Here’s how the U.S. government plans to distribute the first Covid-19 vaccines.

In the wake of a steady stream of positive results indicating the effectiveness of several coronavirus vaccines, the official in charge of the federal coronavirus vaccine program explained on Sunday news shows how the vaccines might be distributed to Americans as early as next month.

Dr. Moncef Slaoui, head of the administration’s Operation Warp Speed, said that within 24 hours after the Food and Drug Administration approves a vaccine, doses will be shipped to states to be distributed. “Within 48 hours from approval,” the first people would likely receive injections, Dr. Slaoui said on ABC’s “This Week With George Stephanopoulos.”

Two companies, Pfizer and Moderna, announced this month that their vaccines were about 95 percent effective, and Pfizer formally submitted an application to the F.D.A. for emergency approval. Regulators at the agency will spend about three weeks reviewing the application. On Dec. 10, an outside advisory board on vaccines will meet to discuss the application, and the agency is expected to make a decision shortly after that meeting. Moderna is expected to submit its own application soon.

Even if the first vaccine is authorized in mid-December, officials and company representatives have estimated that there will only be enough doses available to treat about 22.5 million Americans by January. Each vaccine requires two doses, separated by several weeks.

Dr. Slaoui said vaccines would be shipped to states, proportioned according to their population, and that states would decide how and where to distribute the doses. He said that likely within a day after a vaccine receives F.D.A. authorization, a committee at the Centers for Disease Control and Prevention would issue recommendations for which groups should be first to receive a vaccine.

High-priority groups are likely to include frontline medical workers and residents of nursing homes. Dr. Scott Gottlieb, a former F.D.A. commissioner, said on the CBS show “Face the Nation” that those groups would likely be followed by other older adults and then expanded to younger adults in the spring. Both he and Dr. Slaoui estimated that tens of millions of adults could be vaccinated by sometime in May.

Immunizations for children would follow. Dr. Slaoui said on the CNN show “State of the Union” that the youngest participants in the clinical trials so far have been 12 to 14 years old and that approval for younger children and toddlers would likely not occur until late in 2021, after clinical trials for those age groups are conducted.

On “Face the Nation,” Larry Merlo, the chief executive of CVS Health, said that pharmacists and other medical staff from CVS plan to immunize residents of more than 25,000 long-term care facilities, beginning about 48 hours after a vaccine is approved. He said that for several years, CVS has been going to nursing homes to administer the seasonal flu vaccine, so “we have the systems, we have the processes, and we have built the logistics directly for the Covid vaccine.”

Mr. Merlo, whose company runs 10,000 pharmacies across the country, also said as the supply

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3 Things About Coronavirus Vaccines That You Almost Certainly Won’t Like

Anticipation is building for the first coronavirus vaccines to become available to Americans. Four drugmakers are currently conducting late-stage clinical studies for experimental COVID-19 vaccines, with a fifth company planning to begin late-stage testing of its vaccine candidate by the end of November.

The arrival of one or more safe and effective vaccines will definitely be a major milestone in the battle to control the COVID-19 pandemic. However, these vaccines won’t be everything that everyone wants them to be. Here are three things about the coronavirus vaccines that could be on the way that you almost certainly won’t like.

Thumb down next to an arm with "vaccinated" stamped on it

Image source: Getty Images.

1. They won’t be 100% effective

Let’s assume that Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) report great results and win FDA emergency use authorization for their COVID-19 vaccine BNT162b2 before the end of this year. Suppose that Moderna (NASDAQ:MRNA) also secures EUA for its vaccine, mRNA-1273. At some point over the following months in this hypothetical scenario, you would be able to receive one of these vaccines (or one of the other leading candidates that might make it to market).

After you’re vaccinated, you won’t have to worry about getting COVID-19, right? Think again. It’s a virtual certainty that none of the vaccines will be 100% effective. Unfortunately, there’s a decent chance that you could receive a coronavirus vaccine yet still be diagnosed with COVID-19.

The FDA’s threshold for efficacy is actually pretty low — only 50%.Sure, we all hope that the coronavirus vaccines that become available to Americans are a whole lot more effective than flipping a coin. However, there’s no guarantee that will be the case.

2. You might have to take two doses

No one likes to get a vaccine shot. It’s a hassle to go to your healthcare provider to be vaccinated. Having a needle stuck in your arm isn’t fun. You also face the possibility of side effects, some of which can make you feel especially crummy.

Now take all of those negatives and double them. There’s a very good chance that you’ll have to receive two doses of a COVID-19 vaccine, one dose several weeks after the first dose. 

Pfizer’s and BioNTech’s coronavirus vaccine requires two doses. So does Moderna’s vaccine. Ditto for the COVID-19 vaccines being developed by AstraZeneca (NASDAQ:AZN) and Novavax (NASDAQ:NVAX). Of the leaders in the coronavirus vaccine race, only Johnson & Johnson‘s (NYSE:JNJ) JNJ-78436735 is a one-and-done option.

J&J is lagging behind Pfizer/BioNTech, Moderna, and AstraZeneca, though. Why? Because it started late-stage testing after the others and had to temporarily pause its study due to a potential safety issue (one that didn’t turn out to be a problem after further investigation). If these companies’ coronavirus vaccines win EUA, you could end up receiving one of them before J&J’s vaccine is available. 

3. They’ll likely be the new normal

Some Americans might envision a not-too-distant future where COVID-19 is a thing of the past. No vaccines, no masks, no problems. The masks probably won’t be necessary down

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States say they lack federal funds to distribute coronavirus vaccines as CDC tells them to be ready by Nov. 15

State officials have been planning in earnest in recent weeks to get shots into arms even though no one knows which vaccine will be authorized by the Food and Drug Administration, what special storage and handling may be required and how many doses each state will receive.

Despite those uncertainties, the Centers for Disease Control and Prevention is asking states to be prepared to “preposition” doses in key locations throughout the country. Officials want to move quickly once the FDA authorizes a vaccine and a CDC advisory panel issues recommendations on which populations should be vaccinated, according to a letter the CDC sent Monday to state preparedness and immunization officials.

As part of that effort, the CDC is asking states to provide by Tuesday critical information, including a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine that must be stored at ultracold temperatures of minus-70 Celsius (minus-94 Fahrenheit). The letter refers to the vaccine only as Vaccine A, but industry and health officials have identified it as Pfizer’s candidate.

Pfizer chief executive Albert Bourla said Tuesday that “hundreds of thousands” of doses had already been produced and that a first look at the data would occur soon. Pfizer will not apply for any authorization of its vaccine sooner than the third week of November, when it will have sufficient safety data.

“We acknowledge that you are being asked to do unprecedented work,” wrote Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, which is leading the CDC’s role in vaccine distribution. She added: “This is a new planning ask.”

State officials say they have been trying to raise the issue with federal officials but have received little response.

“It is absolutely ridiculous that the administration, after spending $10 billion for a Warp Speed effort to develop a vaccine, has no interest in a similar investment in a Warp Speed campaign to get the vaccine to every American as quickly as possible after it is approved,” said Michael Fraser, executive director of the Association of State and Territorial Health Officials.

Operation Warp Speed is the federal initiative, funded by more than $10 billion of taxpayer money, to fast-track development of coronavirus countermeasures.

“The now accelerated timeline underscores the need to address the issue of funding for state and territorial health agencies to make this all work,” Fraser said. “There are many other costs that have no clear way to be paid for at this point.”

Local officials still need to recruit thousands of people to staff vaccine clinics and enroll and train providers. They also have to ramp up information technology and data systems to track vaccine inventory and ordering to ensure people get the correct doses at the right times — most vaccines will require two shots — and to monitor for adverse events. They will need to develop locally tailored vaccination communications campaigns, too.

“States have received some funding, but it’s not nearly enough” to support the scale, scope and

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Analysis: What Do Waning COVID-19 Antibodies Tell Us About Immunity and Vaccines? | Top News

LONDON (Reuters) – Growing evidence that COVID-19 antibody levels can wane swiftly after someone is infected is not necessarily bad news for immunity, experts said on Thursday, and does not mean protection offered by coronavirus vaccines will be weak or short-lived.

Specialists in immunology and viruses warned against reading too much into studies of antibody levels in the blood of people previously infected with COVID-19, cautioning that antibody readings do not translate directly into levels of protective immunity.

“The concentration of antibodies in your blood does not equal immunity,” said Eleanor Riley, a professor of immunology and infectious disease at Britain’s University of Edinburgh.

She and other experts said reports earlier this week which suggested immunity to COVID-19 might decline in line with falling blood antibody levels failed to account for the many complexities in how the body builds immunity to infections.

“Immunity is not something we can just wrap up in measuring an antibody or T-cell response,” she told Reuters. “Immunity is about the system working together so that next time you come across the infection, you either won’t get it at all or won’t get seriously ill from it. That’s protective immunity.”

While antibodies induced by natural COVID-19 infection may start to decline in few months, as a study by researchers at Imperial College found on Tuesday, the many potential COVID-19 vaccines in development are designed to induce more durable immunity by invoking strong so-called immune memory.

IMMUNE MEMORY IS MORE IMPORTANT

“Antibody responses are usually short-lived because once they have done their job you don’t need them,” said Jonathan Stoye, head of virology at Britain’s Francis Crick Institute.

“But that doesn’t mean that immunity, either induced by infection or by vaccination, is necessarily short-lived: Memory cells can respond to and combat a new infection.”

Since SARS-CoV-2, the virus that causes COVID-19, is a new human virus, scientists don’t yet know what levels of immunity will turn out to be protective. But many of the vaccine makers are touting both the antibody and T-cell responses, which are increasingly seen as important to lasting immunity.

“The immune system is very complicated. We know antibodies are important, but they’re not the whole story,” said Lawrence Young, a professor of molecular oncology at Britain’s Warwick University. “The important thing here is immune memory.”

Key to the process of immunity are memory cells known as T- and B-lymphocytes. Having made antibodies to a certain virus in an initial infection, the body uses these cells to remember that pathogen, “so when you are next exposed to the virus, the antibody response kicks in much sooner”, Young said.

With vaccines, a key feature is that scientists developing them can select as targets the most important bits of the pathogen – in COVID-19’s case these include the so-called “spike protein” on the surface of SARS-CoV-2 virus – to get the strongest and most lasting memory responses from T and B lymphocytes.

Some vaccines also contain stimulators or boosters, known as adjuvants, which can supercharge the

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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another

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J&J, AstraZeneca resuming trials of vaccines [Video]

Two trials involving coronavirus vaccine candidates are resuming. AstraZeneca has restarted the U.S. trial of its experimental COVID-19 vaccine, and Johnson & Johnson is set to resume its trial on Monday or Tuesday.

AstraZeneca said Friday the U.S. Food and Drug Administration has deemed it safe to continue testing the vaccine. The company had to pause its U.S. trial last month after a report of a serious neurological illness in a participant in its trial in the UK.It is developing its vaccine with researchers at Oxford University.

Johnson & Johnson said Friday that the independent safety panel, the Data and Safety Monitoring Board, has recommended that it resume trial recruitment after finding no evidence that the vaccine caused a volunteer to fall ill. The company says it’s on track to produce trial data of the vaccines’ effectiveness by the end of this year or early 2021.

Both companies have contracts to supply vaccines to the U.S. and other governments if they are cleared by regulators.

Video Transcript

Two trials involving coronavirus vaccine candidates are resuming. AstraZeneca has restarted the US trial of its experimental COVID-19 vaccine, and Johnson & Johnson is set to resume its trial on Monday or Tuesday.

AstraZeneca said Friday, “The US Food and Drug Administration has deemed it safe to continue testing the vaccine.” The company had to pause its US trial last month after a report of a serious neurological illness in a participant in its trial in the UK. It is developing its vaccine with researchers at Oxford University.

Johnson & Johnson said Friday [? that, ?] “The independent safety panel, the Data and Safety Monitoring Board, has recommended that it resume trial recruitment after finding no evidence that the vaccine caused a volunteer to fall ill.” The company says it’s on track to produce trial data of the vaccine’s effectiveness by the end of this year or early 2021.

Both companies have contracts to supply vaccines to the US and other governments if they are cleared by regulators.

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Health officials ramp up flu shot efforts, including free vaccines at Audubon Zoo on Oct. 26 | The Latest | Gambit Weekly

Health officials at the Louisiana Department of Health and the City of New Orleans are asking Louisianans to roll up their shirt sleeves and get flu shots as they ramp up efforts to distribute these essential vaccines.

Amid the ongoing COVID-19 pandemic, for which there is still no vaccine or cure, health officials say it’s more important than ever to get the shot, especially because COVID-19 and the flu sometimes have similar symptoms and both can be fatal. They have for months warned of a “twin-demic” this fall and are concerned about overwhelmed hospitals, as the flu can also lead to lengthy stays and require medical care around the clock.

Dr. Gina Lagarde, the LDH’s regional medical director for the Northshore, said the health department will be conducting “mass vaccination exercises in each of the state’s regions” over the next several weeks, in partnerships with local pharmacies. The department will be making an extra effort to reach out to historically under-vaccinated populations, including low-income, rural and minority communities that frequently lack access to health care.

On Oct. 26, free vaccines will be available at the Audubon Zoo from 1 to 6 p.m., in partnership with New Orleans Health Department, New Orleans Office of Homeland Security and Emergency Preparedness and the Audubon Zoo. 

 “It is critical,” Lagarde told Gambit. “We worry about the surge to our emergency rooms. With the cold and flu season, we know the impact on our emergency rooms and in our hospitals. We need to get as many people as vaccinated as possible.”

The Centers for Disease Prevention and Control and the LDH have long recommended a yearly flu shot for everyone over 6 months of age and note that it’s especially crucial for people at higher risk of serious complications, including babies and young children, pregnant women, people with chronic health conditions and citizens aged 65 years and older.

Most seasonal flu activity occurs between October and May, peaking between December and February. The LDH notes that the flu shot will not prevent COVID-19, but it will reduce the burden of the flu illness, hospitalizations and deaths. Though the flu is less fatal than COVID-19, both are highly contagious illnesses that can impact long-term health and require lengthy recovery periods.

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RNA COVID Vaccines; Down Syndrome Guidelines: It’s TTHealthWatch!

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

This week’s topics include two RNA SARS-CoV2 vaccines, an inactivated vaccine, a look at who’s willing to be vaccinated, and guidelines for managing Down syndrome manifestations.

Program notes:

1:06 RNA vaccines

2:00 Similar immune responses young or old

3:00 Inactivated virus

3:10 Vaccine hesitancy

4:10 Vaccine attributes multiple

5:12 Suggests ways to address hesitancy

6:13 Rigorously tested even for an EUA

6:41 An inactivated viral vaccine

7:42 Inactivated vaccines must be made properly

8:44 Not a narrow vaccine

9:12 Guidelines for managing Down syndrome manifestations

10:13 Literature survey

11:12 Congenital heart disease common

12:45 End

Transcript:

Elizabeth Tracey: When a SARS-CoV-2 vaccine comes across the transom, will you take it?

Rick Lange: Report on a promising inactivated whole-virion COVID vaccine.

Elizabeth: What’s the best care for people with Down syndrome?

Rick: And the safety and immunogenicity of two RNA-based COVID vaccines.

Elizabeth: That’s what we’re talking about this week on TT HealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: And right now in the nation’s hotspot, I would say, relative to battling COVID-19. How’s it going?

Rick: You know, it’s really tough here. I think we have the highest number of cases per capita across the U.S. and increasing. It’s a really tough time in El Paso right now, so some of the stuff we’re talking about is very relevant.

Elizabeth: Yeah. Let’s turn, then, to… why don’t you talk about the first vaccine candidate that you’d like to illustrate?

Rick: Okay. This is a report from Pfizer and a company called BioNTech that is one of those vaccines that’s in phase III trials, so this is the initial report of their phase I and phase II trials. BioNTech and Pfizer launched a coordinated program to compare four RNA-based COVID-19 vaccine candidates. They did it in Germany initially and then brought it to the U.S.

This is a report on two of those RNA-based vaccines and how they decided for one over the other. I’m going to call them B1 and B2, because that’s what they call them. B1 is a RNA vaccine directed towards the receptor-binding domain. They took three of these domains and actually bound them together, which could be more antigenic, and the B2 was they took the whole spike protein.

They tested these in individuals 18 to 55 and those 65 to 85, and they did multiple different doses of these. What they discovered is

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AstraZeneca, J&J resuming US tests of COVID-19 vaccines

Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.

Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.

The two coronavirus vaccines are among several candidates in final-stage testing, the last step before seeking regulatory approval.

The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S.

Such temporary halts of drug and vaccine testing are relatively common: In research involving thousands of participants, some are likely to fall ill. Pausing a study allows researchers to investigate whether an illness is a side effect or a coincidence.

Testing of the AstraZeneca vaccine, developed with Oxford University, has already resumed in the United Kingdom, Brazil, South Africa and Japan.

“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, AstraZeneca’s CEO, said in a statement.

AstraZeneca’s study involves 30,000 people in the U.S., with some getting the vaccine and others a dummy shot.

Testing was stopped after one British participant developed severe neurological symptoms consistent with a rare inflammation of the spinal cord called transverse myelitis. AstraZeneca testing had also been paused earlier in the summer.

Johnson & Johnson said it’s preparing to resume recruitment soon for its U.S. vaccine study. In a statement, the company didn’t disclose the nature of the volunteer’s illness but said a thorough evaluation “found no evidence that the vaccine candidate caused the event.”

The company added that it’s in talks with other regulators around the world to resume testing in their countries.

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Follow Linda A. Johnson on Twitter: @LindaJ_onPharma

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The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Experts Tell F.D.A. It Should Gather More Safety Data on Covid-19 Vaccines

Vaccine experts peppered officials at the Food and Drug Administration with a range of questions on Thursday about its guidelines for approving a coronavirus vaccine, pushing the agency on whether it should wait longer to collect more safety data and whether an emergency approval could jeopardize the outcome of the broader clinical trials.

The stakes, the experts said, could not be higher. Even as a vaccine is seen as crucial to ending the pandemic, opinion polls have shown that Americans are increasingly skeptical about the products and worry that the vetting process is being rushed.

“In this particular case, public trust equals success,” said Sheldon Toubman, the consumer representative on the advisory group. “Lack of trust means no success.”

The meeting, which lasted all day and was broadcast on YouTube, also included a presentation by a nonprofit group that interviewed people about their views about a coronavirus vaccine. Several people of color expressed concern about whether the vaccine had been studied in people who are Black, Latino or Native American.

Others said their skepticism had historical roots dating to the Tuskegee Syphilis Study, in which government scientists lied to Black men and allowed them to go untreated for syphilis. “I firmly believe that this is another Tuskegee experiment,” one participant said.

The expert panel was not asked to evaluate a specific vaccine — none of the companies developing one so far have results from large clinical trials — but rather to weigh in on how the F.D.A. should vet the candidates. The agency has said that it will ask the panel for its opinion before approving any coronavirus vaccine for emergency use. The agency typically, but not always, follows the advice of its outside experts.

Four companies are conducting late-stage clinical trials in the United States, and some have estimated they will have preliminary data that may allow them to apply for emergency authorization in certain high-risk groups by the end of November. One of the companies, Moderna, said on Thursday that it had fully enrolled its trial of 30,000 participants, the first company to do so.

Several of the experts said that they believed the agency should ask the companies to wait for more safety data. They said the agency’s current guidelines, which require two months of safety data after a volunteer has received the last dose of a vaccine, were not good enough. Collecting longer-term data would allow them to evaluate potential risks, such as whether immunity to the virus wanes after a few months, or whether rare side effects emerge.

The experts were also asked to give their opinions about what should happen to the clinical trials if the F.D.A. were to approve a vaccine for emergency use based on promising early data. Pfizer has said that if a vaccine is approved for emergency use, the company will be ethically obligated to offer the vaccine to people in the trial who received a placebo instead of the actual vaccine. But this would “unblind” the trial by revealing

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