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Pfizer and Moderna pledge a massive vaccine surge



“Because of the dire need to vaccinate more people, we have ramped up production of doses,” John Young, Pfizer’s chief business officer, told the House Energy and Commerce oversight and investigations subcommittee in prepared testimony.

But achieving a surge on that scale remains daunting. Pfizer and Moderna, the companies with the only authorized vaccines so far, will need to increase their combined deliveries to date of 75 million doses to reach their promised target of 220 million shots by March 31.

That’s a goal of 28 million doses each week on average, far greater than their performance so far. The Biden administration said last week that doses allotted to states would grow from 11 million to 13.5 million per week, and it also directed 2 million doses to pharmacies, part of allocations that are expected to increase modestly again this week.

If the companies are able to meet their projections, it would signal the beginning of the end of a period of deep frustration and mark faster progress against a pandemic that has claimed 500,000 lives in the United States. The slower-than-anticipated vaccine rollout has hampered progress toward vaccinating the 70 or 80 percent of the U.S. population of 330 million people required to achieve herd immunity against the coronavirus.

Pfizer and Moderna, which both make mRNA vaccines, fell far short of the delivery schedules set by the Trump administration in December, when their vaccines received emergency authorization from the Food and Drug Administration. But both companies are expressing confidence in their latest promises after continuing to invest in manufacturing and steadily advancing production. Combined, the two companies have contracts to provide 600 million doses, which they say will be ready by the end of July.

Pfizer, which is partnered with Germany’s BioNTech in production of its vaccine, has laid out an aggressive timeline for boosting deliveries in coming weeks, according to Young’s advance testimony. The company has been pouring money into doubling batch sizes and adding manufacturing suites, as well as making its own supply of crucial raw materials called lipids and creating its own finish-fill capacity to put batches of vaccine into vials for shipment.

Pfizer reported last week during President Biden’s visit to its Kalamazoo, Mich., manufacturing plant that it had reduced manufacturing time from 110 days to about 60 days.

Pfizer also benefited from an FDA decision that recognized “overfill” in its vials as a sixth dose, creating a 20 percent increase in its deliveries.

Uneven weekly production is among the reasons the Biden administration has not issued new promises beyond its initial goal of delivering 100 million shots within the president’s first 100 days, despite drugmakers’ more ambitious promises, according to a senior administration official who, like other officials addressing production schedules, spoke on the condition of anonymity because of the matter’s sensitivity.

The administration is aiming to hold the companies to their commitments, the official said, while maintaining “collaborative enough relationships where they will share risks, as opposed to putting a gun to their head and saying, ‘You have to do X or Y and we don’t want to hear anything about it.’ ”

Two other Biden administration officials said it was unlikely that 220 million vaccine doses would be distributed by the end of March, even if a quantity approaching that total was allocated to states and other jurisdictions without being shipped by then. One official said just shy of 200 million doses was a more realistic estimate.

The potential for a supply pinch as the first quarter draws to a close late next month could represent a smaller-scale reprise of problems that bedeviled the Trump administration at the end of last year. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, estimated Dec. 20 at a meeting of a CDC advisory panel that there would be 40 million doses delivered in December, 60 million in January and 100 million in February — projections that proved much higher than reality.

Publicly posted CDC data indicates that about 75 million doses had been delivered as of Monday — about 10 million fewer doses than the companies said in their prepared testimony that they have provided.

Federal officials said delivered doses were split about evenly between the two companies. About 44 million people have received shots, with nearly 20 million of those people having received both required injections, for a total of about 64 million shots.

Pfizer’s promise is to provide 120 million doses by the end of March, while Moderna has said it will supply 100 million doses by then. To meet its target, Pfizer would have to release more than 2 million doses a day, or more than 14 million a week, for the next five weeks. The company currently is providing about 9 million doses a week, according to one of the federal officials involved in the vaccine effort, with the expectation that it can climb steadily to about 13 million doses per week by the beginning of April. Moderna is expected to level out at about 10 million per week, the official said.

Moderna said in its prepared testimony that it had produced 45 million doses as of this week, which leaves 55 million, or more than 10 million per week, to reach its goal of 100 million by March 31.

“As we work to meet these goals, we are continually learning and working closely with our partners and the federal government to identify ways to address bottlenecks and accelerate our production,” Moderna President Stephen Hoge said in prepared remarks.

The single-shot Johnson & Johnson vaccine, which is expected to be authorized for emergency use as soon as this weekend, also will provide a significant boost, though federal officials say only a few million doses will immediately be available.

After that slow start, the company will deliver 20 million doses by the end of March, Johnson & Johnson said in its prepared testimony. By the end of April, the company is projected to have delivered nearly 60 million doses to the United States, officials said — well on its way to meet its promise of supplying 100 million doses by the end of June.

“The production of our vaccine is a highly complex process that requires very particular capabilities and experiences,” Richard Nettles, vice president of U.S. medical affairs for Johnson & Johnson’s Janssen division, said in his prepared testimony. “As a result, there are significant challenges inherent in scaling manufacturing output and accelerating the timeline needed for a coronavirus vaccine.”

To prepare for an expected surge of vaccine, federal officials are organizing mass vaccination sites in stadiums and parks throughout the country. They are directing more vaccine supply directly to retail pharmacies. And they are telling states that, within a few months, supply of the shots could begin to outpace demand, requiring a redoubled effort to persuade reluctant people to be immunized.

Andy Slavitt, a White House senior adviser on the coronavirus response, said he spends as much time on demand-side models as on those addressing supply shortages. Behavioral factors influencing vaccine hesitancy, he said, present a “different but no less critical challenge than getting a factory to produce more supply.”

Prepared testimony for the House hearing provided a more detailed public look inside the production of vaccines by companies that are traditionally secretive about their production procedures and data. Lack of visibility into production schedules for Pfizer, in particular, has been a source of frustration for federal officials, although senior Biden administration officials maintain they have stronger communication lines into the manufacturing process than did the Trump administration. That includes in-person monitoring of manufacturing “as needed,” according to a senior Biden administration official who spoke on the condition of anonymity because of the sensitivity of the matter.

One of the central aims of Biden’s team was to provide states with better supply forecasting so they could prepare the needed workforce, determine eligibility groups and set public expectations. In the first several weeks of the rollout, state officials complained of being caught off guard by last-minute changes to their allocations. Less than a week after Biden took office, the administration increased weekly allocations by 16 percent and pledged to provide estimates of anticipated supply three weeks in advance.

That has proved more challenging than the president’s team expected, in large part because production increases have been uneven. Biden’s advisers have been able to notify states of increased supply each week — typically on calls with governors led by Jeff Zients, the White House’s coronavirus coordinator — but the three-week estimates have become less reliable.

Much of the difficulty in supply forecasting owes to fill-finish bottlenecks, which federal officials describe as the most important obstacle to increasing manufacturing.

Last week, Moderna disclosed what it described as “short-term delays in the final stages of production and release of filled vials” encountered by its production partner, New Jersey-based Catalent. The same company is performing fill-finish functions for Johnson & Johnson. Moderna stressed that it would be able to meet monthly targets, and federal officials said there was no decrease in supply available to states. Moderna has asked the FDA to permit it to add up to five more doses in each of its vials, which currently hold 10 doses, which would improve finish-fill capacity by 50 percent.

Officials in states throughout the country maintain they have the ability to administer as much as five times the amount of vaccine they are receiving. The promise of a flood of shots, they say, could help them end the pandemic.

“We have the capacity and infrastructure in place to drastically ramp up how fast we can get shots in arms in Connecticut if we have the supply to make it happen,” said Connecticut Gov. Ned Lamont (D). “The Biden administration has provided predictability and increased numbers of doses, supporting our efforts at the state level, and so long as that continues, the light at the end of the tunnel gets closer and closer.”



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The C.D.C. advisory panel has endorsed the Moderna vaccine.


An independent panel of experts advising the Centers for Disease Control and Prevention voted on Saturday to endorse a second coronavirus vaccine for use in adults 18 and older.

The committee’s recommendation, by a vote of 11 in favor and none against (with three recusals due to conflicts of interest), followed Friday’s announcement that the vaccine, made by Moderna, had been granted an emergency authorization by the Food and Drug Administration.

The advisory committee’s endorsement now awaits final approval from Dr. Robert R. Redfield, director of the C.D.C., which is expected shortly.

The committee’s vote signals to hospitals and doctors that they may proceed to inoculate patients with the Moderna vaccine. Some 5.9 million doses are scheduled to ship on Sunday, and the first vaccinations are expected to begin on Monday.

Unlike the Pfizer-BioNTech vaccine, which was authorized for use in people 16 and older, Moderna’s inoculations are intended for adults only. (Moderna did not begin its pediatric studies until Dec. 9 and did not expect to have a full set of data until sometime next year.)

In adults, Moderna’s vaccine was more than 94 percent effective at preventing symptomatic cases of Covid-19. It’s still unclear how well the two vaccines fare at curbing coronavirus transmission.

Much of the advisory committee’s deliberations centered on the severe allergic reactions reported after injections of the Pfizer-BioNTech vaccine, which contains ingredients similar to those in Moderna’s recipe.

Six cases of anaphylaxis have now been documented in the United States, as well as two in Britain. In addition, milder allergic reactions have been reported. Experts have said these cases shouldn’t deter a vast majority of people from getting the vaccine. More than 272,000 doses of Pfizer’s vaccine have already been doled out nationwide.

Half of the people who received Moderna’s vaccine in clinical trials also reported some uncomfortable symptoms, including fatigue, headaches and soreness, after their second shot, given about four weeks after the first. Some volunteers also developed fevers or rashes around injection sites.

Incidents like these appear to be much more common with Moderna’s vaccine than Pfizer’s, which contains a smaller dose of active ingredients. But most of the side effects disappeared within a day or so of the shot.

Neither Moderna nor Pfizer has yet collected data in people who are pregnant or breastfeeding. But none of the 13 volunteers who became pregnant while participating in Moderna’s clinical trials, six of whom received the vaccine, reported harmful effects.

Dr. Jacqueline Miller, Moderna’s senior vice president, also drew attention to the representation of people of varying races and ethnicities in Moderna’s trials — a nod to the disproportionate effect of the pandemic on communities of color.

In discussions this week, experts repeatedly noted the importance of partnering with representatives from communities of color to reaffirm vaccine safety and efficacy for people who might be skeptical of the shots.

On Sunday, C.D.C. officials will deliver more guidance about allocating the newly cleared vaccines.



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FDA Authorizes use of Moderna COVID-19 Vaccine


Dec. 18, 2020 — As expected, the FDA granted Moderna an emergency use authorization for its COVID-19 vaccine, doubling the number of vaccine doses expected to be available in the coming days for distribution nationwide.

There is one final step — the CDC’s Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer vaccine received its EUA on Dec. 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.



Scaling up distribution of the two vaccine products will come next.

“Even under less emergent conditions, sometimes making sure people who need to get a vaccine can be hard. I hope the media attention around this will make more people aware that there are vaccines that might help them,”

said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The emergency authorization for the Moderna vaccine follows a review by the independent committee on Thursday, which voted to 20 to 1 with one abstention to recommend the authorization..

Emergency approval of a second COVID-19 vaccine “is great – we need all the tools we can to fight this pandemic. The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of Medicine at UChicago Medicine, told Medscape.

“It’s incumbent upon all us health care professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz said. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase III clinical trials.

“I know the critical role physicians play as vaccine influencers,” American Medical Association President Susan Bailey, MD, said during a Dec. 14 webinar for journalists. “We have to continue to do what physicians have always done. Review the evidence and trust the science. Lives are at stake.”


Ramping Up Health Care Provider Immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for health care workers and staff – and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, told Medscape.

“We had been hoping for a vaccine with a 70% or 80% efficacy to see, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both the Pfizer and Moderna messenger RNA vaccines “did exceed expectations for sure – this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology and a researcher in the Vaccine and Treatment Evaluation Unit at Baylor College of Medicine in Houston.


Unanswered Questions Remain

Schrantz likewise said the high efficacy rate was a positive. “That being said, what we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge is another question. Answers could come over time from the ongoing phase III trials, as well as from monitoring vaccine recipients.


Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on Dec. 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”


Advantages Beyond the Numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more product is the potential to offer an option when a specific vaccine is not recommended for specific individuals. “We could offer someone a different vaccine … similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle – the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and member of the FDA advisory committee, said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product dose not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”


Future Outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccine from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”




WebMD Health News


© 2020 WebMD, LLC. All rights reserved.





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Moderna, Pfizer, AstraZeneca covid vaccines: What you need to know


After more than 300,000 covid-19 deaths and 16 million infections in the United States, the first coronavirus vaccine was administered to U.S. health-care workers on Dec. 14. Public health officials are hoping that at least 70 percent of the population will get one of the vaccines being rolled out so that the nation can achieve herd immunity and stop the virus’s spread. Here are answers to some frequent questions.

How does the Pfizer-BioNTech vaccine work?

The first vaccine authorized in the United States was developed by pharmaceutical giant Pfizer and the German firm BioNTech. It consists of two shots, given three weeks apart.

The Pfizer vaccine is also the first vaccine 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. It uses a synthesized scrap of genetic information that is wrapped in a protective fat layer to keep it from disintegrating. When it goes into cells in the muscle of the upper arm, it contains molecular instructions that tell your cells to create a protein that triggers an immune response to the spike protein on the surface of the coronavirus. This means your immune system will be prepared to eliminate the pathogen if it tries to invade.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions

for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic

T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions

for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic

T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

RNA vaccines contain a strip of genetic material within a lipid bubble.

Inside the cell, ribosomes read the mRNA instructions for the spike protein.

The cell then begins to generate copies of the spike protein.

Antigen-presenting cells (APCs) consume the viral proteins and pass viral peptides to T-helper cells.

The immune system, presented with the peptide, learns to recognize the virus and releases cytotoxic T cells and B cells.

Cytotoxic T cells detect and eliminate virus-infected cells.

Antibodies from B-cells block the virus from infecting healthy cells.

Is it safe?

The FDA authorized the vaccine for people age 16 and over after reviewing data from 44,000 participants in a randomized clinical trial. A 53-page analysis by the agency found that some people who received injections had unpleasant but tolerable side effects, including fatigue, headaches, muscle pain, joint pain, chills and fever. Reviewers said the two months of follow-up on 38,000 of those participants provide evidence of “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].”

Will the vaccine protect me from getting covid-19?

The two-shot Pfizer-BioNTech vaccine has been shown to be 95 percent effective in randomized trials. The FDA’s independent review found that of more than 20,000 people who received both vaccine doses, only eight contracted covid-19, and just one person fell seriously ill. By contrast, 162 people in the placebo group contracted covid-19, and nine of those people developed serious illness. There was even some evidence the first shot of the vaccine protected against illness, but the FDA said there was insufficient data to draw firm conclusions. It is also not yet known whether the vaccine prevents infection, as well as illness — a question with big implications for viral spread.

Pfizer enrolled approximately 44,000 people in its late-stage clinical study in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Researchers divided the participants into two groups:

One group received two doses of the vaccine.

Another group was given two doses of a placebo.

One dot

represents

eight

people

8 sick with covid-19 from the vaccine group,

1 severely ill

162 sick with covid-19 from the placebo group,

9 severely ill

Pfizer enrolled approximately 44,000 people in its late-stage clinical study in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Researchers divided the participants into two groups:

One group received two doses of the vaccine.

Another group was given two doses of a placebo.

One dot

represents

eight

people

To eliminate any unintentional bias toward the results, neither group knew whether they received the vaccine or the placebo.

 

Participants were exposed to the coronavirus as they went about their normal routines.

8 sick with covid-19 from the vaccine group, 1 severely ill

162 sick with covid-19 from the placebo group, 9 severely ill

Pfizer enrolled approximately 44,000 people in its late-stage clinical study in the United States, Germany, Turkey, South Africa, Brazil and Argentina. Researchers divided the participants into two groups:

One group received two doses of the vaccine.

Another group was given two doses of a placebo.

One dot

represents

eight people

To eliminate any unintentional bias toward the results, neither group knew whether they received the vaccine or the placebo.

 

Participants were exposed to the coronavirus as they went about their normal routines.

8 sick with covid-19 from the vaccine group, 1 severely ill

162 sick with covid-19 from the placebo group, 9 severely ill

Should I still get vaccinated if…

I already had the coronavirus?

The Centers for Disease Control and Prevention says vaccination should be offered to people regardless of whether they had a prior infection. We are still learning how long immunity to the coronavirus lasts, after an infection or a vaccination. Typically, an infection causes better immunity than a vaccine, but not always — the vaccines for tetanus and human papillomavirus, for example, offer better protection than recovering from a natural infection.

What if I have covid-19 now?

It’s best to wait to be inoculated until you’ve recovered from your illness and have met all the criteria to end self-isolation to avoid spreading the infection to others. There is no recommended minimum interval to get vaccinated after you’ve recovered.

I’m pregnant, plan to get pregnant soon or I’m breastfeeding?

Pregnant or breastfeeding women who are part of a group recommended to get the shot — for instance, health-care workers — might want to consider talking with their medical providers beforehand. Pregnant women have been excluded from coronavirus vaccine trials, so there is no data on the safety of the vaccines for them, or its effects on the breastfed infant.

The American College of Obstetricians and Gynecologists says a conversation with a woman’s clinician may be helpful, but should not be required. Pregnant women who get infected with the coronavirus are at greater risk of death and severe illness than women who are not pregnant, even as the overall risk remains small.

The Pfizer vaccine does not contain live virus, or any enhancers to boost an immune response, and is not thought to be a risk to the breastfeeding infant. It does not alter human DNA in the people who get it and cannot cause any genetic changes. Also, this type of vaccine breaks down quickly and doesn’t enter the nucleus of the cell.

Pfizer said it is planning to report to the FDA by the end of the year on a developmental and reproductive toxicity study in animals that could help clarify any risks.

I have allergies. Can I get the new vaccine?

People who have mild allergies to food, pets, environment or latex can get the Pfizer-BioNTech vaccine.

Concern about allergies relate to reports from the United Kingdom of severe allergic reaction in two British health-care workers, both of whom were treated and recovered. Researchers do not know what substance in the vaccine formula triggered the severe allergic response. The CDC says people with a history of severe allergic reaction to any component of the vaccine should not get vaccinated.

If you have a history of severe allergic reaction to another vaccine or injectable therapy, however, that should not necessarily preclude you from getting the shots. But the CDC advises that you consult your doctor beforehand.

What about people with HIV infections or have other immunocompromising conditions, or who take immunosuppressive medications?

The vaccine hasn’t been studied in immunocompromised people, and they are not anticipated to be at increased risk of adverse reactions. However, they should talk to their providers beforehand because their immune systems may not respond optimally.

When will I be able to get vaccinated?

That depends on your job, your age and your health. For the most up-to-date information see The Post’s vaccine distribution tracker.

The vaccines began to be distributed as soon as mid-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 CDC. Government officials said that if both the Pfizer and Moderna vaccines are authorized, they anticipate having enough doses for 20 million people by year’s end.

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 vaccine from Pfizer and BioNTech must be kept at an ultracold, minus-70 degrees Celsius, a requirement that will add a wrinkle to an unprecedented vaccination campaign. The company has created its own GPS-tracked coolers filled with dry ice to distribute it.

How Pfizer will ship its vaccine at ultra-low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials. Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus- 70 degrees Celsius.

How Pfizer will ship its vaccine at ultra-low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials.

Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus-70 degrees Celsius.

How Pfizer will

ship its vaccine

at ultra-low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials. Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus-70 degrees Celsius.

How Pfizer will ship

its vaccine at ultra-

low temperatures

The frozen vaccine is packaged into 2-milliliter glass vials — each holding five doses.

One tray holds 195 vials. Up to five trays fit into a box.

The vaccine cartons are surrounded by 50 pounds of dry-ice pellets.

A GPS temperature monitor is placed in each shipment. The vaccine must be kept below minus-70 degrees Celsius.

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.

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 rural areas that don’t have specialized freezers.

How were the vaccines made so fast?

Historically, vaccines have taken years to develop. Before these, the mumps vaccine — which took four years to develop — was the fastest to be approved for use in humans. Developing messenger RNA vaccines like the Pfizer and Moderna candidates has been fast because scientists were able to start their work before there was a known case of the novel coronavirus in this country, using the viral genome shared online as a template. Making messenger RNA vaccines does not require time-consuming steps, such as growing ingredients in chicken eggs.

How much will the vaccines cost?

The federal government has pre-purchased hundreds of millions of vaccine doses with taxpayer money, and vowed to make them available free.

Will I still need to socially distance?

Yes. Even after a vaccine is approved, experts say people will need to wear masks and socially distance — in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading. Experts say the return to normalcy could take many months or longer.

Will I have a choice on which vaccine to take assuming more than one is approved?

Supply will be far short of demand initially, so you are unlikely to be offered options in the near term. Also, the vaccines have different storage and handling requirements making it likely that each administration site will only have one vaccine on hand, at least to start with.

But Kelly Moore of the Immunization Action Coalition believes that once there are plenty of products available, that may change. Moore hopes supply may meet demand by the second half of next year, opening the potential for people to have options, particularly if one vaccine is preferable for certain age groups, for example.

Frances Stead Sellers, Lena H. Sun, Christopher Rowland, Chris Alcantara and Sarah Kaplan contributed to this report.

This story was first published November 17.



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Moderna to ask the FDA to greenlight its coronavirus vaccine



The application arrives as public health experts gird for a blitz of coronavirus cases seeded by holiday travels and gatherings — a surge coming so soon that no vaccine can blunt it. But Moderna’s filing marks the fourth Monday in a row with good news about the vaccine effort and means the United States could have enough vaccine to treat 20 million people by year’s end, between doses of Moderna’s vaccine and those of another candidate that is about a week ahead from Pfizer and German firm BioNTech. The Food and Drug Administration could authorize the vaccines for emergency use by mid- to late December.

“You don’t want to get ahead of yourself and claim any victories, but this has the makings of a very, very important positive impact on ending this outbreak,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. “A vaccine that is highly efficacious, if taken by a very, very high percentage of people, could potentially crush this outbreak — similar to what was done with outbreaks of measles and polio and smallpox and other diseases.”

The coming weeks, while likely to strain an already overburdened health-care system, will also bring a whirlwind of regulatory decisions on the vaccines that could signal an eventual end to the pandemic.

“The data are very, very promising, but I would like to see more data than is currently in the press release,” said Walter Orenstein, associate director of the Emory University Vaccine Center, who is also a member of Moderna’s scientific advisory board and a trial participant.

Orenstein added that even those who are first in line to receive two doses of the vaccine will likely be encouraged to continue to take precautions, such as wearing masks, if virus is circulating at high levels in the community.

The vaccines from Moderna and Pfizer and BioNTech are a major proof of concept for a flexible and fast medical technology, years in the making, that utilizes a snippet of genetic material called messenger RNA that teaches cells to build the spiky protein found on the surface of the coronavirus. The immune system learns to recognize and block the real virus.

The data have yet to be published, but they will be scrutinized closely by regulators and an outside committee of experts in coming weeks. On Tuesday, an advisory committee to the Centers for Disease Control and Prevention will make recommendations on which groups of people should receive the first doses, which will be in short supply for months. Pfizer and BioNTech’s vaccine will be debated by a group of expert advisers to the FDA on Dec. 10, and Moderna’s vaccine is expected to be considered a week later, on Dec. 17.

The United States government, through Operation Warp Speed, has preordered 100 million doses from both Moderna and Pfizer, and helped underwrite the research and development of Moderna’s vaccine to the tune of $955 million. Moderna also signed a contract to provide 100 million doses to the U.S. at $1.5 billion. Pfizer will provide 100 million doses at a cost of $1.95 billion. In addition, the government has an option to buy hundreds of millions more doses.

“Pfizer and Moderna’s incredibly promising and impressive efficacy data further demonstrate that President Trump’s Operation Warp Speed is rapidly advancing on a trajectory of success to save millions of American lives — five times faster than any other vaccine in history,” White House spokesman Michael Bars said in an email.

Both companies have said they would be ready to distribute a vaccine almost immediately after receiving a green light from the FDA. Results reported last week from a third coronavirus vaccine candidate, from AstraZeneca and the University of Oxford, were positive but confusing, and it is unclear yet whether that vaccine can move forward in the United States without more data.

In Moderna’s trial, volunteers were randomly assigned to two groups. One received two doses of the real vaccine and the other received doses containing salt water. Trial investigators then waited as people were exposed to the virus in their daily lives, to see if more cases occurred in the placebo group.

There were 196 cases of covid-19 in the study, 11 of which occurred in the vaccine group — a decisive signal that the vaccine protected people from illness. The 30 severe cases of covid-19 in the trial, including one death, all occurred in the group that got salt water shots.

The data will likely leave some questions unanswered. No one knows yet how long immune protection will last, and it is unclear whether the vaccine will decrease transmission in addition to preventing illness. One worst-case scenario that has been debated by scientists is a vaccine that prevents symptoms and disease but doesn’t decrease the spread of the virus by asymptomatic people.

The next challenges will be distributing vaccines and communicating the logic behind prioritizing certain groups for the limited initial supply of vaccine. The Advisory Committee on Immunization Practices will take up this question Tuesday, and is expected to include health care workers in the first phase, a strategy intended to ensure the first doses have an important societal impact.

“There’s a reason prioritization is set up as it is, and prioritizing health care workers first is also to keep our health care system functioning and to protect them,” said Natalie Dean, a biostatistician at the University of Florida. “Absenteeism is a problem.”

Health systems are already beginning to plan the rollout of potential vaccines to their front-line staff. Dean said her husband, a physician, recently received an email to register for a vaccine when one becomes available.

In its release Monday, Moderna reported that the vaccine performance was consistent across all ages, races, ethnicities and genders. There were 33 cases of covid-19 in people over 65; 29 cases in people who identified as Hispanic; 6 cases in Black people; 4 cases among Asian Americans; and 3 in multiracial people.

Most reactions to the vaccine were mild or moderate, according to a previous news release from the company. The adverse events rated as “severe” in the trial were soreness at the injection site, tiredness, muscle aches, headache and pain.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Stéphane Bancel, Moderna’s chief executive, said in a statement.

Moderna will also file Monday for a green light from the European Medicines Agency and has an open application with regulators in the United Kingdom, Switzerland, Canada, Israel and Singapore.

The vaccine can be stored frozen at minus-20 degrees Celsius and lasts at refrigerator temperatures for up to a month, which would likely make it easier to deploy than the candidate from Pfizer and BioNTech, which requires ultracold storage conditions not typically found at pharmacies and doctors’ offices.



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Moderna Vaccine, E.U., Joe Biden: Your Tuesday Briefing


As the coronavirus has surged again in recent weeks, much of the U.S. has chosen to keep restaurants open and schools closed. Much of Europe has done the opposite.

The European approach seems to be working better: While both Europe and the U.S. have suffered surges in cases, over the past two weeks France, Germany, Spain and Britain have managed to reduce their growth rates.

What is Europe doing differently? It is cracking down on the kind of indoor gatherings that most commonly spread the virus. England closed pubs, restaurants, gyms and more on Nov. 5 and announced they would remain closed until at least Dec. 2. France, Germany’s regional governments and the Catalonia region of Spain have also shut restaurants, among other businesses.

Many Americans have resisted accepting that reality. Across much of the country, restaurants remain open for indoor dining. Last week, New York State announced a new policy that public health experts consider to be a bizarre middle ground: Businesses with a liquor license can stay open until 10 p.m.

The one indoor activity that appears to present less risk is school, especially elementary school. Why? Young children seem to spread the virus less often than adults do.

Closing schools and switching entirely to remote learning, on the other hand, has big social costs. Children are learning less, and many parents, mostly mothers, have dropped out of the labor force. The U.S. is suffering from both of these problems and from a raging pandemic.


That’s it for this briefing. See you tomorrow.

— Natasha


Thank you
Theodore Kim and Jahaan Singh provided the break from the news. You can reach the team at briefing@nytimes.com.

P.S.
• We’re listening to “The Daily.” Our latest episode is about divisions among American Democrats.
• Here’s our Mini Crossword, and a clue: It’s “mightier than the sword” (three letters). You can find all our puzzles here.
• The word “kaitiakitanga” — a Māori word describing guardianship of the environment — first appeared in The Times on Monday, according to the Twitter account @NYT_first_said.
• Our Washington bureau chief Elisabeth Bumiller recently spoke with Nieman Reports about political reporting in a post-Trump era.





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Coronavirus vaccine is ready for first tests, says Biotech company Moderna



Initial trials of the potential vaccine could begin in April, but the process of testing and approvals would last at least a year.

Moderna (MRNA) said in a statement Monday that the first batch of its novel coronavirus vaccine, called mRNA-1273, has been sent to the National Institute of Allergy and Infectious Diseases (NIAID).

Shares in the company, which is located near Boston, were trading 15% higher in New York on Tuesday.

Moderna said the first vials of the experimental vaccine would be used in a planned Phase 1 study in the United States, which typically involves testing a vaccine on a small number of healthy humans.

NIAID Director Anthony Fauci said that a clinical trial could start by the end of April, the “first step” in potentially making a vaccine available for use.

The Wall Street Journal, which was first to report the development, said that two doses of the vaccine would be tested on volunteers to see if it produces an immune response that protects against the virus. Fauci told CNN that 45 people would participate in the trial.

Even if the clinical trial is successful, further testing and regulatory approvals would be needed before the vaccine could be deployed widely.

Health officials and pharmaceutical companies around the world are working at a breakneck pace to identify treatments or a vaccine to help fight the coronavirus, which has infected more than 80,000 people around the world.

Fauci previously told CNN that researchers could expedite the approval process for a vaccine following a successful Phase 1 trial in an attempt to halt the spread of the virus.

But even when proceeding at an “emergency speed,” a vaccine would not be available for use for at least a year or 18 months, he said Tuesday.

Moderna is not the only drug company hoping to find an immunization for the virus.

Pharma giants Johnson & Johnson (JNJ) and GlaxoSmithKline (GLAXF) are working on vaccines, as are government scientists including some at NIAID.
Shares in Gilead (GILD) gained nearly 5% on Monday after the World Health Organization said that one of its drugs, remdesivir, is showing signs of helping to treat the coronavirus.

While the experimental vaccine developed by Moderna remains unproven, the speed at which it was created represents a breakthrough.

According to Moderna, the vaccine was developed within 42 days of the company obtaining genetic information on the coronavirus.

By comparison, it took researchers about 20 months to start human tests of the vaccine for SARS, an older coronavirus, according to a journal paper written by Fauci.

mRNA vaccines

Moderna has yet to produce a proven vaccine with its mRNA technology platform, which aims to make drugs that direct cells in the body to make proteins to prevent or fight disease. It makes use of messenger ribonucleic acid, a molecule vital to the proper functioning of the body’s cells.

The technology has had positive results from Phase 1 tests across six different vaccines, one of which is currently in a Phase 2 trial, according to a company spokesperson.

The mRNA approach can produce vaccines faster and for less money than traditional methods, according to UK health policy think tank PHG Foundation.

— Paul R. La Monica contributed reporting.



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