Slouching Towards Oblivion

Monday, November 23, 2020

COVID-19 Update

World
New Cases:   489,379 (⬆︎ .83%)
New Deaths:      7,415 (⬆︎ .53%)

USA
New Cases:   137,010 (⬆︎ 1.12%)
New Deaths:         871 (⬆︎   .33%)

First time in 11 days we've been below 150,000 new cases. But hey - it's the weekend.
We've been over 100,000 new cases every day day for 20 days in a row.





What you need to know about the Moderna and Pfizer coronavirus vaccines

Both appear to be more than 90 percent effective in clinical trials and could begin to be available before the end of the year.

The vaccines are made by different companies: One is being developed by pharmaceutical giant Pfizer and its German partner, BioNTech, and the other by biotechnology firm Moderna, in partnership with the National Institute of Allergy and Infectious Diseases. Both drugmakers have moved at record speed and will seek regulatory clearance for their vaccines in the coming weeks.

What Happens Next
Companies will apply to federal regulators for authorization to provide the vaccines more broadly.

FDA regulators will review the effectiveness, safety and manufacturing of each vaccine.

An FDA advisory committee will vote on whether to recommend that the agency greenlight each vaccine.

December
The FDA may authorize one or both vaccines.

One or two days later
A Centers for Disease Control and Prevention advisory committee will discuss prioritizing vaccines for high-risk groups.

End of 2020
The government projects that Pfizer and Moderna will provide 40 million doses, enough for 20 million people, by the end of the year.

Why is the FDA using emergency powers to approve a vaccine?

The FDA has emergency authority to issue temporary approvals of medical products to get them to the public more quickly during public health emergencies. Such authorizations require less data and can be done more rapidly than full approvals. Since February, the FDA has used this power to authorize hundreds of coronavirus tests and a few treatments. But it has authorized a vaccine that way only once in its history — in 2005, against anthrax — and that was under sharply different circumstances.

Some experts have expressed qualms about using that process for a coronavirus vaccine that would be given to hundreds of millions of people, but those criticisms have become muted as the pandemic has raged, killing thousands of Americans a week.

Peter Marks, director of the FDA center that oversees vaccines, has vowed to insist on an emergency standard for a vaccine that is roughly equivalent to what’s needed for a full licensure. Even so, the available safety data — two months follow-up on half the trials’ participants after their second shots — is shorter than in traditional trials. And some questions, such as the duration of protection, can’t be answered now — that data will be collected as the trials continue.

When will I be able to get vaccinated?
That depends on your job, your age and your health.

The vaccines could begin to be distributed as soon as late December to those in high-risk groups — an estimated 200 million people — who will receive priority, according to a framework devised by an advisory committee to the Centers for Disease Control and Prevention. Government officials said that if both vaccines are authorized, they anticipate having enough doses for 20 million people by year’s end.

The exact criteria for who will be first in line will be defined immediately after a vaccine is authorized, but the general principles have been discussed for months. You may qualify for earlier access because of your job: Health-care workers and first responders are likely to be among those prioritized. People who have essential jobs, such as teachers and food workers; those who are at higher risk because of their age; and those who have underlying conditions that increase their risk for severe disease are also likely to receive earlier access.

Healthy younger adults who don’t have medical conditions or high-risk jobs are likely to begin to get vaccinated starting in April, but not everyone will be able to get the shots immediately. And children aren’t even included in most coronavirus vaccine trials — Pfizer is the first company to expand its trial to people 12 and older — so they probably will be among the last to get access.

“I would say starting in April, May, June, July — as we get into the late spring and early summer — that people in the so-called general population, who do not have underlying conditions or other designations that would make them priority, could get” shots, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.
How will the vaccines be shipped?

The Moderna vaccine is stored frozen at minus-20 degrees Celsius, but it keeps for a month at refrigerator temperatures. This could make it easier to distribute to pharmacies and to rural areas that don’t have specialized freezers.

The vaccine from Pfizer and BioNTech must be kept at an ultracold, minus-70 degrees Celsius. The company has created its own GPS-tracked coolers filled with dry ice to distribute it.


Each vial of the Pfizer vaccine holds five doses when diluted. Once thawed, the undiluted vial can be kept in a refrigerator for only five days. A diluted vial can be kept for only six hours before it must be discarded.

How many doses will I need?
Both vaccines require two doses. Pfizer’s booster shot will be given three weeks after the first one; Moderna’s is spaced four weeks later.

How do the vaccines work?
If cleared, these two will be the first vaccines using messenger RNA technology ever approved for human use by the Food and Drug Administration. It is different from more traditional vaccines, which often use a weakened or dead version of a virus, or a laboratory-generated protein. Both vaccines use a snippet of the virus’s genetic code to instruct cells to build the spike protein on the surface of the coronavirus, teaching the immune system to recognize the real thing.

There's a whole bunch more info in the piece at WaPo, and they've lifted their pay wall for articles dealing with the coronavirus.

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