COVID-19 Vax Facts: Pfizer and Moderna Vaccines are Here, Yet Warp Speed Shortfalls Confuse States, Continued Politicization & Reaction Watch

COVID-19 Vax Facts Pfizer and Moderna Vaccines are Here, Yet Warp Speed Shortfalls Confuse States, Continued Politicization & Reaction Watch TrialsiteN

Per NPR, 7.9 million doses of COVID-19 vaccines are ready for distribution. This includes those from the new EUA for Moderna’s product, after Pfizer’s prior EUA. Warp Speed’s chief operating officer, Army General Gustave Perna told reporters on December 19 that Moderna’s vaccine doses should arrive a sites across the nation on Monday the 21st.  “Just as we did last week with Pfizer, we are prepared,” Perna opined, “noting that Moderna had already moved its vaccine to distribution centers and that shipments would begin rolling out as early as Sunday.” In commenting on complaints from many states that their Pfizer allocations have been reduced up to 40%, Perna, “said there had been a miscommunication,” as “fewer doses were releasable than originally thought.” The general said, “When we had to decide what was going to eventually be shipped out, I had to lower the allocations to meet the releasable doses that were presented to me.” 

The General Takes the Heat

Regarding Moderna specifically, The Guardian chimed in on December 20. They note that shipments of the vaccine started that date and that inoculations were expected to take place Monday, three days after the EUA. In comparison, Pfizer-BioNtech’s vaccine was shipped one week ago. Per The Guardian, the vaccines are, “nearly all going [initially] to healthcare workers and residents of care homes, based on the advice of the advisory committee on immunization practices. There will not be shots for the general population until spring – at best.” Sunday the committee advised states to put folks over 75 and essential workers next in the line, since grocery clerks and bus drivers, for example, are most often infected. Saturday Perna said we were on track for delivery of about 20 million doses by early January, and he also apologized for shortfalls in shipments to many states. “It was my fault,” he concluded. “I gave guidance. I am the one that approved the forecast sheets. I am the one that approved the allocations, it was a planning error, and I am responsible.”

“Days of Confusion” Over Vaccine Distribution

More detail about what lead to surprise shortfalls was examined in the Sunday New York Times. They note “days of confusion” about vaccine distribution in the US, and cite top scientific advisor to Warp Speed Dr. Moncef Slaoui for the notion that a vague “administrative snafu” led to the states not being allowed to order the full number of doses that had been promised to them. 14 states or more have complained that, “they had access to far fewer doses than expected, and that the shortage disrupted their plans to distribute the vaccines,” not evidencing “Warp Speed.” Slaoui said the “problems” stemmed from “administrative holdup” and that the distribution plans had not taken last-minute FDA requirements into accounts. This may clarify an earlier Saturday apology by General Perna, who attempted to take sole blame for the shortfalls and cited “uncertainties” about manufacturers’ preparedness to ship product. Dr. Slaoui argued that FDA documentation requirements require an approval step for shipment “and that has resulted in differences between what was in the plan and what was actually done.” Slaoui confirmed the fact that on Monday the government with ship 5.9 million doses of Moderna’s vaccine and an addition two million of Pfizer’s.

Miscommunication by the General; States Confused

On December 19, Yahoo News took a look at more specifics as to General Perna’s efforts to shape the narrative on vaccine disappointments. Perna cited a “miscommunication” with states about the number of doses to be delivered in the first stages of distribution. “I failed. I’m adjusting. I am fixing and we will move forward from there,” Perna said to reported during a telephone briefing. “I want to take personal responsibility for the miscommunication,” he offered. “I know that’s not done much these days. But I am responsible. … This is a Herculean effort and we are not perfect.” He said he made errors in citing numbers of product he thought would be ready. “I am the one who approved forecast sheets. I’m the one who approved allocations,” Perna said. “There is no problem with the process. There is no problem with the Pfizer vaccine. There is no problem with the Moderna vaccine.” But Michigan’s Democratic Governor Gretchern Whitmer said the White House was “slow-walking the process,” and that its expected second Pfizer allotment was reduced from 84,825 doses to 60,000.

On Friday, the Daily Beast offered up a look at confusion at the state level about the COVID-19 vaccine rollout, noting that around the nation governors were angry and confused as to why they were set to get far fewer Pfizer doses than expected. After months of working with the federal government to pre-plan vaccine distribution, officials from Kansas, Maryland, Michigan, Missouri, Nebraska, Georgia, and Washington State, and others are being told they will get up to 30% less vaccine than agreed. And, they report being met with even more confusion when approaching federal authorities for answers. Perna is cited for his “miscommunication” explanation. He added that the time between when vaccine is produced and when they are FDA-cleared for shipment is the basis of his confusion. In one of few real details offered, Perna said that in the first week of vaccine shipment the doses had been pre-checked for quality, but in the second week this was not the case, slowing the process.

 Who Gets the Vaccine?

As noted in many outlets, including USA Today, efforts are underway to plan equitable vaccine distribution after the first priorities. Sunday a CDC panel decided that police, firefighters, teachers, and retail grocery workers should be “among those next in line” for vaccine priority. Dr. Nancy Messonnier, CDC’s director of immunization, said, “There will be difficult choice[s] about who gets the vaccine,” she told an advisory committee. Warp Speed has asserted it would distribute 20 million doses in December, 60 million in January, and 100 million by February. How this math adds up is unclear, as only about 7.9 million doses are now in the December pipeline. 

Per the New York Times headline, a “Big Fight” is brewing over who gets in line for a COVID-19 vaccines, as “Companies, unions and industry trade associations are lobbying governments to include their workers in the next round of virus vaccines.” Albany, New York lobbyist James E. McMahon has clients including a school bus company and other firms looking for early aces, notes, “Everyone is chasing the same thing now, and it really is remarkable—-The need was there and then there’s the vaccine and all of a sudden, people are saying, ‘Oh Jesus, we’ve got to get in line now.’”

Proposed Racial Consideration Ill-Advised

A goal to prioritize COVID-19 vaccines to those most vulnerable might lead to ethnic preferences, according to the Daily Mail. Per CDC guidance, each US state has been advised to consider ethnic minorities as “a critical and vulnerable group” in the context of vaccine distribution. Based on this half of the states have made plans to prioritize black, Latino, and indigenous residents, “over white people in some way.” Maine has instituted a Racial/Ethnic Minority COVID-19 Vaccination Plan in order to give preference to groups that, “have experienced rates of disease that far exceed their representation in the population as a whole.” US-wide, black and brown folks are now three times as likely as whites to die from COVID-19. CDC has recommended a focus of “racial equity” in the next vaccine recipient group, and suggested that multi-generational homes need priority. The AMA recently carried a piece suggesting that explicit racial equity programs may not pass constitutional muster. The authors suggest that race-neutral factors such as housing density, socioeconomic status, and geography be used instead of direct ethnic preferences. While America does have racial justice issues to address from its history up till nowadays in some cases, the government guidance could be perceived as unduly divisive and seems to forget that there are plenty of more appropriate factors than race in vaccine allocation.

At Least Three Severe Allergic Reactions

TrialSite reported up to five reports of significant reactions, including a few incidents at a hospital in the Midwest while two significant allergic reactions occurred in Alaska.

The Hill is reporting that, “FDA investigating allergic reactions to Pfizer vaccine reported in multiple states.” FDA Center for Biologics Evaluation and Research director Peter Marks says that reaction have been reported in at least three states and that the FDA is looking into five patient reaction cases. “We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks offered. 

Marks noted that the reactions could be caused by polyethylene glycol present in the Pfizer and Moderna vaccines. And he thinks reactions may be more common that people think. December 17, the Washington Post looked at the allergic-reaction question. They note that FDA advised no new restrictions after, “several reports of health-care workers who had a severe allergic reaction” to the Pfizer-BionNTech vaccine. Two of the incidents were in the UK and one was in Alaska. FDA is working with CDC to monitor any future reactions.  And unfortunately, “No one knows what component of the vaccine incited the anaphylactic reactions.”

Time for Greater Cohesion

Although Operation Warp Speed did in fact contribute to unprecedented vaccine development imperative, some parts of the federal government have come through but others struggle in what appears to be a lack of effective planning and execution in the product lifecycle from completion or production through distribution to administration of the vaccine at the clinic.  It’s as if in the beginning there were lots of good ideas, then promotional material and of course billions of dollars, in fact over $12.5 billion to be precise, injected into several companies as part of the public-private initiative but the actual allocation, distribution and administration of the vaccine has been struggled thus far. The hope is now that both the Pfizer and Moderna vaccines are in production, that the federal government can better orchestrate the effort with the states for an improved overall vaccination effort speed, cadence, and predictability.