Operation Warp Speed is running at full speed Monday, after the first COVID-19 vaccine developed by Pfizer (PFE) and BioNTech (BNTX) was shipped to sites across the U.S. over the weekend, launching the biggest mass vaccination campaign since polio.
The two-dose novel coronavirus vaccine, of which 2.9 million doses will be delivered in the first round to health workers and nursing home residents, is the first mRNA vaccine to be used on the market. The new technology requires significantly lower temperatures for storage, but its high efficacy rate has given hope that a second generation of vaccines using the same platform — and adjusting the cold storage needs— could set the trend for future vaccines.
While the federal government didn’t invest in the development of the vaccine, it did support the needs — including sending vaccine kits and helping with the shipments of the vaccines— of the companies.
To-date, Operation Warp Speed (OWS) has invested more than $10 billion in the vaccine race, according to U.S. Health Sec. Alex Azar.
Azar said Monday, “Today, Americans around the country will begin receiving a (FDA) authorized authorized COVID-19 vaccine. This historic moment is a remind to all of us to redouble our efforts to practice good behaviors to keep ourselves and our loved ones safe.”
The emergency use authorization (EUA) for the vaccine came just a day after thee U.S. Food and Drug Administration’s (FDA) advisory panel recommended as much — but not before reports of White House pressure on FDA Commissioner Stephen Hahn to authorize Friday or resign. Previously, the FDA’s top vaccine expert Dr. Peter Marks had said it could take “days to a week” to authorize the shot.
As the vaccine reaches the designated 636 sites in 64 public health jurisdictions, the FDA is ramping up for another potential authorization this week or next - this time from Moderna (MRNA).
Moderna’s vaccine, using a similar platform as Pfizer but with less intense cold storage needs, was developed in close coordination with the National Institutes of Health. The U.S. purchased 100 million more doses of the vaccine last week, on top of an initial 100 million purchase. The announcement came after controversy over the U.S.’s refusal to purchase additional Pfizer vaccines in the summer. The meeting is scheduled for Thursday. Moderna also said Monday it expects approval of the vaccine in Europe on January 12.
Meanwhile, other vaccines are still in play, but their timelines are less clear. AstraZeneca’s (AZN) vaccine, developed by Oxford University, has garnered some doubt over its vaccine when it unintentionally tested two different dosing regimens. The company hopes the FDA will review and authorize the vaccine in January, but the FDA has given no indication.
National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci told the Journal of the American Medical Association (JAMA) on Friday that he expects Johnson & Johnson (JNJ) to have its vaccine out by March, just as the U.S. would ideally be gearing up to vaccinate the general publicly, followed by Novavax (NVAX). He addressed AstraZeneca as an afterthought, noting it was still in the running.
J&J’s vaccine differs from other frontrunners in that it is a single dose shot and requires no special refrigeration, which holds significant potential for global distribution. The Phase 3 trial is ongoing and was recently capped at 40,000, though it originally targeted 60,000, due to the high prevalence of the virus in trial areas.
Meanwhile, nursing homes are preparing for the first shots to be delivered next week, on December 21, by Walgreens (WBA) and CVS (CVS) pharmacies.
The news of the first vaccine authorization comes as the country endures ongoing surges as the aftermath of Thanksgiving travel is still being seen. Daily case counts continue to rise, with a new record of 247,000 on Friday. Hospitalizations have surged to 109,000 and are expected to continue in the coming week.
Health experts are concerned that just as the full picture from Thanksgiving travel and gatherings unfold, Hanukkah is here and Christmas and New Year’s are around the corner — which could lead to increased travel and cases again.
On Monday, New York City Mayor Bill DeBlasio said the city should prepare for the possibility of another full shutdown, as it had done earlier this year.
First human challenge trials, nasal vaccine trials
Meanwhile, the U.K. is expected to begin its first human challenge trial in 2021, in addition to the first nasal
OpenOrphan (ORPH.L), parent company of clinical trial platform hVIVO, announced Monday the U.K.’s Medicine and Healthcare Products Regulatory Agency (MHRA) approved the Phase 1 study of the vaccine by U.S. biotech Codagenix, which is also collaborating with the Serum Institute of India — the world’s largest vaccine manufacturer.
The vaccine, delivered through the nose, uses a weakened form of the coronavirus and will be tested on 48 healthy young adults in Phase 1.
Codagenix chief medical officer Sybil Tasker said in a statement, “We believe COVI-VAC, a needle-free, single dose vaccine is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first-generation COVID-19 vaccines.”
While the companies have not shared if this trial would be part of Open Orphan’s human challenge trials, but the first phase is not a challenge. OpenOrphan is preparing to begin testing the method in January as well. The controversial trial method is said, by advocates, to be a quicker and safe method of testing a vaccine.
More from Anjalee:
Fauci: Vaccines will only prevent symptoms, not block the virus
Biden COVID-19 adviser: Vaccine news is great, but we still have a ways to go
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