Ah, Liz Szabo. Now writing directly for Kaiser Health. How many of us have been interviewed her in the past? I was for nearly two hours many years ago. I'm pretty sure she channeled Harry Potter's Rita Skeeter and used some sort of Weasley Brothers Mix'emUp translation writing system when "my words" finally made the paper.
Can you imagine if the short-short-short terms results, so short they make the Oompah Loompahs look like Jolly Orange Giants are considered "so good" that the Data and Safety Monitoring board would green light the vaccine to the American public before testing is complete? As a moral obligation, no less. Watch it happen. And then when medium and long term data comes in - it will be too late for recipients to turn back. If the trial is stopped early, do the pregnancy criteria for the Moderna vaccine as an example cease to matter? Moderna, a company that has never brought a product to market. If recipients become pregnant or impregnate their partner, will we usher in The Age of Covax?
Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 60 days after the last vaccination.
Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception
True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products.
Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination.
Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination. Source Clinicaltrials.gov###
By Liz Szabo September 1, 2020, Kaiser Health
A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci, the nation’s top infectious disease official, in an interview Tuesday with KHN.
Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.
The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions. Read more at Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming