The latest iteration of the mRNA COVID vaccine boosters from Pfizer and Moderna, designed to target the Omicron XBB.1.5 subvariant which was dominant throughout much of the world this past spring, will be available soon at major pharmacies and health centers after being greenlighted by the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) earlier this week.
This will be the third COVID booster jab offered to Americans considered low-risk (the fifth for high-risk groups since 2021) and the first time since the World Health Organization (WHO) and Biden administration unscientifically ended the COVID-19 public health emergency (PHE) declarations last May. One of the factors motivating this decision was to shift the provision of the vaccines to the private market, with companies now able to charge marked-up prices.
Criminally, the list price of the vaccines, which were developed through federal programs funded by taxpayers, is now $110 to $130 per dose. While in theory most people with private and public health insurance should have these costs covered, there will undoubtedly be bureaucratic loopholes that make this difficult for millions, forcing many to pay out-of-pocket. For those without insurance, they will have to navigate community health centers, while provision through the Biden administration’s “Bridge Access Program” remains unclear.
On Tuesday, the Advisory Committee on Immunization Practices (ACIP) voted nearly unanimously (13-1) to recommend the jabs for all Americans six months of age or older. CDC Director Dr. Mandy Cohen signed off on these recommendations hours after the vote. Novavax’s protein-based COVID vaccine directed at XBB.1.5 awaits regulatory approval in the next few weeks but should receive similar CDC recommendations for eligibility.
In a statement released by the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks said:
Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death. The public can be assured that these updated vaccines have met the agency’s rigorous scientific standard for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.
These reformulated mRNA, or protein-based vaccines, do not require new clinical trials as their safety has been previously determined. Indeed, in the almost three years they have been employed, they have proven their safety profiles with very rare cases of anaphylaxis or deaths associated with the vaccines.
According to the CDC’s “Reported Adverse Events,” with hundreds of millions of COVID vaccines administered, anaphylaxis occurred in about five cases per 1 million vaccine doses given. Multiple studies have yet to demonstrate any unusual patterns in cause of death after vaccination [See Link 1, Link 2, Link 3, and Link 4]. In fact, for those who have been vaccinated for COVID-19, all-cause mortality was lower than the expected all-cause mortality rates.
As for vaccines causing inflammation of the heart, known as myocarditis, one study found there were potentially 320 such cases out of nearly 7 million vaccine doses among persons 5-17 years old within 98 days of vaccination.
Regarding adolescent males, although the rates of myocarditis caused by the mRNA vaccines are higher than background, they are still very rare events, amounting to only 22.4 excess cases per million with Pfizer and 31.2 excess cases per million with Moderna. Most of these were reported to be transient in nature and were cleared by their physicians for all physical activity. However, the most recent data collected on the last bivalent booster among more than 110,000 vaccine doses given to those 12-17 years old found that there were zero case of myocarditis.
Data obtained in the laboratory setting also indicate that the new booster shots produce a significant immune boost protecting against the latest Omicron subvariants that are circulating, including the highly-mutated and divergent BA.2.86 (Pirola) lineage. Meanwhile, real world data with the previous iteration of the COVID boosters found that they provide better protection against hospitalization than the original COVID booster based on the wild-type strain of the coronavirus. The implication is that these new iterations will improve a person’s immune response against the latest viral strains.
The near universal recommendations by the ACIP came as some surprise by many who expected the COVID boosters might be limited to high-risk populations in the face of high levels of population immunity from previous infections and vaccinations. This more restrictive approach is being implemented in the UK, some EU countries, China and Mexico, where they will be prioritized to the elderly and most vulnerable, including immunocompromised individuals, nursing home populations and those with medical comorbidities. Germany, for instance, is not running any winter campaign efforts though they are recommending annual boosters for at-risk groups.
The basis for the universal recommendations came from the CDC’s own analysis that if provided to the entire population then 400,000 hospitalizations and more than 40,000 deaths could be averted over the next two years. These facts raise inconvenient truths about the nature of the pandemic and the health agency’s cavalier and negligent response to the latest ongoing surge of infections and hospitalizations across the US.
Important information gleaned from the presentation suggests that the CDC expected the reformulated vaccines to offer 65 percent vaccine efficacy against symptomatic infection. As usual, immunity should reach its highest point after one month and then begin to rapidly wane over the intervening four to six months. This would place most people at risk of infection or hospitalization after the winter surge has receded, presuming they are vaccinated in the weeks ahead.
Nonetheless, the CDC anticipates that weekly hospitalizations will climb over the winter and reach last year’s range of admissions. They acknowledged that persons from six months of age to 49 years without underlying medical conditions were still being admitted to the ICU or dying with COVID-19 in the period from July 2022 to June 2023.
COVID-associated deaths in the US during the first seven months of 2023 were 451 for ages 20 to 44; 2,821 for those 45 to 64 years old; and 24,776 for those over 65. Additionally, 80 infants, children and young adults died from COVID-19 during this period. In total, more than 28,000 have died from COVID in the first half of 2023, which is considered an undercount as they are based on how these deaths are coded.
Upending all the lies that COVID-19 is “like the flu” and does not impact children, in the first seven months of 2023 the flu only killed 28 people in the US between the ages of one and 19, while during the same period 54 died of COVID in the same age range. While data for flu deaths under 12 months of age was not provided, 26 COVID deaths officially took place among those less than one year old.
When the CDC reviewed risks based on the number of underlying medical conditions and the increased risk of admission to the ICU, mechanical ventilation and death, the hazard ratio jumped dramatically for one condition and then again for those with more than one condition, underscoring the considerable risk most people with poor health face in the US and the rest of the world face when infected with COVID-19.
In contrast to the Biden administration’s propaganda that “the pandemic is over,” in summarizing their findings the CDC refers to the current surge as a “pandemic” and notes that “the absolute number of hospitalizations and deaths is still high.” They found that the most vulnerable—infants and older adults—have the highest COVID-19-associated hospitalization rates, and they anticipate that this winter COVID-19 will continue to impact healthcare systems.
These findings are vital for the population, and one must ask why these have not been provided in such a cogent manner? Additionally, why are these vaccines just being offered when a surge has been underway for the last three months? Why haven’t public health measures been implemented to protect people from the ravages of the virus with the impact it causes on every organ system in their body, increasing one’s risk of diabetes, heart disease and stroke which are not being counted in these metrics?
Weekly hospitalizations for COVID have risen three-fold since late June and as of the week ending September 2, 2023, stand at 18,871. Weekly deaths, a lagging indicator, have also been inching higher at 672 as of August 12, 2023, which are up 40 percent from early July. The fact that these unreliable data are a month old means that using these metrics will have little impact in protecting the population should the virus evolve into a more virulent form.
Currently, the latest Biobot Analytics data on SARS-CoV-2 wastewater levels updated on September 11, 2023, indicate that the current national surge continues, corresponding to approximately 720,000 COVID infections each day.
Recent experience with the lackluster uptake of the bivalent COVID boosters indicates that many may choose to forgo this life-saving preventative measure. This is not an individual failure but a public health disaster, the product of a bipartisan propaganda campaign of the capitalist ruling elites designed to condition people to ignore the threats posed by SARS-CoV-2.
Workers should take every measure to acquire these treatments and protect themselves and their families, even though the vaccines alone do not guarantee against COVID-19 infection or Long COVID. The vaccine-only strategy of the Biden administration is fundamentally a flawed public health approach and dangerous. Still, under the present circumstances, it is vital to protect one’s health and well-being as much as possible.
The CDC’s universal recommendation for the new booster shots is correct but does not stem from a shift in their perspective or policy to inure the population to treat COVID like another seasonal virus.
A global elimination strategy, based on international cooperation and initiative in the deployment of all available public health measures, remains the only real solution to the pandemic. Such a strategy to protect billions of people all over the planet can only be implemented through the socialist reorganization of the global economy, which would also enable mankind to addres all the urgent crises borne out of the chaos of capitalist production.
Someone from the Socialist Equality Party or the WSWS in your region will contact you promptly.