Covering COVID-19 is a daily Poynter briefing of story ideas about the coronavirus and other timely topics for journalists, written by senior faculty Al Tompkins. Sign up here to have it delivered to your inbox every weekday morning.
Pfizer and the U.S. Food and Drug Administration released the most detailed information to date about the vaccine that the drug company wants the FDA to approve this week. The data is largely encouraging.
It comes from 38,000 drug trial volunteers, a far higher number compared to the original data release, yet the findings from the first release remain consistent.
Within seven days of the second dose of the vaccine, 95% of patients produced enough antibodies to protect them from COVID-19 infection. And, the study says, the study produced the same good results across races, ethnicities and age groups.
Also encouraging, the Pfizer data shows that even a week after receiving the first of the two doses, patients showed some immunity to the coronavirus. The researchers say they believe the vaccines will be effective for 16- to 17-year-olds but cannot say yet how children will react to the vaccine.
The new data shows that yes, the shots do produce some side effects like pain, headaches and chills. Less than 5% of patients reported “severe” reactions. The Pfizer report says:
The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%); severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after Dose 2 than after Dose 1.
I spoke with some of the experts who will join me for our Covering Vaccines webinar on Monday who winced at the description of “adverse reactions.” They reminded me that the reactions are from your body building immunity. Far from being adverse, the reactions are an indication that the vaccine is doing what it is supposed to do: build up your immune defenses.
What you need to know about the FDA meeting tomorrow
Some people are calling Thursday’s meeting of an FDA advisory committee the most important FDA hearing in the history of the agency. That is quite a statement, and it may just be true.
The scientists who will be meeting are from the Center for Biologics Evaluation and Research and the Vaccines and Related Biological Products Advisory Committee, commonly shortened to CBER and VRBPAC.
CBER is the center within FDA that “ensures that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.” See a list of CBER members here.
VRBPAC is a 15-person committee that “reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility.” See a list of VRBPAC members here.
The VRBPAC committee members represent a wide range of scientific expertise, including immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology and biochemistry.
The committee has two decisions to consider:
- Based on the totality of scientific evidence available, is it reasonable to believe that the Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older?
- Whether the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its known and potential risks for use in individuals 16 years of age and older.
The committee will vote Thursday evening and send its recommendations to the FDA, most likely Thursday night. It is possible that the FDA could even approve the vaccine for distribution on Thursday, and then distribution could begin. It is also possible that the vaccines could be distributed with 24 hours, meaning late Friday or over the weekend.
Of course, the committee and the FDA could move at whatever speed they choose, but will likely act fast given the strong data just released.
The Thursday meeting starts at 9 a.m. and may run until 6 p.m. You will be able to access it on YouTube, Twitter and directly from the FDA.
News about the other drugs
Initial details about the other drugs that will be coming before the FDA soon are mostly positive.
Moderna will be about a week behind Pfizer in seeking FDA approval for its vaccine. It has produced similarly positive results so far.
A third drug, from AstraZeneca and Oxford University, appears safe and about 70% effective, according to early test results from the United Kingdom and Brazil. But that report, in the medical journal Lancet, leaves some questions as to how effective it is in preventing COVID-19 infections in patients over age 55.
How will you schedule your vaccination?
A CVS store on 5th Avenue in Manhattan. (STRF/STAR MAX/IPx)
CVS’s CEO explained at the White House vaccine summit Tuesday that when it is time for you to get a COVID-19 vaccine, you will be able to go online and make an appointment. You will be able to book a time and date for both the first and the second dose. People who go to one place for the first dose and another place for the second dose will be asked what pharmaceutical company produced their first dose.
Pfizer estimates that each immunization should take 10 minutes.
When you get your first shot, you will be given a reminder about when you are supposed to get your second dose. Texas Gov. Greg Abbott said he wanted to stress that patients will be given a reminder card but that the reminder is not a “national vaccine card” and “nobody will be forced” to take the vaccine. And he said there will be no “national register” of who has or has not been vaccinated.
CVS says it estimates that it can deliver 25 million vaccinations per week. It does not anticipate lines for people waiting to get shots because people will have appointments and, if they miss their appointment, they will get a call to make a new one. CVS says it will send text messages, phone calls or emails to people to remind them of their appointments.
Walgreens has similar plans. The main message is that these two drugstore chains will be critically important in delivering COVID-19 vaccines across America. They already deliver millions of vaccines every year for the seasonal flu and shingles.
States have different plans
USA Today is tracking how states have very different plans to distribute the first vaccines:
Mississippi said it was getting 3,000 doses, which is about right for its 1% of the U.S. population. Texas Gov. Greg Abbott said on Thursday his state had been allotted 1.4 million doses for the month of December but didn’t say how many would come in the first shipment. Wisconsin on Wednesday offered a very specific first dose shipment of 49,725 doses.
In Kentucky, two-thirds of its vaccine allotment will go to residents and workers in long-term care centers while one-third will go to people working in hospital COVID-19 units. Gov. Andy Beshear said he is focusing on long-term care because that accounts for about 65% of all COVID-19 related deaths in Kentucky.
In Indiana, hospital chaplains will be included among the first to get the vaccine, while in Tennessee health care workers 65 and older will go to the front of the line.
In Florida, the first round of vaccine will go to five designated hospitals in Orlando, Miami, Tampa, Jacksonville and Hollywood. Immunizations will be provided for health care workers at those hospitals and for those who work elsewhere.
Illinois will receive the first shipments of vaccine centrally and then redistribute it to local health departments, to ensure it’s equitably allocated to all jurisdictions, said Melaney Arnold, with the Illinois Public Health Department.
Utah is prioritizing health care workers in its five largest hospitals as they’re treating the largest proportion of COVID-19 patients. As more vaccine becomes available, it will expand to other hospitals and clinic settings, said Tom Hudachko, director of communications with the Utah Department of Health.
In Alaska 80% of communities are only accessible by air or water and most vaccine must be distributed by plane. It has a centralized vaccine depot in Anchorage.
Oklahoma is going for a hub and spoke model. Strategically located sites with ultra-cold storage capability will get the first shipments and vaccine will be redistributed from those locations through county health departments. For security purposes, the state won’t say where the pre-positioned vaccine will be stored.
Ohio has designated 10 hospitals in the state to serve as pre-positioning sites, all helpfully listed on the state Department of Health’s website, along with a map.
USA Today’s exhaustive survey of state preparedness takes into consideration that vaccinations will be rolling out when winter weather is at its most severe, so outdoor vaccination sites won’t be an option. USA Today’s work was the product of 47 journalists who contributed details. Fantastic work.
Will the federal government be keeping your COVID-19 vaccine data?
The Centers for Disease Control and Prevention is telling states to sign data use agreements that would commit them to sharing personal information with the federal government. It would be the first time states would promise to turn over such data.
The last thing we need is a disincentive for people to get vaccinated or to light the fuse on another conspiracy rumor, but this has all of the makings of both.
New York Gov. Andrew Cuomo said he was concerned that the federal government would hand personal data from the vaccination program to Immigration and Customs Enforcement and use the information to go after people who are not in the country legally.
Administration officials say that the information will not be shared with other federal agencies and that it is “critically necessary” for several reasons: to ensure that people who move across state lines receive their follow-up doses; to track adverse reactions and address safety issues; and to assess the effectiveness of the vaccine among different demographic groups.
“This is a new activity for us, as we don’t typically report this level of detail on this frequency to the federal government,” Doug Schultz, a spokesman for the Minnesota Department of Health, said in an email. He added, “We will not be reporting name, ZIP code, race, ethnicity or address.”
Tracking immunizations, including collecting personal data, is not a new practice, and experts say it is especially important with a vaccine that requires two doses. But in the United States, it has been a purely state-by-state effort. A push two decades ago to develop a federal registry imploded after an uproar over patient privacy and how the data would be used.
In the agreement, the CDC says it needs the data to understand what populations are getting the vaccine and where there are “pockets of under-vaccinations.” The data, the CDC agreement says, is also important to track the vaccine’s effectiveness and safety in the long term.
HHS answers questions from governors
The U.S. Department of Health and Human Services tried to answer a range of questions that governors are raising about who is going to pay for all of the logistical costs of this national vaccination program.
In a memo to governors, HHS said that before Dec. 15, the federal government will allocate another $140 million to states in addition to the $200 million Operation Warp Speed has sent to states already.
HHS reminded governors that the federal government is already paying the preponderance of costs for the vaccination effort, including:
- Securing vaccines and most accompanying supplies will cost the state nothing as these are paid for by the federal government;
- Almost all transportation of a vaccine is covered, either through the manufacturer or through McKesson, the contractor being paid to move the vaccine to administration sites throughout the country;
- Providers who administer the vaccine will be paid through insurance reimbursement under Medicare and Medicaid, or private coverage;
- Healthcare providers who vaccinate uninsured persons will receive reimbursement through the federal uninsured fund managed by Health Resources and Services Administration (HRSA), which has already been covering the cost of care for uninsured COVID-19 patients;
- Training for most of the healthcare provider workforce to administer the vaccine will be covered in large part by their employing institutions, be it hospitals, pharmacy chains, or other large healthcare entities.
Will COVID-19 vaccines require parental approval?
Let’s say you are a teen and your parent is an anti-vaxxer. Can you get a COVID-19 vaccine without parental approval? This issue is playing out in Washington, D.C., where a bill that arose before the pandemic now has added importance. DCist reports:
Groups of parents, advocates and activists are urging D.C. Mayor Muriel Bowser to veto a bill passed by the D.C. Council last month that would allow kids as young as 11 to seek vaccines without a parent’s consent.
Their push comes as cities and states across the U.S. prepare to distribute the much-awaited COVID-19 vaccine, and touches on flashpoints around required vaccinations, herd immunity, racial discrimination in healthcare and, for some, the spurious claims that routine vaccinations are harmful to people’s health.
As written, the bill would allow minors to seek a doctor’s approval to get common vaccines endorsed by the Centers for Disease Control and Prevention. The doctor would need to verify that the minor “is able to comprehend the need for, the nature of, and any significant risks ordinarily inherent in the medical care.”
D.C. already allows minors above the age of 12 to consent to a range of health services, including contraceptive services, mental health, prenatal care, and abortions; a handful of states currently allow minors of varying ages to access certain vaccines without their parent’s consent.
My thanks to reader and good friend Jim Sweeney for spotting this item and sending it along to me.
The vaccines are just part of the challenge
Workers unload a FedEx truck. (STRF/STAR MAX/IPx)
Both FedEx and UPS said Tuesday that they have plenty of capacity to move all of the vaccines and supplies that America will need.
CNBC reported Tuesday that for every pallet of vaccines that the delivery companies have to move, there are 25 to 30 pallets of supporting materials that have to go with them. They include everything necessary for vaccinations, from gloves to syringes. The demand will be so big, on top of holiday shipping and the additional shipping that has come with the pandemic, that you may see shipping prices go up.
Dry ice supplies
A worker demonstrates how a temperature sensitive shipment of medicine or a vaccine is kept cold with dry ice at the Swissport Pharma Center in Machelen, Belgium, Wednesday, Nov. 25, 2020. (AP Photo/Virginia Mayo)
As you know, the Pfizer vaccine has to be shipped and stored at extremely low temperatures, which is creating a huge demand for dry ice supplies. The Compressed Gas Association, which includes dry ice manufacturers, says there probably will be enough dry ice to get the job done. There was a significant shortage of dry ice earlier this year. GasWorld, an industry website, says:
“According to CGA members, the current production capacity for carbon dioxide and dry ice is expected to be sufficient to meet anticipated demand from vaccine manufacturers,” CGA said in a post on its website.
“There is also potential capacity to increase production and distribution of dry ice for Covid-19 vaccines, if needed. CGA members report that the carbon dioxide production capacity in the US and Canada is 30,000 to 35,000 tonnes per day.”
How people spent the last stimulus money, and what they would do with a second check
The Federal Reserve Bank asked 1,300 households how they used the first round of 2020 stimulus checks, which averaged $2,400. The survey found:
- 36% of stimulus payments were saved.
- 35% of the money was used to pay down debt.
- 18% of the funds were used for essential spending, such as necessary daily living expenses.
- 8% used for nonessential spending, such as hobbies, leisure, vacation, and other items respondents do not need.
- 3% of the funds were donated.
Yahoo Finance asked people to predict how they would spend a second stimulus check, if one is forthcoming. The responses:
- 53% of the surveyed said they would use part of the check to pay down bills.
- 43% said they would spend it on essentials.
- 39% said they would put it toward savings.
- 30% would use it to cover rent or a mortgage.
- 22% would spend it on holiday gifts.
The way we live now
I put this on the porch yesterday and I’ve had the best time watching delivery drivers go ‘ohh!’ when they come to the porch all morning. Highly recommend for increasing holiday spirit. pic.twitter.com/lnYncFm4FR
— Julie DiCaro wrote a book (@JulieDiCaro) December 6, 2020
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