Pfizer, Trump Administration Reach Deal for More Doses: Live Updates

The message of the moment. Photo: Angela Weiss/AFP via Getty Images

The largest mass vaccination campaign in U.S. history is underway now that two COVID-19 vaccines have been authorized for emergency use by the Food and Drug Administration. Inoculations for millions of health-care workers, long-term care facility residents, and other high-priority Americans (like President-elect Biden) are underway, using the Pfizer/BioNTech vaccine, which the FDA authorized for emergency use on December 11, and the second vaccine, made by Moderna, authorized on December 18.

Below are the latest updates, in reverse chronological order, on the U.S. vaccine rollout.

Pfizer, Trump Administration Reach Deal for 100 Million More Doses

After weeks of wrangling, Pfizer and the outgoing Trump administration have agreed that the pharmaceutical giant will provide 100 million more vaccine doses — enough for 50 million people — to the U.S. by the end of July. The deal significantly ups the portion of Americans who can be inoculated with vaccines that have already been proven effective.

Pfizer had already been under contract to provide 100 million doses, and hundreds of thousands of them have been administered across the country to frontline health-care workers, long-term care residents, and much of America’s political leadership. The U.S. has also acquired 200 million doses of Moderna’s two-shot vaccine candidate, which has shown to be highly effective, like Pfizer’s, and which received FDA approval last week.

As the New York Times reported earlier this month, the Trump administration could have ordered the additional doses it has now acquired months ago — Pfizer urged officials to do so — but strangely opted not to.

Warp Speed chief takes responsibility for last week’s vaccine shipment screw-up

During a press conference on Saturday, General Gustave Perna accepted blame for the federal government’s confusing failure to supply as many doses of Pfizer’s COVID-19 vaccine last week as it had told states they would receive. Reports the Washington Post:

[Perna said that] he was responsible for the “miscommunication” with states causing them to receive vastly fewer doses of the Pfizer-BioNTech vaccine in the second wave of shipments next week than they had been anticipating. The problem stemmed from mistaken forecasts he initially gave state officials, which did not account for steps involved in actually clearing available vaccine for release, he said. “There is a delay between what is available and what is releasable,” he said, “because we’re talking about hundreds and thousands and millions of doses that we want to make sure are right.”

And as Stat News points out, “The chaos over allotments followed labeling confusion that caused hospital pharmacists at several health systems to throw away one in every six doses of the first vaccines distributed.”

The Trump administration’s decision to hold back on shipping the second round of Pfizer doses also appears to be causing problems, the Post adds:

An added layer of complexity, Perna noted, was the need to have certainty about the availability of a second dose for each initial shot dispatched by the federal government. The Trump administration has opted to hold back booster shots to be delivered 21 days later in the case of the Pfizer-BioNTech vaccine, rather than sending out all doses for states and other jurisdictions to divide into first and second shots. The decision has baffled people close to Pfizer and surprised some state officials, who said it made their planning more difficult.

The side effects, so far

Stat News’ Helen Branswell summarizes the known side effects of both the Moderna and Pfizer vaccines:

The most common side effects are injection site pain, fatigue, headache, muscle pain, and joint pain. Some people in the clinical trials have reported fever. Side effects are more common after the second dose; younger adults, who have more robust immune systems, reported more side effects than older adults.

To be clear: These side effects are a sign of an immune system kicking into gear. They do not signal that the vaccine is unsafe. To date there are no serious, long-term side effects associated with receipt of these vaccines, which will be closely monitored as their use expands.

There have been a handful of reports of people having allergic reactions to the Pfizer vaccine since its rollout began. Those reactions — anaphylaxis or a less severe allergic reaction — were not seen in the clinical trials. It remains to be seen if similar events will be seen with the Moderna vaccine.

As expected, CDC panel recommends Moderna vaccine

The CDC Advisory Committee on Immunization Practices voted unanimously to recommend Moderna’s vaccine for adults 18 and older on Saturday. The panel is also looking into the handful of cases of severe allergic reactions to the Pfizer vaccine that were reported last week, as Medscape explains:

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria. …

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Moderna vaccine distribution process gets underway amid record surge of COVID-19 cases

Per CNN, it was another historically bad week when it came to the ongoing surge of COVID-19 cases nationwide:

Over the last week, the US averaged more than 219,000 new Covid-19 infections a day, according to a CNN analysis of data from Johns Hopkins University. There were more than 249,000 infections reported on Friday alone — another record. …

More than 18,000 Americans died of Covid-19 in the past week, adding to the more than 316,000 Americans that have died during the pandemic. The University of Washington’s Institute for Health Metrics and Evaluation projects that more than 237,000 Americans will die of Covid-19 in the next three months.

Meanwhile, shipments of Moderna’s vaccine are being prepped to go out on Sunday:

Distribution of the Moderna vaccine has “already begun,” said Army Gen. Gustave Perna, chief operating officer of Operation Warp Speed, the federal government’s vaccine initiative. “Boxes are being packed and loaded today,” he said in a news conference Saturday. “Trucks will begin rolling out tomorrow, from FedEx and UPS, delivering vaccines and kits to the American people across the United States.” …

More than 6 million doses of Moderna’s vaccine will be shipped to more than 3,200 sites where they will be administered – far more than the 636 sites that Pfizer’s vaccines were shipped to.

Now there are two: FDA authorizes Moderna vaccine for emergency use

As expected, on Friday night the U.S. Food and Drug Administration authorized emergency use of Moderna’s COVID-19 vaccine for adults 18 and older — making it the second coronavirus vaccine to become available in the U.S., one week after the first. Some 5.9 million doses of the two-shot Moderna vaccine will be distributed to states starting this weekend, and the doses should be easier to handle since the Moderna vaccine does not need to be shipped and stored at the same ultracold temperatures as the Pfizer vaccine. The Moderna vaccine, which like the Pfizer vaccine uses cutting edge mNRA technology, was found to be safe and 94-95 percent effective at protecting against COVID-19 in clinical trials.

Some 6.4 million doses of the two-shot Pfizer vaccine have been made available in the U.S. since it was authorized last weekend. The federal government will handle delivering the Moderna vaccine to states and territories, and because it is being shipped in smaller batches and requires less-extreme cold storage, it will be possible to distribute it to more remote destinations.

As with the Pfizer vaccine, it will be up to state and local authorities to determine who first receives the Moderna vaccine, and they will likely continue to follow CDC guidelines to give priority access to health care workers and residents of long-term care facilities.

Independent panel recommends FDA approve Moderna vaccine for emergency use

On December 17, a panel of independent experts voted overwhelmingly in favor of the Food and Drug Administration granting emergency use authorization to the Moderna vaccine candidate. With this counsel’s approval, the FDA is now expected to give the green light on Friday for the federal government to distribute a second COVID vaccine candidate, allowing 5.9 million more doses to be shipped across the country as early as Saturday.

States are already reporting delays and cutbacks in vaccine distribution

An analysis by Talking Points Memo reveals that a dozen states have either experienced delays or cuts to the initial number of Pfizer vaccine doses they were scheduled to receive from the federal government. Iowa and Missouri could see doses reduced by as much as 30 percent, while Kansas will receive 37 percent less. Illinois Governor J.B. Pritzker has said that Illinois may receive just half the amount the state was supposed to get in December. MarylandFlorida, Nebraska, and Oregon are also facing delays. These early problems are not strong signs that the nation will achieve its stated goal of beginning public vaccinations early this spring.

Biden will reportedly receive the vaccine next week

On December 16, the Associated Press reported that the president-elect will get his first dose of the vaccine as an early Christmas present during the holiday week — a crucial step in the 78-year-old’s coming battle to roll-out the vaccine and stop the spread of the virus in the interim.

Pharmacists may have figured out how to increase vaccine supply by 40 percent

Politico reports that pharmacists have contacted the Food and Drug Administration, informing government officials that vaccine vials already distributed have excess amounts of the vaccine in them — enough that there may be 40 percent more supply of the Pfizer vaccine than previously thought:

The Pfizer vials are supposed to hold five doses, but pharmacists have found they have enough for a sixth or even a seventh dose. Putting those into use could significantly increase the United States’ scarce early supply of the shot, reducing the likelihood of a “vaccine cliff” this spring as demand outpaces supply.

Manufacturers typically overfill vaccine vials to safeguard against spills and other waste, said Erin Fox, a pharmacy expert at University of Utah who monitors drug shortages. “It’s pretty unusual to have a full extra dose or more though — but it does seem to be there!” she said in an email.

Alaska health-care worker has serious allergic reaction to vaccine

A health care worker who received Pfizer’s coronavirus vaccine on Tuesday had a serious allergic reaction. They were still hospitalized as of Wednesday morning. The New York Times reports:

Government officials were scrambling on Wednesday to learn more about the case. The worker had no history of drug allergies but it was unclear whether he or she suffered from other types of allergies, according to one person familiar with the case.

With millions of Americans expected to be vaccinated by the end of the year, the incident is likely to prompt federal officials to be even more watchful for any sign of serious side effects. The Alaska recipient’s reaction was believed to be similar to the anaphylactic reactions two health workers in Britain experienced after receiving the Pfizer-BioNTech vaccine last week. Both of them recovered.

Pfizer’s trial in the United States involving more than 40,000 people did not find any serious adverse events caused by the vaccine, although many participants did experience aches, fevers and other side effects. Severe allergic reactions to vaccines are typically linked to the vaccine because of their timing.

State Department to receive vaccines as Pompeo quarantines after COVID exposure

The State Department is set to receive a “very limited number” of COVID vaccines this week, per CNN:

The State Department will be receiving a “very limited number of vaccines” protecting against the coronavirus this week and plans to distribute them to prioritized individuals – a group that includes front-line medical personnel and American personnel in Kabul, Baghdad and Mogadishu, the department revealed in a memo Tuesday from a top department official.

… In addition to front-line medical personnel and American personnel in Kabul, Baghdad and Mogadishu, Bulatao said, the department will initially “prioritize vaccination” of personnel supporting its 24/7 watch centers, critical operations, maintenance, custodial staff and mission-critical diplomatic security personnel in the national capital region.

It may not be soon enough for Mike Pompeo. The State Department announced Wednesday that he will quarantine following exposure to a person who has tested positive for coronavirus. The Department said he recently tested negative but did not offer more detail on when he was exposed.

The Trump administration is trying to cut a deal with Pfizer for more doses next year

The New York Times reports that the deal, if it goes through, would make it possible for Pfizer to supply tens of millions of additional doses next year:

Should an agreement be struck, it could at least partially remedy a looming shortage that the administration itself arguably helped create by not pre-ordering more doses of the vaccine Pfizer developed with its German partner, BioNTech. …

The administration recently asked Pfizer to sell it enough doses to cover an additional 50 million Americans, but Pfizer said it had already found customers around the world for all the doses it can produce until around the middle of next year.

In recent days, however, Pfizer has indicated that it would be able to manufacture more doses if the administration orders the company’s suppliers to prioritize its purchase requests. The two sides are now negotiating a contract under which Pfizer would provide tens of millions more doses between April and the end of June.

Americans’ willingness to get vaccinated continues to go up

According to the results of a new Kaiser Family Foundation survey released Tuesday, 71 percent of the American public now say they will probably or definitely get a COVID-19 vaccine if it’s free and deemed safe by scientists — which is up 8 percent from September. Willingness to get vaccinated rose across racial and ethnic groups, and among both Democrats and Republicans. The most dramatic increase was seen among Black adults, 62 percent of whom are now willing to get vaccinated, up from 50 percent in September.

The KFF survey also found increased enthusiasm for getting the vaccine as fast as possible, more confidence about its safety and how fairly it would be distributed, and greater optimism about when that would all happen. (71 percent of the public now believe the vaccine will be widely available by summer of next year.)

An ABC News/Ipsos poll released Monday found that 84 percent of Americans said they would get vaccinated eventually — but only 40 percent wanted to do that as soon as possible. Earlier recent polls, conducted before the FDA authorized the first COVID-19 vaccine, had found that about 60 percent of Americans said they were willing to get it.

But while more Americans continue to warm up to the idea of getting the vaccine, there are still a lot of people who say they won’t. According to the new KFF poll, 27 percent of Americans remain hesitant at best, including 15 percent who said they definitely wouldn’t get the vaccine (down from 20 percent in September), and 12 percent who said they probably wouldn’t (down from 14 percent in September). As to who these people are, per the KFF:

Vaccine hesitancy is highest among Republicans (42%), those ages 30-49 (36%), and rural residents (35%). Importantly, 35% of Black adults (a group that has borne a disproportionate burden of the pandemic) say they definitely or probably would not get vaccinated, as do one third of those who say they have been deemed essential workers (33%) and three in ten (29%) of those who work in a health care delivery setting.

And as to why they feel that way:

[The main reasons for hesitancy] are worries about possible side effects (59% cite this as a major reason), lack of trust in the government to ensure the vaccines’ safety and effectiveness (55%), concerns that the vaccine is too new (53%), and concerns over the role of politics in the development process (51%). About half of Black adults who say they probably or definitely won’t get vaccinated cite as major reasons that they don’t trust vaccines in general (47%) or that they are worried they may get COVID-19 from the vaccine (50%), suggesting that messages combatting particular types of misinformation may be especially important for increasing vaccine confidence among this group.

Only 15 percent of respondents to the new ABC/Ipsos poll said they would refuse the vaccine no matter what. That poll also found wide agreement regarding who should get vaccinated first — though less consensus about who should prioritized after that, per ABC news:

Clear majorities of Americans believe that health care workers (91%), first responders (87%), at-risk Americans with pre-existing conditions (84%), the elderly (83%), teachers (64%), and members of the U.S. military (56%) should be a high priority for accessing the vaccine.

Nearly half of those surveyed believe students (48%) and the average American similar to themselves (44%) should be a medium priority, but the public is more split on elected officials, with 41% classifying them as a medium priority and 42% ranking them as a low priority. Only athletes, of the groups asked about, were deemed to be a low priority by a majority of Americans – 58%.

Biden and Pence seem likely to get vaccinated soon

Dr. Anthony Fauci recommended on Tuesday morning that President Trump and President-elect Biden get vaccinated as soon as possible (as well as Vice-president Pence and Vice-president-elect Harris). During an appearance on ABC’s Good Morning America, Fauci stressed that giving the vaccine to the leaders wouldn’t just offer them critical protection, but send the public a valuable message about the vaccine’s importance and safety.

CNN later reported that Pence may receive the vaccine before the end of the week, likely on camera. Meanwhile Biden and his transition team said Tuesday that they are working to finalize plans for him to get publicly vaccinated as well.

Moderna expected to get FDA nod this week

As Pfizer’s vaccine continues to roll out across the country, the FDA is on the brink of granting emergency authorization for a second option. Moderna’s vaccine, which uses the same cutting-edge mRNA technology, will likely get the green light from the agency on Friday, the New York Times reports.

In a thorough review that presages an official agency decision, the FDA found that Moderna’s two-shot regimen was 94.1 percent effective in protecting against coronavirus in adults, a number that aligns with the company’s rosy but self-reported data from last month. The agency reported that the vaccine worked well no matter the recipient’s age, weight, or gender. As with the Pfizer vaccine, the data will be reviewed by an outside panel of experts later this week, which is likely to vote to proceed. The FDA is then expected to give the final go-ahead.

The Trump administration has reserved 200 million doses of the Moderna vaccine, enough for 100 million people (on top of the 100 million doses of the Pfizer vaccine it purchased). About 6 million of those doses are expected to roll out beginning next week.

Pure joy outside Boston Medical Center after the vaccine arrived on Monday

Health care workers at the hospital celebrated the COVID-19 vaccine to Lizzo’s “Good as Hell”:

Trump: White House shouldn’t get vaccine first

On Sunday evening, the New York Times reported that White House staffers would be among the first Americans to receive Pfizer’s coronavirus vaccine. The news sparked a considerable amount of consternation, considering that many members of the Trump administration have downplayed the pandemic all year, and shown little regard for public-health measures that might help contain it. (Not to mention that many White House officials, including the president, have already contracted the virus.)

But President Trump tweeted later Sunday night that he did not want his team to be first in line, and that he personally had no plans to take the vaccine:

In practical terms, it is unclear how the president’s purported preference will affect the vaccination schedule of those around him.

The White House is rolling out a last-minute vaccine education effort

In November, Health and Human Services Secretary Alex Azar delayed a public-education campaign on vaccination after Democrats opened an inquiry into the project, which involved PSAs Dennis Quaid and Billy Ray Cyrus, because representatives were concerned that phrases like “Helping the President Will Help the Country” were politicizing the effort. But now that the election is over and the distribution process has begun, the New York Times reports that HHS is reviving the $250 million project without the celebrity angle: “The new initiative will take a ‘science-based approach,’ said Mark Weber, the federal health official who is running it, and will begin this week with a first wave of advertisements in print, social media and radio, with television advertising added when the vaccine becomes more broadly available.

The White House may be getting the vaccine first, too

Intelligencer’s Matt Stieb notes a not terribly surprising development regarding who is going to get the vaccine first:

On Sunday, the New York Times reported that White House staff members, including chief of staff Mark Meadows, have been informed that they will soon receive vaccine shots. The political appointees will join high-risk, front-line medical workers as some of the first Americans to get doses of the vaccine produced by Pfizer, which was approved for emergency use authorization on December 11. It’s not yet known how many doses will be sent to 1600 Pennsylvania, though some officials told the paper that they were concerned that it may send the wrong message if they receive some of the first shots in the elaborate drive to vaccinate the nation.

Matt also points out that Meadows, of all people, is essentially an anti-poster child regarding who should get the vaccine ahead of others. (Read the rest of his post here.) Other, more pandemic-critical parts of the federal government are expected to get the vaccine this week too, a Trump administration official told CNN:

[The] official said health care providers at the National Institutes of Health will begin receiving the vaccine in the near future. Doctors and nurses in the intensive care unit at the NIH Clinical Center will be prioritized to receive the vaccine first. Other top officials, like Dr. Anthony Fauci, are on the list to receive the vaccine following those staffers who rank higher on the priority list, the official said.

What shipping the most important cargo in America looks like

Below are some images of the packing and transport of the Pfizer vaccine from a Pfizer manufacturing plant in Portage, Michigan, as well as the subsequent arrival of one of the shipments in Kentucky for distribution.

Boxes containing the Pfizer-BioNTech COVID-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant on Sunday in Portage, Michigan. Photo: Morry Gash/Getty Images
A worker pours dry ice into boxes containing the Pfizer-BioNTech COVID-19 vaccine as they are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Kalamazoo, Michigan on Sunday. Photo: Morry Gash/POOL/AFP via Getty Images
Nancy Galloway (L) and Susan Deur cheer as trucks carrying the first shipment of the Covid-19 vaccine that is being escorted by the US Marshals Service, leave Pfizer’s Global Supply facility in Kalamazoo, Michigan on Sunday. Photo: Jeff Kowalsky/AFP via Getty Images
UPS employees move one of two shipping containers containing the first shipments of the Pfizer and BioNTech COVID-19 vaccine a ramp at UPS Worldport in Louisville, Kentucky on Sunday. Photo: Michael Clevenger/Getty Images
Boxes containing the first shipments of the Pfizer and BioNTech COVID-19 vaccine are unloaded from air shipping containers at UPS Worldport in Louisville, Kentucky on Sunday. Each box contains dry ice to keep the temperature at minus 70 Celsius and contains a GPS tracker. Photo: Michael Clevenger/Getty Images

Now shipping: The first doses of GPS-tracked ultracold pandemic relief

As expected, on Sunday CDC director Robert Redfield officially accepted the recommendation of the CDC’s Advisory Committee on Immunization Practices that Pfizer’s COVID-19 vaccine could be administered to Americans over the age of 16 — which finally set shipments of the vaccine in motion. That process began first in Michigan, as the Associated Press reports:

Quick transport is key for the vaccine, especially since this one must be stored at extremely low temperatures — about 94 degrees below zero. Early Sunday, workers at Pfizer — dressed in fluorescent yellow clothing, hard hats and gloves — wasted no time as they packed vials into boxes. They scanned the packages and then placed them into freezer cases with dry ice. The vaccines were then taken from Pfizer’s Portage, Michigan, facility to Gerald R. Ford International Airport in Grand Rapids, where the first cargo plane took off amid what airport officials called a “jubilant” mood.

A small group of people gathered outside the plant to witness the trucks and their precious cargo pull out and head for the Lansing airport — tangibly kicking off the largest vaccination effort in U.S. history. Just over 184,000 doses of the vaccine left the Pfizer plant in Portage during the day on Sunday. But as the Wall Street Journal highlights, the workers, trucks, and planes involved on Sunday are just one tiny part of a massive, complicated supply chain:

The effort to vaccinate the nation relies on chemists, factory workers, truck drivers, pilots, data scientists, bureaucrats, pharmacists and health-care workers. It requires ultracold freezers, dry ice, needles, masks and swabs converging simultaneously at thousands of locations across the country. To work, every one of the many and complicated links of the chain has to hold.

In the trucks that headed to airports and distribution hubs, specially designed containers equipped with sensors monitored location, temperature, light exposure and unusual jolting. Inside, dry ice sandwiched thousands of doses of BNT162b2, the scientific name of the Covid-19 vaccine.

And a lot can and may go wrong, just hopefully never on a large scale. Here’s how Yossi Sheffi, the director of the MIT Center for Transportation & Logistics, characterized the forthcoming balancing act to the Journal:

“Everything has to come together—the packaging, the dry ice, the vials, the material itself. It all has to come together to the same place and have enough of it and exactly the right people there ready to take it … Right now, there’s no conductor to the symphony,” just many parts that each need to work.

Mistakes during rollout are inevitable

And CNN passes along a few examples of how they’ve already been happening ahead of go-time:

Colorado saw a snafu with its very first rehearsal. A test shipment of a vaccine ancillary kit containing syringes, alcohol and other supplies got shipped to another state by mistake. “This error in shipment was due to a label printing error with the manufacturer. The manufacturer has corrected the problem, but Colorado will not be receiving a second test shipment of the ‘mock’ ancillary kit,” the state said in a statement earlier this month.

One hospital system in California prepared its staff to receive vaccine in powdered form from Pfizer. Pfizer’s vaccine is, in fact, shipped as a frozen fluid that must be diluted.

“One of the challenges that has not gotten a lot of attention is that we have not factored in space in our timeline to do a lot of hands-on training with the people who will be administering these vaccines,” said Dr. Kelly Moore, associate director of the Immunization Action Coalition, which is supporting frontline workers who will administer Covid-19 vaccinations.

The last mile

The Wall Street Journal reports on how Pfizer and Operation Warp Speed partners are handling the distribution of the vaccine:

Partly [due to the ultracold temperatures Pfizer’s vaccine must be stored,] and partly for speed, the company created its own container to ship the doses while keeping them cold and secure. The company also set up its own distribution network, skipping traditional drug wholesalers in favor of logistics companies like United Parcel Service Inc. and FedEx Corp. …

CVS Health Corp. and Walgreens Boots Alliance Inc. pharmacies will deliver and administer most vaccine doses at the 15,600 nursing homes and 29,000 assisted-living communities in the U.S.

The Journal also notes that:

Hospitals slated to get shipments have been weighing difficult decisions about which employees should get vaccinated first. The hospitals have also been figuring how to give inoculated staff time off to deal with any side effects.

First vaccine shipments expected to arrive in states on Monday

The first 2.9 million doses of Pfizer’s coronavirus vaccine will arrive in states on Monday, Operation Warp Speed CEO General Gus Perna announced at an FDA briefing on Saturday. The first shipments will only reach 145 sites on Monday, he said, followed by another 425 sites on Tuesday, and 66 more on Wednesday — at which point the first distribution of vaccine doses will have been completed. The doses are being split up proportionally among states, territories, and jurisdictions according to population.

Perna warned that there would undoubtedly be logistical issues that came up during the rollout, and that the U.S. was holding 500,000 doses in reserve for emergencies or instances of spoilage — which definitely might be a factor considering the extraordinary cold at which the Pfizer vaccine must be shipped and stored. Perna also said that he still expected that a total of 40 million doses of the two-shot vaccine (enough to inoculate 20 million people) will be made available in the U.S. before the end of the month.

General Perna’s announcement directly contradicted President Trump’s remarks following the FDA’s authorization of the vaccine on Friday night, when Trump said that the vaccine was already being shipped and would begin being administered within 24 hours. Per STAT news, Perna explained that the reason the Pfizer vaccine had not been pre-shipped prior to FDA authorization was to to avoid any appearance of political motivation behind the FDA’s decision. In other words, Trump and the White House’s last-minute attempts to pressure the FDA into advancing its timeline appear to have had no actual effect on how quickly the vaccine was made available.

Key CDC panel concurs with FDA on Pfizer vaccine

The CDC’s Advisory Committee on Immunization Practices unanimously voted to recommend the Pfizer-BioNTech COVID-19 vaccine on Saturday for people 16 and older, marking the final required authorization by the U.S. for administration of the vaccine to begin. After making the recommendation, which was expected following the FDA’s emergency use authorization on Friday, ACIP chair Dr. Jose Romero underlined how carefully and seriously the expert panel had reviewed the vaccine and evaluated and confirmed its safety over a nine-month period.

“ACIP has worked to deliver a vaccine to the general public that maximizes benefits, minimizes harm, addresses issues of equity and issues of health care disparity. The deliberations have been thorough and in depth — no question that we felt was important was left unturned. All data was presented to us as we asked for it,” he said, also emphasizing that he himself would take the vaccine as soon as he was able.

The ACIP recommendation next needs to be approved by CDC director Robert Redfield, at which point the agency will publish its official guidance, including critical detailed information for states regarding how the Pfizer’s mRNA vaccine, which must be stored at ultracold temperatures, should be distributed and what those administering it need to know. Previously, the ACIP had voted to recommend that the very limited initial supply of COVID-19 vaccines be administered first to health care workers and residents of long-term care facilities. State authorities are expected to follow that non-binding recommendation, though governors will make the final call.

NPR has more details on what else the ACIP will offer guidance on, including potential side effects and allergic reactions:

While, the FDA’s assessment focused on the vaccine’s safety and efficacy standards, the CDC’s advisers also considered the practical implications of administering vaccines. At an emergency meeting Friday, prior to authorization, the CDC committee peppered Pfizer representatives with questions about the frequency of side effects and potential adverse reactions to receiving the vaccine, which could impact how vaccines get distributed in a workplace.

“We’re really concerned more about what proportion of the population may need to miss work,” said Dr. Grace Lee, an ACIP member, “For health care worker vaccination, and given where we are with the pandemic, we need to retain the capacity of our health care delivery system.” Nearly 9% of people who received the Pfizer vaccine reported side effects, including pain at the injection site, fatigue, headache and muscle pain and fevers, explained the CDC’s Dr. Sara Oliver at Friday’s meeting. These are side effects common to other vaccines, and indicate that a person’s immune system is responding to the shot.

The committee recommended the vaccine for people aged 16 and older. It’s not recommended for children younger than 16, because of a lack of data for that age group. Pfizer is currently recruiting children as young as 12 for vaccine trials. …

[The CDC’s forthcoming] guidance should clarify questions about who might be at risk for allergic reactions, and whether pregnant or lactating women should be recommended to receive the vaccine.

FDA headquarters. Photo: Sarah Silbiger/Getty Images

FDA authorizes Pfizer vaccine for human use

The Food And Drug Administration has authorized Pfizer/BioNTech’s COVID-19 vaccine for emergency use, making it the first coronavirus vaccine available in the U.S. — and marking a turning point for the pandemic in the country. As a result of the FDA authorization, 2.9 million doses of the two-shot mRNA vaccine will be distributed in the coming week throughout the U.S., where it will be administered first to health care workers and residents of long-term care facilities.

Distribution will begin as soon as Saturday, with inoculations expected to begin as soon as Monday. State and local authorities will determine where the first wave of doses go, and who gets them.

President Trump released a video on Friday night in which he emphasized the safety of the vaccine, as well as reiterated that it will be available to Americans for free. The Pfizer vaccine, which has already been authorized for use in the U.K. and in Canada, caused no serious side effects in clinical trials.

FDA expected to authorize Pfizer vaccine on Friday night, ahead of schedule

After initially planning to issue an emergency-use authorization for the Pfizer/BioNTech vaccine on Saturday, the FDA will instead do so on Friday night, the New York Times reports — though speeding up the announcement will apparently not speed up the distribution of the vaccine. The agency’s decision to accelerate its timetable followed last-minute pressure from the White House, detailed below.

Trump attacks FDA and its commissioner, who was also reportedly threatened by White House

On Friday afternoon, President Trump publicly attacked the FDA and commissioner Dr. Stephen Hahn, claiming, without evidence, that the agency was not moving fast enough to approve the Pfizer vaccine for public distribution. In a tweet, the president said the FDA was a “big, old, slow turtle,” and for Hahn to “get the dam vaccines out NOW … Stop playing games and start saving lives!!!”

In addition, according to the Washington Post, the White House threatened Hahn’s job if the FDA didn’t authorize the vaccine on Friday. Per the Post:

White House Chief of Staff Mark Meadows on Friday told [Hahn], to submit his resignation if the agency does not clear the nation’s first coronavirus vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened. …

The White House actions once again inject politics into the vaccine race, potentially undermining public trust in one of the most crucial tools to end the pandemic that has killed more than 290,000 Americans. It comes in the midst of a process that had been designed to show no shortcuts were taken in reviewing the safety and effectiveness of a vaccine as surveys show many people remain unsure whether they will get the shots.

The Associated Press later confirmed the Post’s reporting with its own sources. Both the AP and Post published a statement from Hahn disputing the idea that he was threatened. “This is an untrue representation of the phone call with the Chief of Staff,” he said. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”

This post has been and will continue to be updated to include new reporting.

Pfizer Trump Admin. Reach Deal for More Doses: Live Updates