Kevin Kunzmann

The first shipments of the Pfizer-BioNTech vaccine for coronavirus disease 2019 (COVID-19) in the United States left the Pfizer facility in Kalamazoo, Michigan, yesterday. With the help of UPS and FedEx, about 2.9 million doses of the vaccine were expected to be delivered to about 150 US locations today. Shipments are expected to be made to another 450 sites tomorrow and Wednesday, according to Army General Gustave Perna, who oversees the White House Operation Warp Speed project that produced the COVID-NINETEEN in record time.

And while all this is good news, even Operation Warp Speed can only move so fast and health experts warn that we won’t see any meaningful impact on American society until well into next year. Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, said recently that the country could get back to normal next summer or fall if enough people get the vaccine.

And how much is enough? Francis Collins, MD, the director of the US National Institutes of Health, says that from 70% to 80% of the public needs to be immune before we can get back to some semblance of pre-COVID normal. Collins doesn’t see that happening to around June, as well.

Meanwhile, COVID-19’s second wave continues to rack up infections, hospitalizations, and deaths, and some states have been forced once again to resort to locking down. Yesterday, the United States reported 190,920 new cases of COVID-19 and 1389 people died from the disease, according to Johns Hopkins University.

What precipitated the rollouts was the US Food and Drug Administration (FDA) granting Emergency Use Authorization (EUA) to BNT162b2, as the first vaccine for the 

prevention of coronavirus 2019 (COVID-19)

The authorization, granted to Pfizer and BioNTech, began a new stage of clinical response to a global pandemic which has afflicted more than 15 million Americans and killed 300,000 more in only 10 months.

This landmark decision also punctuated an unprecedented endeavor among pharmaceutical collaborators, clinicians, and federal agencies: the conception, creation, assessment, and regulation of a messenger RNA (mRNA) vaccine for a deadly, highly transmissible virus—again, in only 10 months.

 this week, this EUA could mark “the beginning of the end” of the COVID-19 pandemic.

The FDA and Pfizer announced that emergency authorization was granted to BNT162b2 for the prevention of COVID-19 in persons aged 16 years and older in the US.

The EUA was granted based on data from an ongoing, real-world, multinational phase 2/3 assessment of the mRNA vaccine versus placebo in the indicated age group. The data, 

 prior to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for BNT162b2 last Thursday and submitted with the EUA application in November, showed a 95% overall vaccine efficacy among treated participants without previous SARS-CoV-2 infection prior to 7 days after their second dose of the vaccine.

At the time of their EUA submission, Pfizer had reported just 8 COVID-19 cases among the 18,198 eligible participants given the vaccine, versus 162 among those given placebo.

The FDA’s authorization was also supported by the endorsement of the expert VRBPAC panel which, after a 

 scrutinizing the clinical efficacy and safety of BNT162b2, voted 17-4 with 1 abstention to support its benefit-risk profile in preventing COVID-19.

In a peer-reviewed article of the trial data published on 

 last Thursday, investigators stressed the findings carry significance beyond overall performance of the vaccine.

"The results demonstrate that COVID-19 can be prevented by immunization, provide proof of concept that RNA-based vaccines are a promising new approach for protecting humans against infectious diseases, and demonstrate the speed with which an RNA-based vaccine can be developed with a sufficient investment of resources," they wrote.

As they noted, BNT162b2 was initiated on January 10 of this year, at the time of the China government's release of the SARS-CoV-2 sequence.

"This rigorous demonstration of safety and efficacy less than 11 months later provides a practical demonstration that RNA-based vaccines, which require only viral genetic sequence information to initiate development, are a major new tool to combat pandemics and other infectious disease outbreaks," they wrote.

BNT162b2 is a nucleoside-modified mRNA vaccine which encodes SARS-CoV-2 full-length spike protein glycoprotein. Of the 4 initially assessed COVID-19 vaccines from Pfizer, it was designated for greater assessment in late July, at a two-dose regimen of 30 mcg. Just prior to that designation, the FDA granted Fast Track Designation to the candidate.

The mRNA vaccine platform is novel in regulated use, but has been under investigation for nearly 2 decades. As William Schaffner, MD, professor of Prevention Medicine at the Vanderbilt University Medical Center told 

, the expedited progression of COVID-19 mRNA vaccines including BNT162b2 and Moderna’s mRNA-1273 are preceded by 10-15 years’ worth of clinical assessment.

As Schaffner explains in the video below, the two-dose vaccine serves as a delivery of “genetic instructions” that leads to the creation of antibody response to the spike protein glycoprotein. The first and second vaccine doses have been administered 21 days apart in clinical assessment, though Schaffner stressed developed immunity would not be comprised by a “late” second dose.

“It takes about 2-3 weeks for the immune system to get primed up, then it’s ready to go,” he explained.

As per Pfizer’s available phase 2/3 data, solicited adverse events in the 7 days following vaccination were fairly common among trial participants. Common solicited local reactions included injection site pain, swelling, and redness. Common solicited systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, and new or worsened muscle joint pain.

In response to the symptoms possibly giving would-be patients pause, Schaffner stressed the impossibility of getting COVID-19 from the vaccine.

Pfizer currently projects to produce 50 million vaccine doses globally by the end of this year, then up to 1.3 billion doses by the end of 2021. The company also reached an agreement with the US Department of Health and Human Services (DHHS) to meet the US Operation Warp Speed program goal of 300 million COVID-19 vaccine doses by next year.

Through the agreement, the federal government will receive 100 million BNT162b2 doses upon EUA approval, for a cost of $1.95 billion and an option to acquire another 500 million doses.

Last week, the 15-member Advisory Committee on Immunization Practices (ACIP) voted 13-1 to prioritize frontline healthcare providers and long-term care residents—the latter being deemed most at risk of COVID-19 severity—for the first available doses of an impending vaccine.

The unique properties of BNT162b2 and the current need for expedited distribution of doses during the greatest outbreak of new US COVID-19 cases yet pose a unique challenge to Pfizer. The company stated they will ship vaccines in temperature-controlled thermal packages that can maintain a temperature of -70 degrees Celsius through dry ice.

appropriately storing and administering such vaccines could make the difference in their efficacy.

While the authorization of BNT162b2 allows for the indicated administration of the vaccine among persons in the US, assessment and monitoring pertinent to its EUA allowance will be ongoing.

As Angela Rasmussen, PhD, of the Georgetown Center for Global Health Science and Security, told 

, there is currently little to no understanding of how investigated COVID-19 vaccines influence viral loads and community transmission risk—outcomes that can only be observed in larger vaccinated populations over longer period of times.

That means a continuation of COVID-19 spread-mitigation strategies, regardless of one’s own vaccination status.

“Even if you are in the first group to get the vaccine, even if the vaccine becomes available widely beyond the first groups that are going to get it, we still need to be wearing masks, social distancing, thinking about ventilation, and avoiding large gatherings for some time to come,” Rasmussen said.

Rasmussen further stressed caution to the US public going forward—emphasizing that, while the currently available BNT162b2 safety data is certainly warranting of its EUA indication, there is likely to be newly reported adverse events associated with the vaccine once it begins to be distributed to the greater population.

Given these uncertainties circling the vaccine, as well as the rate of vaccine hesitancy or opposition in the general population, Rasmussen anticipates a resumption of normalcy—a management of COVID-19 transmission without social distancing mandates—to come in late 2021.

In the meantime, there will be more COVID-19 vaccines considered for emergency authorization. Moderna’s mRNA-1273 vaccine will undergo its own VRBPAC public hearing on Thursday, December 17, after reporting efficacy rates and a safety profile similar to that known of Pfizer’s.

2020, the same year marked by burden brought on the COVID-19 pandemic, may very well close with multiple vaccines becoming available to the US public. Experts now stress people should consider these options seriously when the opportunity for vaccination reaches them.

“Take a look at this data, listen to science and physicians, listen to people who are explaining what the data actually says,” Rasmussen advised. “So far, that data says these vaccines are safe and highly efficacious, and you should consider taking them when they’re available.”

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Angela Rasmussen, PhD: “Even if you are in the first group to get the vaccine, even if the vaccine becomes available widely beyond the first groups that are going to get it, we still need to be wearing masks, social distancing, thinking about ventilation, and avoiding large gatherings for some time to come.”

Truckloads of COVID-19 Vaccine Rolling to US Distribution Sites 

On Thursday, the US Food and Drug Administration (FDA) Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will consider the merit for the first Emergency Use Authorization (EUA) application for a 

BNT162b2, the two-dose messenger RNA (mRNA) vaccine from Pfizer and BioNTech, will undergo a full-day meeting in which its associated phase 3 data from an ongoing, multi-national assessment will be scrutinized and weighed by a panel of experts, with public input, before being voted on as either indicative of a positive or negative benefit-risk ratio for its prospective use as a preventive vaccine for confirmed COVID-19.

In short, the committee meeting on Thursday will be the US’ first public forum on phase 3 data for a COVID-19 vaccine, and will most likely preclude the first emergency authorization and immediate distribution of a vaccine for the population.

 Pfizer submitted to the FDA, as part of BNT162b2’s EUA application.

In the phase 2/3 evaluable efficacy data submitted to the FDA, the Pfizer trials’ population includes 37,796 patients, of whom 37,088 (98.1%) completed the two-dose regimen of either BNT162b2 or placebo (split 1:1). At the time of EUA submission, just 13 patients had withdrawn from assessment due to an adverse event.

The evaluable population observed for vaccine efficacy included 49.4% females, 81.9% white participants, 9.8% African American participants, 4.4% Asian participants, and <3% from other racial groups. Another 26.2% of participants were of Hispanic/Latino descent, and 21.4% were ≥65 years old.

Median participant age was 51 years, and frequently reported comorbidities included obesity (35.1%), diabetes (8.4%), and pulmonary diseases (7.8%). More than three-fourths (76.7%) of participants were from the US.

Overall, comorbidities were reported in 46.2% of all observed patients. Just 545 patients administered BNT162b2 had baseline evidence of previous SARS-CoV-2 infection.

Investigators sought a primary endpoint of vaccine efficacy for BNT162b2 against confirmed COVID-19 in participants without evidence of prior SARS-CoV-2 infection prior to 7 days after their second dose.

The second primary efficacy endpoint included vaccine efficacy of the candidate against confirmed COVID-19 in participants with and without such prior infection evidence. Investigators counted cases from 7 days after dose 2 for both endpoints, as that is the suggested time to developed immunity.

Among participants without previous SARS-CoV-2 infection prior to 7 days after their second dose of BNT162b2, vaccine efficacy against confirmed COVID-19 at least 7 days following their second dose was 95% overall (95% CI, 90.3 – 97.6). Investigators observed just 8 COVID-19 cases in the treatment group, versus 162 cases in the placebo group.

Vaccine efficacy in this participant population was slightly greater for those aged 16-55 years old (95.6%; 95% CI, 89.4-98.6) than those >55 years old, who are deemed at greater risk of COVID-19 severity (93.7%; 95% CI, 80.6-98.8).

In the second primary endpoint including participants with and without prior SARS-CoV-2 infection before and during vaccination regimen, vaccine efficacy at least 7 days after dose 2 was 94.6% (95% CI, 89.9-97.3). Again, the rate of COVID-19 cases among vaccinated patients (n = 9) versus placebo (n = 169) was substantial.

Investigators again observed a slightly improved vaccine efficacy rate among patients 16-55 years old versus >55 years old in this population.

In subgroup analyses—in which “at risk” is defined as having at least 1 of the Cahrlson comorbidity index items or a body mass index (BMI) of ≥30, indicating obesity—the vaccine was associated with a 95.4% efficacy among individuals at risk of COVID-19 severity (95% CI, 87.8-98.8). Though the population was too small to perceive absolute interpretability, at-risk participants aged ≥65 years were associated with a 91.7% vaccine efficacy (95% CI, 44.2-99.8).

The key secondary endpoint of severe COVID-19 cases was observed in just 4 participants following ≥7 days after the second dose. Among them, just 1 had received BNT162b2. That said, the FDA noted the participant was not hospitalized, did not seek further medical care, and did not have risk factors for severe disease; the participant’s severe diagnosis was based on oxygen saturation levels of 93% at clinical visit.

In the phase 2/3 safety population, investigators indeed observed a greater proportion of vaccine recipients reporting adverse events versus placebo recipients, largely driven by solicited adverse events in the 7 days following vaccination, as well as unsolicited adverse events corresponding to reactogenicity symptoms among participants not in the trial’s reactogenicity subset.

That said, investigators observed a balance of rates of serious adverse events, deaths, and trial withdrawals among the treatment groups.

Regarding solicited local reactions among participants aged 18 years and older, injection site pain was the most frequently reported event; it was more frequently reported among younger patients after the second dose of BNT162b2, and was generally characterized as moderate. Injection site swelling and redness were reported far less frequently among participants, and similarly across age groups.

Regarding solicited systemic events including fever, fatigue, headache, chills, vomiting, diarrhea, and new or worsened muscle/joint pain, frequency was greater again among younger patients. Participants overall experienced more frequent and more severe systemic adverse events after dose 2.

Among all age groups, the most common events were fatigue, headache, and new or worsened muscle pain.

Regarding unsolicited non-serious adverse events, investigators observed an imbalance of lymphadenopathy (n = 64) cases in vaccinated patients versus placebo (n = 6), as well as 4 vaccinated cases of Bell’s palsy.

“The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time, but FDA will recommend surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations,” they wrote.

Investigators also reported 3 serious adverse events in the BNT162b2 group related to the vaccine itself: shoulder injury, ventricular arrhythmia, and lymphadenopathy. Six total trial participants died during the trial; 2 being from the vaccine group. One patient experienced cardiac arrest 62 days following their second dose and died 3 days later; the other died from arteriosclerosis 3 days after the first dose.

“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” the FDA wrote.

Lastly, investigators reported no specific safety concerns by participant age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection. Pregnancy outcomes only included 23 female participants through the trial cut-off date of November 14, and are otherwise unknown beyond a couple of unsolicited adverse events to occur in the placebo group.

From Thursday morning through the early evening, an advisory panel consisting of FDA experts will host an open session to discuss Pfizer’s EUA for BNT162b2, for the prevention of COVID-19 in-persons aged 16 years and older.

 features opportunities for open public hearings, Q&A sessions at the conclusion of set presentations, and finally, a committee discussion and voting period on the merit of the EUA.

Planned sessions, as per the FDA’s shared agenda, include:

Vaccine safety and effectiveness monitoring

Considerations for a trial design if an unlicensed vaccine becomes available

In the history of the FDA, advisory committee votes have very frequently aligned with eventual marketing decisions. There is anticipation—given the nature of the COVID-19 pandemic and collaboration between federal agencies, vaccine developers, and manufacturers to mitigate risks—that EUA approval and BNT162b2 distribution could shortly follow the VRBPAC decision.

, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) granted emergency use authorization for BNT162b2. Prioritized patients in the UK have begun receiving their first dose of the vaccine this week.

The FDA’s Related Biologic Products Advisory Committee meeting on Thursday will be the US’ first public forum on phase 3 data for a COVID-19 vaccine, a possible prelude to approval.

FDA Shares Phase 3 Pfizer COVID-19 Vaccine Data

Moderna is submitting its application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) o 

The submission, anticipated for Monday, would initiate a timeline which may see the mRNA platform vaccine become available for the US public as early as December 21 if the FDA finds safety and efficacy evidence to be substantial for approval.

The FDA will now decide on 2 COVID-19 vaccine EUA applications in December, including 

Pfizer’s own mRNA vaccine candidate, BNT162b2.

mRNA-1273 was co-developed by biotechnology company Moderna and the National Institutes of Allergy and Infectious Diseases (NIAID) Vaccine Research Center—a product first completed as a clinical batch in the first week of February, and undergoing phase 1 clinical by March 16.

As a nucleoside-modified messenger RNA (mRNA) platform-hosted vaccine, it is encoded for a prefusion stabilized form of the SARS-CoV-2 Spike protein, based on the virus’ sequencing provided by Chinese investigators at the beginning of the COVID-19 outbreak. NIAID director Anthony Fauci explained to sister publication 

 in a podcast interview this September that the concept of the vaccine was borne on January 11—just 1 day after the SARS-CoV-2 sequence was made public.

“I got my team together on the 11th (of January) and said, ‘We’ve got to partner with Moderna and put this in an mRNA platform.’ By the 15th, we started doing it,” he explained. “Sixty-five days later, we were in a phase 1 trial. And 7 months later, we’re in a phase 3 trial. That process would normally take a few years, but we didn’t compromise anything.”

The vaccine is currently being assessed in the ongoing phase 3, randomized, placebo-controlled COVE trial, in which a 100 mcg dose of mRNA-1273 is being compared versus placebo across 30,000 US adults aged 18 years and older.

The primary endpoint of assessment is preventing symptomatic COVID-19 disease with the vaccine, while key secondary endpoints including preventing severe forms of the virus, and overall infection by SARS-CoV-2.

As developed under guidance from the FDA and the National Institutes of Health (NIH), the COVE study additionally includes 7000-plus participants over the age of 65 years, as well as 5000-plus participants with chronic diseases including diabetes, severe obesity, and cardiac disease—both indicators of high severe COVID-19 risk.

Currently, these high-risk groups represent 42% of all observed patients in the phase 3 trial.

The newest data reported by COVE investigators indicated that mRNA-1273 is associated with a 94.1% efficacy rate, based on the benchmark of 196 total COVID-19 cases in the trial population.

Efficacy against severe COVID-19, however, remained at 100%—based on the benchmark of 30 total severe cases, all in the placebo group.

Investigators additionally reported consistent efficacy across patient age, race and ethnicity groups, as well as gender demographics.

Currently, the safety profile of mRNA-1273—which is under continuous review—has shown no new serious safety concerns in treated participants, and common adverse reactions including injection site pain, fatigue, myalgia, arthralgia, headache, and erythema at the injection site. The frequency and severity of such anticipated reactions were raised after the second injection of the two-dose vaccine.

Moderna investigators will submit the phase 3 data for publication in a peer-reviewed journal shortly.

Stephane Bancel, chief executive officer of Moderna, said the primary analysis of COVID-19 prevention—as well as severe COVID-19 prevention—was confirmed by the newest efficacy rate reported.

“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,” Bancel said in a 

. “I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus.”

Accompanied with the news of the EUA submission is the expectation the FDA will host a Vaccines and Related Biological Products Advisory (VRBPAC) meeting for mRNA-1273 on Thursday, December 17.

The intent of the meeting is for members of the FDA committee to host a discussion on the vaccine’s supporting data, before submitting their vote to either support the EUA or not—an outcome that is very historically tied to final FDA decisions.

The VRBPAC meeting is scheduled for 6 days following the planned discussion for Pfizer’s BNT162b2, which may provide clearer indication as to how Moderna’s product will be perceived and scrutinized by the panel of experts.

Following (potentially) VRBPAC support and corresponding emergency authorization, Moderna would be ready to ship approximately 20 million doses of two-dose mRNA-1273 through the US by the end of the year, with priority being recommended by the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP).

Moderna—which worked with the CDC, Operation Warp Speed, and federally-contracted COVID-19 vaccine distributor McKesson to be prepared for immediate manufacturing and distribution in the event of an EUA—is on track to manufacture 500 million to 1 billion doses for a global population in 2021.

Prioritization of one vaccine versus another—particularly in the case of similar platform candidates being produced by the major industry player Pfizer and expert-guided newcomer Moderna—is not something experts anticipate unless future long-term safety assessment indicates otherwise.

 that mRNA-1273’s early effect on T-cell activation and triggered antibody response in its older participant population, as well as its involvement with Fauci and NIAID, gives it a unique leg up in potential versus the Pfizer vaccine.

Efficacy against severe COVID-19 is 100%—based on the benchmark of 30 total severe cases, all in the placebo group. Consistent efficacy was seen across patient age, race and ethnicity groups, as well as gender demographics.

Moderna Submits COVID-19 Vaccine for FDA Approval

Pfizer will be the first company considered for authorization of a 

The global biopharmaceutical company will submit an 

Emergency Use Authorization (EUA) application

 to the US Food and Drug Administration (FDA) today for its COVID-19 vaccine candidate BNT162b2.

The submission comes in the days following announcement from Pfizer and partnering company BioNTech that their phase 3 trial assessing the two-dose mRNA vaccine achieved all its primary efficacy endpoints without any serious adverse events thus far observed in the 43,000-plus global participants.

If authorized by the FDA, as anticipated following a public advisory committee meeting in the coming weeks, Pfizer plans to have tens of millions of doses ready for prioritized distribution and administration by the new year—and more than 1 billion doses to follow in 2021.

BNT162b2 is a nucleoside-modified messenger RNA (mRNA) vaccine which encodes SARS-CoV-2 full-length spike protein glycoprotein. Of the 4 initially assessed COVID-19 vaccines from Pfizer, it was designated for greater assessment in late July, at a two-dose regimen of 30 mcg.

The mRNA platform, which is also used by biotechnology company Moderna’s COVID-19 vaccine candidate mRNA-1273, has been touted by experts including Anthony Fauci, MD, director of the National Institutes for Allergy and Infectious Diseases (NIAID), who told sister publication 

 earlier this year it is responsible for the rapid development and assessment of COVID-19 vaccines these last 10 months.

The FDA granted Fast Track Designation to Pfizer and BioNTech for BNT162b2 in mid-July.

Data shared by Pfizer and BioNTech from their four-month, phase 3 global trial showed BNT162b2 was 95% effective in preventing SARS-CoV-2 infection in treated participants regardless of prior infection, in every case measured 7 days following the second dose (

The trial began on July 27, and has thus far enrolled 43,661 participants, of whom 94.7% have received their second dose. Patients were randomized to either BNT162b2 or placebo at baseline.

As of this week, Pfizer reported that 42% of global participants and 30% of US participants have ethnically diverse backgrounds, and that similar rates (41% and 45%, respectively) consist of patients 56-85 years old. Their approximate 150 clinical trial sites enrolled patients from 6 countries: US, Germany, Turkey, South Africa, Brazil and Argentina.

Investigators reported the outcomes based on 170 total confirmed COVID-19 cases in the trial population—162 having been observed among placebo patients, and just 8 among patients to receive BNT162b2.

Among adults over 65 years old—a critically at-risk patient population for COVID-19 severity—the vaccine efficacy was 94%.

Just 1 of 10 observed severe COVID-19 cases in all patients occurred in the vaccinated group. Investigators stated BNT162b2 efficacy was consistent across age, gender, race, and ethnicity demographics.

Two weeks prior, Pfizer submitted data to the independent Data Monitoring Committee for their assessment of serious safety concerns associated with the vaccine. Currently, no such concerns have been reported.

Investigators reviewed unblinded reactogenicity data from the final phase 2/3 analyses for BNT162b2 involving 8000 random participants. Their findings indicated a generally good tolerance of the vaccine, with most reported adverse events resolving shortly after administration. Fatigue (3.8%) and headache (2.0%) were the only severe adverse events to occur in at least 2% of participants after the second dose.

 the FDA released a guidance for COVID-19 vaccine developers, stating phase 3 trial data included in EUA applications should include a median patient follow-up duration of at least 2 months following their final dose, to assure a clear benefit-risk profile.

Though the FDA must first clear BNT162b2 for regulation, distribution strategies are underway by Pfizer. It currently projects to produce 50 million vaccine doses globally by the end of this year, then up to 1.3 billion doses by the end of 2021.

They also announced on November 16 the launch of the US COVID-19 Immunization Pilot Program, which will use feedback and observations made from delivery and deployment practices in 4 initial states to adapt greater national vaccine distribution strategies.

The 4 states—Rhode Island, New Mexico, Tennessee, and Texas—provide Pfizer differing population sizes and diversity, as well as varying state immunization structures and disparities in urban-rural makeup.

The pilot program does not indicate these 4 states will receive differential treatment in vaccine distribution, nor earlier providence of vaccines.

Pfizer reached an agreement with the US Department of Health and Human Services (DHHS) to meet the US Operation Warp Speed program goal of 300 million COVID-19 vaccine doses by next year. Through the agreement, the federal government will receive 100 million BNT162b2 doses upon EUA approval, for a cost of $1.95 billion and an option to acquire another 500 million doses.

The unique properties of the mRNA vaccine and the current need for expedited distribution of doses during the greatest outbreak of new US COVID-19 cases yet pose a unique challenge to the company, experts have observed. Pfizer stated they will ship vaccines in temperature-controlled thermal packages that can maintain a temperature of -70 degrees Celsius through dry ice.

’s, appropriately storing and administering such vaccines could make the difference in their efficacy.

With the FDA having now been provided phase 3 data and other required materials in the EUA application, they will deliberate on the clinical portfolio, properties, and necessity of BNT162b2 before granting authorization.

Pfizer anticipates a public Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to discuss the vaccine’s data will be scheduled for December. The committee members will vote to either support FDA authorization or not—an outcome very historically tied to final FDA decisions.

Pfizer also anticipates its EUA will be specific to US populations at higher COVID-19 risk, as defined by the US Centers for Disease Control and Prevention (CDC), and supported by the promising phase 3 outcomes observed in such populations.

“We believe the priority will be frontline healthcare workers, essential workers, immunocompromised individuals, nursing homes, and public safety officials, but ultimately it is the governments that will make this determination,” Pfizer wrote in a statement.

recent episode of the Vaccine Race podcast

, William Schaffner, MD, professor of Preventive Medicine and Medicine at the Vanderbilt University Medical Center, explained a number of particularities surrounding BNT162b2 storage, distribution, and administration.

Namely, he depicted a scenario of state-organized, temperature-controlled tractor trailer convoys delivering first and second doses of the vaccine in successive waves to facilities including hospitals and nursing home facilities throughout the US.

“We’re going to have to do this in stages,” Schaffner said. “Logistically, this is going to be very challenging.”

On the front of strategic prioritization—toward a goal of achieved herd immunity through appropriate vaccination—Schaffner discussed how recent models suggest there is a slight advantage in reduced overall mortalities immunizing the highest-risk patient populations first.

But he maintained the priority would begin with healthcare workers, who would then help to vaccinate the general population.

“I think either essential workers or people at highest risk will be second in line,” Schaffner said. “The (CDC Advisory Committee on Immunization Practices) hasn’t quite decided which is which. Most other external groups have put an emphasis on vaccinating those at greatest risk next.”

The submission comes in the days following announcement from Pfizer and partnering company BioNTech that their phase 3 trial assessing the two-dose mRNA vaccine achieved all its primary efficacy endpoints.

Kevin Kunzmann

Articles

Truckloads of COVID-19 Vaccine Rolling to US Distribution Sites

FDA Shares Phase 3 Pfizer COVID-19 Vaccine Data

Moderna Submits COVID-19 Vaccine for FDA Approval

Pfizer Submits COVID-19 Vaccine to FDA for Emergency Authorization