The CDC conducted a retrospective review of data from 40,627 pregnant women and found that COVID-19 vaccination during pregnancy did not increase the risk of preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women.
A CDC retrospective analysis of 1,228,664 patients who completed the two-dose primary vaccination from December 2020–October 2021, found the incidence of developing severe COVID-19 was 0.015%. All patients who developed severe COVID-19 had at least one risk factor for developing a severe infection.
A week after restating the six-month interval for a booster with the Moderna COVID-19 vaccine, the FDA shortened time period to five-months to match the recommendation for the Pfizer-BioNTech vaccine.
In a French case series of 92 kidney-transplant patients, a fourth dose of an mRNA vaccine produced a satisfactory antibody response in about half of the patients who had not responded to three doses. Antibody levels were measured a median of 29-days after the dose. In October the CDC recommended an additional booster dose, given six-months after the first booster dose, in moderately and severely immunocompromised patients.
NIH recommends AstraZeneca’s monoclonal antibody combination of tixagevimab and cilgavimab for COVID-19 prophylaxis in patients who are moderately to severely immunocompromised with an inadequate immune response to COVID-19 vaccination or not fully vaccinated due to a documented history of severe adverse reactions to a COVID-19 vaccine
NIH recommend that nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression, be treated with (in order of preference):
The FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a single booster dose for patients 12 through 15 years of age. Boosters for all patients 12 years and older can now be given as soon as five months after completion of primary series. Patients who are 5 through 11 years, who have undergone solid organ transplantation or are immunocompromised to an equivalent level are also now eligible for a booster dose. The interval between the primary series and a booster dose remains unchanged at six months for the Moderna COVID-19 vaccine and two months for the J&J vaccine.
South African researchers examined the results of 133,437 COVID-19 PCR tests and found the effectiveness of the Pfizer-BioNTech COVID-19 vaccine to be 70% after two doses in preventing hospitalizations for COVID-19 during a period when Omicron variant was the dominant strain compared to 93% when the Delta variant was the dominant strain.
In a second study, South African researchers compared the COVID-19 neutralization ability for the Beta, Delta, and Omicron variants with serum from 20 patents that had received two vaccinations with the Pfizer-BioNTech COVID-19 vaccine to a group of 20 patients that had received three injections. The researchers found that a third dose of the vaccine increased neutralization efficiency by a factor of 100 against the Omicron variant, but neutralization was lower by a factor of four against the omicron variant compared to the delta variant.
Rockefeller University researchers tested plasma from a variety of patients and found that recovered COVID-19 patients and patients that had received a third (booster) vaccination had enhanced protection against the Omicron variant.
CDC researchers reviewed data from VAERS and V-Safe voluntarily surveillance systems for children ages 5 to 11 years from 11/3/2021 to 12/19/2021. The researchers found the most common adverse reactions were injection site pain, fatigue and headache. ADR were mostly mild, and few cases of myocarditis were reported. It was estimated that 8.7 million doses were given during this time period to children 5 to 11 years.
A retrospective analysis of maternal and umbilical cord blood samples from 1,359 vaccinated pregnant women found that COVID-19 immunization before and throughout pregnancy resulted in detectable antibodies at delivery. The highest maternal and umbilical cord antibody levels were found in mothers who had received a complete vaccination course, had a prior history of COVID-19, or received a third-trimester booster dose.
The FDA issued an emergency use authorization (EUA) for convalescent plasma, on 8/23/2020, for the treatment of hospitalized patients with COVID-19. The original EUA was granted for any convalescent plasma product collected at FDA registered blood establishments. In February 2021, the FDA narrowed the EUA to high-antibody-titer convalescent plasma. The FDA no longer authorizes the use of plasma with low SARS-CoV-2 antibody titers. In December 2021, the FDA narrowed the EUA to treatment of COVID-19 in inpatients or outpatients who have an immunosuppressive disease or who are receiving immunosuppressive treatment. Fact sheets have been created for health care providers and patients. The Fact Sheet for HCPs has been revised to reflect the changes in the EUA. The documents include dosing instructions and potential adverse effects, such as allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
Kiniksa Pharmaceuticals announced that in a 29-day, 582 patient, Phase II/III trial (NCT0444746), treatment with mavrilimumab did not decrease the percentage of patients that required mechanical ventilation or died compared to placebo in patients with severe COVID-19 pneumonia and systemic hyperinflammation.
The FDA granted an emergency use authorization (EUA) for the combination of nirmatrelvir and ritonavir (Paxlovid, Pfizer), on 12/22/21, for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older weighing at least 88 pounds who are at high risk for progression to severe COVID-19. The treatment is dosed as two tablets of nirmatrelvir and one tablet of ritonavir taken together orally twice daily for five days. Please see the Fact Sheet for Healthcare Providers and Fact Sheet for Patients and Caregivers for additional information. Pfizer will begin shipping nirmatrelvir and ritonavir to the U.S. government immediately and expects to complete delivery of 10 million courses of treatment in 2022.
The FDA granted an emergency use authorization (EUA) for molnupiravir (Lagevrio, Merck), on 12/23/21, for the treatment of mild-to-moderate COVID-19 in patients 18 years of age and older who are at high risk for progression to severe COVID-19 and alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. The treatment is dosed as four tablets twice daily for five days. Molnupiravir is not recommended for use during pregnancy. Please see the Fact Sheet for Healthcare Providers and Fact Sheet for Patients and Caregivers for additional information. Merck will begin shipping 3.1 million doses of molnupiravir to the U.S. government as soon as a final label is approved by the FDA.
In the 29-day, 1,443 patient, Phase II/III, MOVe-OUT trial (NCT04575597), 6.8% of patients treated with a five-day course of molnupiravir were hospitalized or died compared to 9.7% with placebo in unvaccinated outpatients with mild-to-moderate COVID-19 with at least one risk factor to progress to severe disease. An interim analysis from 775 patients had suggested that 7.3% of patients treated with molnupiravir were hospitalized or died compared to 14.1% with placebo.
In the 28-day, 562 patient, Phase III, PINETREE trial (NCT04501952), 0.7% of patients treated with a 3-day course of remdesivir were hospitalized or died compared to 5.3% with placebo in nonhospitalized patients with at least one risk factor to progress to severe disease.
The CDC’s ACIP recommended that COVID-19 vaccines from Pfizer and Moderna should be preferred over the J&J vaccine due to the risk for a rare but potentially fatal thrombosis with thrombocytopenia syndrome with the J&J vaccine.
Moderna announced that preliminary lab results found that antibody levels after a booster (third) dose of their COVID-19 vaccine increased antibody levels that are thought to be high enough to neutralize the Omicron variant. A pre-print draft described how antibody levels were not high enough after two doses of the vaccine to neutralize the Omicron variant.
In a review of 4, 155, 361 patients that received an mRNA vaccine the rate of myocarditis was estimated to be 1.4 per 100 ,000 patients with the Pfizer-BioNTech COVDI-19 vaccine and 4.2 per 100 ,000 patients with the Moderna vaccine.
Sanofi and GSK announced that in a 521 patient, Phase I/II trial (NCT04537208), using their COVID-19 vaccine as a booster dose for vaccines from Pfizer/BioNTech, Moderna, Johnson & Johnson, and AstraZeneca resulted in an increase in neutralizing antibodies of 9- to 43-fold.
In the 29,582 patient, Phase III, PREVENT-19 trial (NCT04611802), two immunizations of NVX-CoV2373 (Novavax)ngiven 21-days apart resulted in 90.4% efficacy for developing a COVID-19 infection and 100% efficacy in preventing severe COVID-19.
Pfizer and BioNTech announced that in 4,500 patient, Phase I/II/III trial (NCT04816643), two 3 mcg doses of their COVID-19 vaccine given to patients 6 to 24 months old demonstrated immunogenicity similar to that seen with the adult dose in patients 16 to 25 years old. An inadequate response was elicited in patients 2 to under 5 years old with the 3 mcg dose, so a third dose will be evaluated in patients 6 months to under 5 years.
In a pre-print draft of a 28-day, 1,181 patient, Phase II trial (NCT04373460), 2.9% of patients treated with high titer convalescent plasma were hospitalized for COVID-19 compared to 6.3% with placebo in outpatients with recent onset of COVID-19.
Pfizer announced that in the 28-day, 2,246 patient, Phase II/III, EPIC-HR trial (NCT04960202), where 0.7% of patients treated with the combination of nirmatrelvir and ritonavir were hospitalized with no deaths compared to 6.5% who were hospitalized or died with placebo in unvaccinated patients with mild-to-moderate COVID-19 at risk to progress to severe illness. After an interim analysis found an 89% reduction in COVID-19 related hospitalization or death, the FDA agreed with the Data Monitoring Committee, that the trial could be stopped in November 2021.
Pfizer and BioNTech announced that preliminary lab results found that antibody levels after a booster (third) dose of their COVID-19 vaccine neutralized the Omicron variant. There was a 25-fold reduction in neutralization in patients that received just two vaccine doses. This may not be enough to prevent infection but may protect against severe disease. South African scientists tested antibody neutralization with serum from 12 patient that had received the Pfizer-BioNTech COVID-19 vaccine. Half of the patients had recovered from COVID-19. There was a 41-fold decrease in neutralization, but previously infected patients have high neutralization. Therefore, patients that have received a booster (third) dose may maintain neutralization against Omicron.
The FDA and CDC authorized a booster dose given six-months after their second dose of the Pfizer-BioNTech COVID-19 vaccine for 16 and 17 year-olds, on 12/9/2021.
The FDA approved an Emergency Use Authorization (EUA) for the combination of tixagevimab and cilgavimab (Evusheld, AstraZeneca) on 12/8/2021, for pre-exposure prophylaxis (prevention) of COVID-19 in patients 12 and older and weighting at least 40 kg with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, currently have COVID-19 or if COVID-19 vaccination is not recommended. Tixagevimab and cilgavimab are administered as a one-time intramuscular dose. The FDA advised against using the drug in hospitalized patients, because a benefit has not been demonstrated. Healthcare providers should review the Fact Sheet for information on the authorized use of casirivimab and imdevimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers. The U.S. government has purchased 700,000 doses that will be distributed at no charge.
In a 14-day, 941 patient, Phase III, CONTAIN COVID-19 trial (NCT04364737), treatment with convalescent plasma did not increase the number of patients that achieved clinical improvement compared to placebo in hospitalized COVID-19 patients.
ISMP issued a warning regarding use of an incorrect dose of the Pfizer-BioNTech COVID-19 vaccine. The pediatric vaccine (10 mcg/0.2 ml) has been used in patients 12 and older and the adult dosage (30 mcg/0.3 ml) has been used in patients under 12. ISMP further warns against diluting the adult vaccine to make a pediatric vaccine. Due to the vaccine being a suspension and the small volume, it would not be possible to create an accurate dose. To avoid errors, ISMP recommends
Medicago and GSK announced that in a 24,000 patient, Phase II/III trial (NCT04636697), where use of their COVID-19 vaccine had an overall vaccine efficacy 71% and 75.3% against the Delta variant.
A retrospective study of patients 21 years or younger who experienced myocarditis within 30 days of COVID-19 vaccination found most cases had a mild clinical course with rapid resolution of symptoms.
The 2,878 patient, Phase II, British COV-BOOST trial found that any COVID-19 vaccine can be used as a booster, regardless of the initial vaccine given. Patients received the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines. After the Pfizer-BioNTech vaccine a good immunity boost was achieved with vaccines from Pfizer-BioNTech, Moderna, Johnson & Johnson, Novavax, AstraZeneca and CureVac. There was also a good boost in immunity after the AstraZeneca vaccine with the same set of vaccines, plus an investigational vaccine from Valneva
In the 1,072 patient, Phase III, Com-COV2 trial, patients received their first COVID-19 immunization with either the AstraZeneca or Pfizer-BioNTech vaccines. The second dose was given with the same vaccine, a vaccine from Moderna or Novovax. Both the Moderna and Novovax vaccines elicited higher antibody titers following the AZ vaccine than AZ’s own vaccine. Compared to a second dose of the Pfizer-BioNTech vaccine, Moderna elicited higher antibody titers, but Novovax did not.
In the 28-day, 479 patient, Phase III, LIVE-AIR trial (NCT04351152), 84% of patients treated with lenzilumab were alive and did not require invasive mechanical ventilation compared to 78% with placebo in hospitalized patients with COVID-19, not requiring ventilation. 94% of patients received a corticosteroid, 72% received remdesivir and 69% received both.
A new variant of concern, designated Omicron, has been identified. The variant has several mutations that have been associated with increased transmissibility and higher immune evasion in other variants. Omicron also has new mutations in the spike protein that vaccine antibodies target. Right now, the threat is theoretical. But the vaccine manufacturers are already working on a vaccine to combat omicron, if tests show that current vaccine antibodies do not provide protection.
A review of French National Health Data from 3.9 million patients 75 years or older who had received at least 1 dose of Pfizer-BioNTech COVID-19 vaccine and 3.2 million who had received 2 doses found no increase in the incidence of acute myocardial infarction, stroke, or pulmonary embolism within 14 days of vaccine administration.
Merck announced that in the 29-day, 1,443 patient, Phase II/III, MOVe-OUT trial (NCT04575597), 6.8% of patients treated with a five-day course of molnupiravir were hospitalized or died compared to 9.7% with placebo in outpatients with mild-to-moderate COVID-19 with at least one risk factor to progress to severe disease. An interim analysis from 775 patients had suggested that 7.3% of patients treated with molnupiravir were hospitalized or died compared to 14.1% with placebo. The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend an emergency use authorization for molnupiravir.
The FDA approved a booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines for all patients 18 and older on 11/18/2021. On 11/19/2021, the CDC recommended booster doses of both vaccines for the same group of patients. All patients have already been approved to receive a booster of the J&J vaccine.
Pfizer and BioNTech announced that follow-up data from their COVID-19 vaccine teen study (NCT04368728) demonstrated 100% efficacy from seven days after the second dose through four months.
A Norwegian case–control study examined first-trimester pregnancies in 13,956 women from registry data and found no evidence of an increased risk for early pregnancy loss after Covid-19 vaccination.
In the 28-day, 2,052 patient, Phase III, PREPARE-IT 2 trial (NCT04460651), treatment with icosapent ethyl did not reduce hospitalization or death compared to placebo (13.69% vs 11.16%) in nonhospitalized Argentinian COVID-19 patients.
AZ announced that after six months 4,991 patients enrolled in the PROVENT trial, no cases of severe COVID-19 or COVID-19-related death occurred in patients that received AZD7442 compared to five cases of severe COVID-19 and two COVID-related deaths with placebo.
In the 15-day, 511 patient, Phase III, C3PO trial (NCT04355767 treatment with convalescent plasma did not reduce emergency treatment, hospitalization or death in high-risk outpatients with COVID-19.
In the 29-day, 583 patient, Phase III, COMET-ICE trial (NCT04545060), 1% of patients treated with sotrovimab
were hospitalized or died compared to placebo in outpatients with COVID-19 who were at high risk of progression to severe disease.
In a final analysis of the 30,451 patient, Phase III COVE trial (NCT04470427), vaccine efficacy was 93.2% to prevent COVID-19 and 98.2% to prevent severe disease with the Moderna COVID-19 vaccine.
In a 2,268 patient, Phase II/III trial (NCT04816643), two 10 mcg doses of the Pfizer-BioNTech COVID-19 vaccine given 21 days apart, to children 5 to 11 years, produced antibody titers comparable to the levels seen with two 30 mcg adult doses in adolescents and young adults age 16 to 25 years. Vaccine effectiveness was 90.7% one month after the second injection.
Pfizer announced interim data from 1,219 patients enrolled in the 28-day, 3,000 patient, Phase III, EPIC-HR trial (NCT04960202), where 0.8% of patients treated with the combination of PF-07321332 and ritonavir were hospitalized or died compared to 7% with placebo in unvaccinated patients with mild-to-moderate COVID-19 at risk to progress to severe illness. Due to the 89% reduction in COVID-19-related hospitalization or death, the FDA agreed with Data Monitoring Committee, the trial could be stopped. Pfizer plans to submit the data as part of a rolling NDA.
The United Kingdom Medicines and Healthcare products Regulatory Agency approved molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at risk to develop severe illness.
In the seven-day, 203 patient, Phase II, CONTAIN trial (NCT04435795), treatment with inhaled and intranasal ciclesonide did not improve symptom resolution compared to placebo in low-risk, Canadian outpatients with COVID-19.
In a long term extension of the Phase III, PREVENTION trial, patients that received REGEN-COV had an 81.6% reduction in developing symptomatic COVID-19 compared to placebo after eight months.
Pfizer and BioNTech COVID-19 vaccine approved for use in children 5 to 11 years of age.
Researchers analyzed historical and current data from Olmsted County, Minnesota and found the incidence of cerebral venous sinus thrombosis (CVST) had increased in females who received the J&J COVID-19 vaccine. The highest incidence of CVST was in women 40-49, followed by women aged 30 to 39 years.
CDC analysts compared the outcomes of 20,101 fully vaccinated immunocompromised adults to 69,116 fully vaccinated immunocompetent adults and found vaccine effectiveness to prevent COVID-19 related hospitalizations to be 77% for immunocompromised adults compared to 90% for immunocompetent adults. This decrease in effectiveness was present regardless of the type of vaccine used, patient’s geographic location, prevalence of the Delta variant or underlying cause for the immunocompromised state.
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