A third wave of coronavirus cases continues to crest around the world, but positive news came of working vaccines from two drug manufacturers — one of which has applied for emergency approval from the Food and Drug Administration. The first vaccines should be available in Santa Barbara County as early as the end of the year, the county’s Health Officer Dr. Henning Ansorg announced on November 13.
Today Pfizer released the news that it had submitted its BNT162b2 vaccine for emergency use authorization (EUA) to the Food and Drug Administration, the same emergency process that has allowed virus test kits of varying efficacy to enter the market. Pfizer stated that once the authorization was approved, it would be ready to ship the drug “within hours,” with the timeframe most likely by mid- to late-December. It expects to produce 50 million doses this year, and 1.3 billion by the end of 2021, with global distribution. Pfizer’s partner in the vaccine development is BioNTech of Germany.
Moderna, the second manufacturer to announce a vaccine, stated its vaccine was 95 percent effective and that it would apply for an EUA within two weeks. Pfizer’s is said to be equally efficacious, but must be stored at much colder sub-zero temperatures than Moderna’s.
Santa Barbara County’s Public Health department stated that not only are those two vaccines soon to be available, but study results were expected from vaccines being tested by AstroZeneca and Johnson & Johnson. “Right now, it appears that the Pfizer vaccine will be the first available, with the Moderna following closely behind,” members of the county’s Emergency Preparedness Program wrote in an email.
The Pfizer trial involved 38,000 people who took the second dose of the vaccine — it is a two-dose vaccination — including 100 children 12-15 years of age. Among U.S. participants, 30 percent were of varied racial and ethnic backgrounds. Moderna’s study was in collaboration with the National Institutes of Health and the FDA, and its 30,000 participants included more than 7,000 people who were over the age of 65; 42 percent of all participants were in high-risk groups; and 11,000 were from communities of color.
The third phase of the drug trials for both companies started in July, and the people receiving the second dose are to be followed for two years. Participants were told to respect the usual COVID-19 protocols, a Pfizer representative stated, such as wearing a facemask, washing their hands frequently, and avoiding crowded places. Pfizer’s study results showed 170 people came down with COVID out of the 38,000 participants — who spanned the globe — 162 of them in the placebo group. Ten had severe cases, one of which was in the vaccinated group. No deaths occurred, and about 2 percent of people reported side effects of fatigue or headache.
County Public Health’s Emergency Preparedness Program has been organizing a vaccine campaign. The first people to receive the shot in either late December or early January would be “high-risk health-care workers, including hospital, skilled nursing, and assisted living workers, and first responders; and the next for individuals at highest risk for developing severe illness, such as residents of skilled nursing and assisted living facilities.”
Public Health is now counting heads to know how many people that comprises. Some state funding has come in to help with the initial set of vaccinations, but more funding will be necessary to vaccinate everyone in the county. The phases of the vaccination at large is still being coordinated with California’s public health department.
Logistically, transporting, storing, and handling the vaccine present challenges. The Pfizer vaccine requires an ultra-low temperature of minus-70 degrees Fahrenheit, and the Moderna vaccine requires minus-2 degrees F. Guidance on handling and administering the fragile vaccines was still being written, the preparedness group said.
The vaccine itself would be free, they added, but private doctors would be able to charge for the cost of giving the shot.
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