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▎The content team editor of WuXi AppTec.
In order to alleviate the challenges of insufficient supply of the new crown vaccine, the strategy of “mixed vaccination” of different vaccines has attracted international attention.
However, there has been a lack of data on the immunogenicity, reactogenicity, or safety of such vaccination programs.
Today, "The Lancet" recently published important data from a large randomized trial in the United Kingdom, by evaluating the combination of AstraZeneca's new crown vaccine ChAdOx1 nCoV-19 and Pfizer/BioNTech's new crown vaccine BNT162b2, and analyzing the local subjects after vaccination And systemic reactions, as well as laboratory blood and biochemical test results, provide preliminary data for the safety of mixed vaccination.
Screenshot source: The Lancet Com-COV study, led by the Oxford University team, is a multi-center, single-blind, randomized, heterologous prime-boost (heterologous prime-boost) new crown vaccination study in the United Kingdom.
Provide evidence to guide different vaccine combinations to provide more flexible vaccination procedures and promote early vaccination of more people.
The study used a two-dose vaccination protocol (first injection [prime], second injection [-boost]), and compared the two vaccines BNT162b2 (hereinafter referred to as BNT) and ChAdOx1 nCoV-19 (hereinafter referred to as ChAd).
There are 4 combinations of needle vaccination, and the impact of different vaccination intervals (28 days or 84 days).
The four vaccination combinations include: two injections of ChAd, two injections of BNT, ChAd followed by BNT, and BNT followed by ChAd; the four inoculation combinations have tested two inoculation intervals.
A total of 830 subjects were enrolled in the study, all of whom were 50 years of age and older, and had no comorbid diseases, or the comorbid diseases were only mild to moderate and well-controlled.
This analysis provides preliminary reactogenicity and safety data: reactogenicity data comes from self-reported local and systemic symptoms of subjects in the 28-day interval group, collected within 7 days after the first and second shots ; Hematology and biochemical safety monitoring data come from 100 subjects in the 28-day interval group, collected at the baseline (before the first needle), 28th day (before the second needle) and 7 days after the second needle.
A total of 463 subjects received 28 days between the two doses.
All subjects received the first dose of vaccine, and 461 received the second dose of booster vaccine.
The median age of all 463 subjects was 57 years (range 50-69 years), women accounted for 46%, ethnic minorities accounted for 25%, and the baseline characteristics of the four groups of subjects with different "mixed" regimens were balanced.
Image source: Com-COV research official website.
The results show that among the people who used the same vaccine with two injections, the ChAd group and the BNT group after the first injection and the BNT group recorded higher systemic reactogenicity.
Compared with two doses of the same vaccine, the two mixed vaccination regimens caused more obvious systemic reactions after the second dose.
Take the report of self-feeling (feverish) as an example: 34% (37 cases/110 cases) of ChAd/BNT combination vaccinators; 10% (11 cases/112 cases) of ChAd vaccinators with two injections The absolute difference in the proportion of vaccinators with this response was 24% (95% CI 13%-35%).
Among the vaccinators of the BNT/ChAd combination, 41% (47 cases/114 cases); among the two injections of BNT vaccinators, 21% (24 cases/112 cases), the absolute difference in the proportion of vaccinators with this reaction was 21% (95% CI 8%-33%).
Similar trends were observed in chills, fatigue, headaches, joint pain, discomfort, and muscle aches.
No vaccinated person was hospitalized because of these symptoms.
Most of these vaccination reactions occurred within 48 hours of vaccination.
▲ Within 7 days of the first injection (prime, the first three lines) and within 7 days of the second injection (boost, the last three lines), the subject's self-reported local and systemic reactions, and severity.
(Image source: Reference [1]; click on the image to enlarge it.
) The local reactions in the picture include: hardening, itching, pain, redness, swelling, and warmth at the inoculation site.
Systemic reactions include: chills, fatigue, fever (fever, ≥38.
0°C), fever (feverish, no temperature record), headache, joint pain, malaise, muscle aches, nausea, vomiting, and diarrhea.
The severity was mild, moderate, severe, and hospitalized.
Before the start of the study, the subjects had been told that acetaminophen might reduce the side effects of the vaccine, but the researchers did not actively recommend them to take preventive medication.
The actual statistical results show that a certain proportion of vaccinators in each group took acetaminophen 48 hours after the second vaccination, and the proportion of subjects with mixed vaccination took a higher proportion.
Two injections of ChAd: 36% (40 cases/112 cases), ChAd/BNT combination: 57% (63 cases/110 cases), two injections of BNT: 41% (48 cases/117 cases) ), vaccination of BNT/ChAd combination: the proportion of medication is 60% (68 cases/114 cases).
The paper pointed out, "It is particularly noteworthy that these data were obtained in subjects over 50 years old, and in younger people, the reactogenicity may be higher.
" Two doses of the same vaccine and a mixed vaccination of two vaccines Between the protocols, the hematological and biochemical characteristics of the vaccinators were similar.
All laboratory adverse events in the mixed vaccination regimen were grade 2 or lower; on the 7th day after the second booster vaccination, there was no thrombocytopenia in any group.
Picture source: The 123RF paper concluded that, "Before obtaining more complete safety data and immunogenicity results, these data indicate that the mixed vaccination regimen used in the Com-COV study may have some short-term effects, which is helpful for acetaminophen.
To alleviate these symptoms.
But you can rest assured that all reactogenic symptoms are short-lived, and the limited hematology and biochemical test data do not cause concern.
"The corresponding author of the study, Dr.
Matthew Snape, professor of vaccinology at the University of Oxford, added, "The important thing is that (the mixed vaccination regimen used in the study) has no safety issues or signals, but this does not tell us whether the immune response will be affected.
We hope to report these data in the next few months.
"At present, the Com-COV study is continuing to evaluate the long-term effects of the mixed vaccination regimen of BNT162b2 and ChAdOx1 nCoV-19.
Among them, the main immunological results data is expected to be announced in June 2021, and the study will also add analysis to acetamido Whether phenol preventive medication or conventional medication will reduce these reactions.
In addition, the research team will also evaluate other available new crown vaccine combinations.
It is
expected that longer-term data can further provide reference for mixed vaccination.
Authoritative research on new crown research: What are the consequences of only one shot of the new crown vaccine? JAMA has published two articles: Vaccination reduces the risk of asymptomatic infection by 72%-86%.
"The Lancet" National data in Israel: Reduce 95% of infections.
New crown vaccination promotes a substantial decline in the protection effectiveness of 78%.
Sinopharm's new crown is inactivated Vaccine Phase 3 clinical results released.
The detailed data of the Phase 3 trial of Kexing inactivated vaccines are released.
Reference materials for 100% prevention of moderate to severe COVID-19 [1] Robert H Shaw, et al.
, (2021).
Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)01115-6[2] Com-Cov.
Retrieved May 13, 2021, from https://comcovstudy.
org.
uk/home[3] Preliminary data suggests mixing COVID-19 vaccine increases reactogenicity.
Retrieved May 13, 2021, from New Coronavirus Vaccination Technical Guide (First Edition).
Retrieved May 13, 2021, from Note: This article aims to introduce the progress of medical and health research , Is not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
In order to alleviate the challenges of insufficient supply of the new crown vaccine, the strategy of “mixed vaccination” of different vaccines has attracted international attention.
However, there has been a lack of data on the immunogenicity, reactogenicity, or safety of such vaccination programs.
Today, "The Lancet" recently published important data from a large randomized trial in the United Kingdom, by evaluating the combination of AstraZeneca's new crown vaccine ChAdOx1 nCoV-19 and Pfizer/BioNTech's new crown vaccine BNT162b2, and analyzing the local subjects after vaccination And systemic reactions, as well as laboratory blood and biochemical test results, provide preliminary data for the safety of mixed vaccination.
Screenshot source: The Lancet Com-COV study, led by the Oxford University team, is a multi-center, single-blind, randomized, heterologous prime-boost (heterologous prime-boost) new crown vaccination study in the United Kingdom.
Provide evidence to guide different vaccine combinations to provide more flexible vaccination procedures and promote early vaccination of more people.
The study used a two-dose vaccination protocol (first injection [prime], second injection [-boost]), and compared the two vaccines BNT162b2 (hereinafter referred to as BNT) and ChAdOx1 nCoV-19 (hereinafter referred to as ChAd).
There are 4 combinations of needle vaccination, and the impact of different vaccination intervals (28 days or 84 days).
The four vaccination combinations include: two injections of ChAd, two injections of BNT, ChAd followed by BNT, and BNT followed by ChAd; the four inoculation combinations have tested two inoculation intervals.
A total of 830 subjects were enrolled in the study, all of whom were 50 years of age and older, and had no comorbid diseases, or the comorbid diseases were only mild to moderate and well-controlled.
This analysis provides preliminary reactogenicity and safety data: reactogenicity data comes from self-reported local and systemic symptoms of subjects in the 28-day interval group, collected within 7 days after the first and second shots ; Hematology and biochemical safety monitoring data come from 100 subjects in the 28-day interval group, collected at the baseline (before the first needle), 28th day (before the second needle) and 7 days after the second needle.
A total of 463 subjects received 28 days between the two doses.
All subjects received the first dose of vaccine, and 461 received the second dose of booster vaccine.
The median age of all 463 subjects was 57 years (range 50-69 years), women accounted for 46%, ethnic minorities accounted for 25%, and the baseline characteristics of the four groups of subjects with different "mixed" regimens were balanced.
Image source: Com-COV research official website.
The results show that among the people who used the same vaccine with two injections, the ChAd group and the BNT group after the first injection and the BNT group recorded higher systemic reactogenicity.
Compared with two doses of the same vaccine, the two mixed vaccination regimens caused more obvious systemic reactions after the second dose.
Take the report of self-feeling (feverish) as an example: 34% (37 cases/110 cases) of ChAd/BNT combination vaccinators; 10% (11 cases/112 cases) of ChAd vaccinators with two injections The absolute difference in the proportion of vaccinators with this response was 24% (95% CI 13%-35%).
Among the vaccinators of the BNT/ChAd combination, 41% (47 cases/114 cases); among the two injections of BNT vaccinators, 21% (24 cases/112 cases), the absolute difference in the proportion of vaccinators with this reaction was 21% (95% CI 8%-33%).
Similar trends were observed in chills, fatigue, headaches, joint pain, discomfort, and muscle aches.
No vaccinated person was hospitalized because of these symptoms.
Most of these vaccination reactions occurred within 48 hours of vaccination.
▲ Within 7 days of the first injection (prime, the first three lines) and within 7 days of the second injection (boost, the last three lines), the subject's self-reported local and systemic reactions, and severity.
(Image source: Reference [1]; click on the image to enlarge it.
) The local reactions in the picture include: hardening, itching, pain, redness, swelling, and warmth at the inoculation site.
Systemic reactions include: chills, fatigue, fever (fever, ≥38.
0°C), fever (feverish, no temperature record), headache, joint pain, malaise, muscle aches, nausea, vomiting, and diarrhea.
The severity was mild, moderate, severe, and hospitalized.
Before the start of the study, the subjects had been told that acetaminophen might reduce the side effects of the vaccine, but the researchers did not actively recommend them to take preventive medication.
The actual statistical results show that a certain proportion of vaccinators in each group took acetaminophen 48 hours after the second vaccination, and the proportion of subjects with mixed vaccination took a higher proportion.
Two injections of ChAd: 36% (40 cases/112 cases), ChAd/BNT combination: 57% (63 cases/110 cases), two injections of BNT: 41% (48 cases/117 cases) ), vaccination of BNT/ChAd combination: the proportion of medication is 60% (68 cases/114 cases).
The paper pointed out, "It is particularly noteworthy that these data were obtained in subjects over 50 years old, and in younger people, the reactogenicity may be higher.
" Two doses of the same vaccine and a mixed vaccination of two vaccines Between the protocols, the hematological and biochemical characteristics of the vaccinators were similar.
All laboratory adverse events in the mixed vaccination regimen were grade 2 or lower; on the 7th day after the second booster vaccination, there was no thrombocytopenia in any group.
Picture source: The 123RF paper concluded that, "Before obtaining more complete safety data and immunogenicity results, these data indicate that the mixed vaccination regimen used in the Com-COV study may have some short-term effects, which is helpful for acetaminophen.
To alleviate these symptoms.
But you can rest assured that all reactogenic symptoms are short-lived, and the limited hematology and biochemical test data do not cause concern.
"The corresponding author of the study, Dr.
Matthew Snape, professor of vaccinology at the University of Oxford, added, "The important thing is that (the mixed vaccination regimen used in the study) has no safety issues or signals, but this does not tell us whether the immune response will be affected.
We hope to report these data in the next few months.
"At present, the Com-COV study is continuing to evaluate the long-term effects of the mixed vaccination regimen of BNT162b2 and ChAdOx1 nCoV-19.
Among them, the main immunological results data is expected to be announced in June 2021, and the study will also add analysis to acetamido Whether phenol preventive medication or conventional medication will reduce these reactions.
In addition, the research team will also evaluate other available new crown vaccine combinations.
It is
expected that longer-term data can further provide reference for mixed vaccination.
Authoritative research on new crown research: What are the consequences of only one shot of the new crown vaccine? JAMA has published two articles: Vaccination reduces the risk of asymptomatic infection by 72%-86%.
"The Lancet" National data in Israel: Reduce 95% of infections.
New crown vaccination promotes a substantial decline in the protection effectiveness of 78%.
Sinopharm's new crown is inactivated Vaccine Phase 3 clinical results released.
The detailed data of the Phase 3 trial of Kexing inactivated vaccines are released.
Reference materials for 100% prevention of moderate to severe COVID-19 [1] Robert H Shaw, et al.
, (2021).
Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)01115-6[2] Com-Cov.
Retrieved May 13, 2021, from https://comcovstudy.
org.
uk/home[3] Preliminary data suggests mixing COVID-19 vaccine increases reactogenicity.
Retrieved May 13, 2021, from New Coronavirus Vaccination Technical Guide (First Edition).
Retrieved May 13, 2021, from Note: This article aims to introduce the progress of medical and health research , Is not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
