那个很多疑似的标准很低，疫苗组人数比安慰组还多，更大的怀疑是疫苗本身的反应，而不是假阴性 ------------------------- As specified in the protocol, suspected cases of symptomatic COVID-19 that were not PCRconfirmed were not recorded as adverse events unless they met regulatory criteria for seriousness. Two serious cases of suspected but unconfirmed COVID-19 were reported, both in the vaccine group, and narratives were reviewed. In one case, a 36-year-old male with no medical comorbidities experienced fever, malaise, nausea, headache and myalgias beginning on the day of Dose 2 and was hospitalized 3 days later for further evaluation of apparent infiltrates on chest radiograph and treatment of dehydration. A nasopharyngeal PCR test for SARS-CoV-2 was negative on the day of admission, and a chest CT was reported as normal. The participant was discharged from the hospital 2 days after admission. With chest imaging findings that are difficult to reconcile, it is possible that this event represented reactogenicity following the second vaccination, a COVID-19 case with false negative test that occurred less than 7 days after completion of the vaccination series, or an unrelated infectious process. In the other case, a 66-year-old male with no medical comorbidities experienced fever, myalgias, and shortness of breath beginning 28 days post-Dose 2 and was hospitalized one day later with abnormal chest CT showing a small left-sided consolidation. He was discharged from the hospital 2 days later, and multiple nasopharyngeal PCR tests collected over a 10-day period beginning 2 days after symptom onset were negative. It is possible, though highly unlikely, that this event represents a COVID-19 case with multiple false negative tests that occurred more than 7 days after completion of the vaccination regimen, and more likely that it represents an unrelated infectious process. Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.
感觉那个写手故意断章取义，误导听众。两例严重的都说得很仔细。一例是打第二针当天有反应，3天后住院，PCR阴性，肺CT没异常。怀疑是疫苗严重反应。另一类老人更严重点，住院10天。多次PCR 都是阴性。一次假阴性可能性可能，10天内多次假阴性的可能极低。
那个很多疑似的标准很低，疫苗组人数比安慰组还多，更大的怀疑是疫苗本身的反应，而不是假阴性
-------------------------
As specified in the protocol, suspected cases of symptomatic COVID-19 that
were not PCRconfirmed were not recorded as adverse events unless they met
regulatory criteria for
seriousness. Two serious cases of suspected but unconfirmed COVID-19 were
reported, both in
the vaccine group, and narratives were reviewed. In one case, a 36-year-old male with no
medical comorbidities experienced fever, malaise, nausea, headache and
myalgias beginning
on the day of Dose 2 and was hospitalized 3 days later for further
evaluation of apparent
infiltrates on chest radiograph and treatment of dehydration. A
nasopharyngeal PCR test for
SARS-CoV-2 was negative on the day of admission, and a chest CT was reported as normal.
The participant was discharged from the hospital 2 days after admission.
With chest imaging
findings that are difficult to reconcile, it is possible that this event
represented reactogenicity
following the second vaccination, a COVID-19 case with false negative test
that occurred less
than 7 days after completion of the vaccination series, or an unrelated
infectious process. In the
other case, a 66-year-old male with no medical comorbidities experienced
fever, myalgias, and
shortness of breath beginning 28 days post-Dose 2 and was hospitalized one
day later with
abnormal chest CT showing a small left-sided consolidation. He was
discharged from the
hospital 2 days later, and multiple nasopharyngeal PCR tests collected over a 10-day period
beginning 2 days after symptom onset were negative. It is possible, though
highly unlikely, that
this event represents a COVID-19 case with multiple false negative tests
that occurred more
than 7 days after completion of the vaccination regimen, and more likely
that it represents an
unrelated infectious process.
Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study
population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected
COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine
group vs. 287 in the placebo group. It is possible that the imbalance in
suspected COVID-19
cases occurring in the 7 days postvaccination represents vaccine
reactogenicity with symptoms
that overlap with those of COVID-19. Overall though, these data do not raise a concern that
protocol-specified reporting of suspected, but unconfirmed COVID-19 cases
could have masked
clinically significant adverse events that would not have otherwise been
detected.