A year after their release from the ICU, 74.3% of patients reported physical symptoms, 26.2% reported mental symptoms, and 16.2% reported cognitive symptoms.

The most commonly reported new physical problems were weakened condition (38.9%), joint stiffness (26.3%), joint pain (25.5%), muscle weakness (24.8%), and myalgia (21.3%).

The respondents indicated that their continued COVID-19 symptoms make it difficult to go about their day-to-day lives, with 58% of ICU survivors saying they had problems returning to work.

This frequency of symptoms 1 year after recovering from severe COVID-19 disease is concerning, as much is still unknown about “long covid” and the long-term health impact of COVID-19 infection.

This frequency of symptoms 1 year after recovering from severe COVID-19 disease is concerning, as much is still unknown about “long COVID.”

Long COVID Symptoms Last for a Year for Some Patients

A fourth dose of an mRNA seems not to be as effective against the Omicron variant of COVID-19 as it is against earlier variants, according to an Israeli study. The study was conducted by investigators with Sheba Medical Center in Israel. Gili Regev-Yochay, a lead researcher in the experiment, said that “we see an increase in antibodies, higher than after the third dose. However, we see many infected with Omicron who received the fourth dose. Granted, a bit less than in the control group, but still a lot of infections,” 

.1 Regev-Yochay added: “The bottom line is that the vaccine is excellent against the Alpha and Delta, for Omicron it’s not good enough.”

She also noted that the study found no significant difference in breakthrough infections between Pfizer/BioNTech and Moderna recipients.

Regev-Yochay said that the findings are preliminary and as of this writing, the study has not yet been released. The 

 reported that “hours after releasing the results, Sheba published a statement calling for ‘continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.’”

Over 500,000 Israelis have received 4 doses of mRNA COVID-19 vaccine. Currently, Israel’s Health Ministry has authorized a fourth shot to medical workers, the immunocompromised, and people 60 years and older. The Health Ministry estimates that over 6.3 million Israelis (2/3 of the population) have received at least 1 COVID-19 vaccine, and nearly 4.4 million have received 3 doses.

Israel’s cases remain high, which Prime Minister Naftali Bennett partially attributed to the country’s testing efforts; over 5% of the Israeli population is tested for COVID-19 each day.

Despite the preliminary evidence that a fourth dose will not offer sufficient protection against Omicron, Israel will continue to offer it to vulnerable populations, predicting that the variant’s contagions will wane in the coming weeks.

Additionally, “protection from serious morbidity, especially for the elderly population and at-risk population, is still afforded by this vaccine, and therefore I call on people to keep coming to get vaccinated,” Health Ministry director-general Nachman Ash said in a statement.

Despite the preliminary evidence that a fourth dose will not offer sufficient protection against Omicron, Israel will continue to offer it to vulnerable populations, predicting that the variant’s contagions will wane.