When President Trump announced “Operation Warp Speed” he claimed we might have a vaccine to fight SARS-CoV-2 within six months. I chuckled and wondered if Captain Kirk was going to get Dr. McCoy to beam something back from the future. Almost as unrealistic as that is the idea that a safe and effective vaccine could be developed within six months.
The CDC says that it takes several years to make a vaccine and their link to historyofvaccines.org explains the vaccine process in detail. Vaccine production requires human clinical trials and they can only be started after the exploratory and pre-clinical phases. Animal experiments must come before human experiments which can’t be rushed because it takes time to monitor for immediate and delayed side effects. Then more time is needed to determine efficacy. All this takes several years.
The only way to get a vaccine approved and produced in six months is to bypass a lot of the pre-clinical phases and rush through the clinical trials. A lot of pharmaceutical and biotech companies will be jumping at the chance to get warp- speed funding for their warp-speed trials.
Moderna seems to have a head start on all of them because one of their board members and heavy investors is Moncep Slaoui who was appointed by President Trump to lead the Warp Speed vaccine project. Moderna is a very interesting company with a unique concept. Their proposed vaccines and future medicines rely on their ability to manufacture genetic codes in the form of mRNA which they want to deliver into a human. The mRNA code is taken into cells which make a new protein. Their Coronavirus vaccine will consist of injected mRNA that tells your cells to make the unique Coronavirus spike protein which will then be recognized by your body so that you make antibodies. The antibodies are supposed to be protective in case you encounter the real SARS-CoV-2.
Is it safe? Will it work? We are about to find out because Moderna is ready to start their Phase 2 trial. They had already been approved by Dr. Anthony Fauci at the NIAID to start a Phase 1 trial back on March 16th. That means that prior to March 16th Moderna must have already done enough research with animal testing to get approval, right? When did Moderna do all that stuff? I mean, Dr. Fauci keeps saying that we still don’t know much about the novel SARS-CoV-2.
Moderna’s webpage explains that the “first clinical batch, which was funded by CEPI, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.”
So, they had 63 days prior to February 7th to do their animal studies. Is that enough time to organize and test a completely different type of vaccine? Did they do animal studies at all? I doubt it. More likely, they relied on prior studies done on a different mRNA molecule derived from the first SARS or MERS. Stay tuned.
The speed with which Moderna was able to move is amazing and it makes me uneasy. Even more amazing is that the CEO of CEPI (one of the funders of the “first batch”) Dr. Richard Hackett was almost clairvoyant because as early as JANUARY 17th, just two days after the first deaths were reported in China, he was already thinking of ways to get out a vaccine.
The bottom line is that there is a lot of momentum to push through a Coronavirus vaccine. There are literally billions of dollars on the table. The stage is set for conflicts, corruption and bad science with the possible outcome being an unsafe and ineffective vaccine.
I recommend extreme caution before you ever decide to get any Warp-Speed vaccine.
We are screening all our patients carefully to ensure that you will be safe here. We are open and seeing patients in the office. For those with COVID symptoms, can easily provide consultations over the phone or by video.