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Earlier this month, Pfizer became the first COVID vaccine maker in the U.S. to apply for full licensing from the U.S. Food and Drug Administration (FDA). In the wake of that announcement, Peter Doshi, senior editor of The BMJ, published an article questioning the wisdom of rushing the vaccine to full approval on the basis of only about six months’ worth of data.
Doshi pointed out that one key difference between the Emergency Use Authorization (EUA) granted by the FDA to Pfizer, Moderna and Johnson & Johnson COVID vaccines, and approval — also called “licensure,” or for vaccines, Biologics License Application (BLA) — was the expected length of follow-up of trial participants.
For EUA, the FDA requires two months follow-up of clinical trial participants, but the agency has not committed to a clear minimum follow-up requirement for full approval, Doshi said. When the question was raised during a Dec. 10, 2020, FDA meeting, Doshi reported that the FDA’s Doran Fink responded that the agency “typically asks” for “at least six months of follow-up in a substantial number of clinical trial participants to constitute a safety database that would support licensure.”
“An approval based on six months of data would represent one of the fastest for a novel vaccine in FDA history. Among the six ‘first in disease’ vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis.
“Six months also seems substantially shorter than previously conceptualized expectations. A World Health Organization expert group on COVID-19 vaccines (which included FDA regulators) in August 2020 called for follow-up ‘until at least month 12, or until an effective vaccine is deployed locally.’ Another group, composed of industry and academic authors, similarly wrote in October 2020: ‘we recommend longer term follow-up of all participants … for at least a year after randomization.”
Doshi said in its formal guidance, issued in June 2020, the FDA said it wanted participants followed for COVID outcomes for “as long as feasible, ideally at least one to two years” after the first injection.
“But the same document states that safety assessments for ‘serious and other medically attended adverse events should be studied ‘for at least six months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms,’” Doshi wrote.
When the BMJ reached out to the FDA for clarification, a spokesperson responded: “We do not have any further information beyond what is in the guidance document.”
What about ‘vital’ data?
How long vaccines protect against the virus isn’t the only question that longer, placebo-controlled trials can address — they also address vaccine safety, Doshi wrote.
Doshi said: “there is a gap — currently of unknown size but growing — between any expectation of blinded placebo controlled data, and the reality that within weeks of the vaccines receiving an EUA, the unblinding of trials commenced as placebo recipients were offered the chance to get vaccinated.”
The BMJ asked Moderna, Pfizer, and Janssen (Johnson and Johnson) what proportion of trial participants were now formally unblinded, and how many originally allocated to placebo have now received a vaccine. According to Doshi, Pfizer declined to say, but Moderna announced that “as of April 13, all placebo participants have been offered the Moderna COVID-19 vaccine and 98% of those have received the vaccine.”
“In other words, the trial is unblinded, and the placebo group no longer exists,” Doshi wrote.
Johnson & Johnson/Janssen told The BMJ: “We do not have specific figures on how many of our study participants have received a vaccine at this time.”
But the company confirmed it was implementing an amended protocol across all countries to unblind all participants in its two phase 3 trials, the earlier of which passed the median of two month follow-up mark in January, according to Doshi.
Doshi said it’s unclear how the FDA will “weigh the loss of blinding- and placebo- controlled follow-up, but just months ago the agency said these trial properties were vital.”
What’s the rush?
The BMJ asked vaccinemakers why they were seeking full approval now, given that the lack of full licensing hasn’t created a barrier to access.
Moderna did not respond and Janssen only confirmed it intended to apply for a BLA “later in 2021.” Pfizer likewise did not answer but instead quoted an FDA webpage on medical devices, which stated: “Sponsors of EUA products are encouraged to follow up the EUA with a pre-market submission so that it can remain on the market once the EUA is no longer in effect.”
But EUAs have no built-in expiration date, Doshi argued, citing 14 EUAs for Zika diagnostic tests that remain active despite the fact that the public health emergency they were intended to address ended in 2017.
Doshi also raised concerns about the lack of biodistribution studies on the EUA vaccines. He wrote:
“Officials have consistently emphasized that despite shaving years off traditional timelines for producing vaccines, no compromises in the process were taken. However one type of study, tracking the distribution of a vaccine once injected in the body, was not conducted using any of the three vaccines currently authorized in the U.S.”
Doshi said biodistribution studies are a standard element of drug safety testing but “are usually not required for vaccines,” according to European Medicines Agency policy, which adds, “However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients.”
Pfizer and Moderna did not respond to The BMJ’s questions regarding why no biodistribution studies were conducted on their novel mRNA products, and none of the companies, nor the FDA, would say whether new biodistribution studies will be required prior to licensure,” Doshi wrote.
Readers respond to Doshi
A number of people posted responses to Doshi’s article on The BMJ website. Below are two of the responses, posted in full.
Letter from Bernadette Pajer, public policy director of Informed Choice WA in Washington State:
Dear Peter Doshi,
Thank you for your coverage of COVID-19 and for sharing your critical thinking on serious issues.
It is my contention that two new aspects of the rollout of the Pfizer EUA product have risen to the level of reckless endangerment, and I am hopeful you will explore this and provide your thoughts.
On May 12, 2021, the United States Advisory Committee on Immunization Practices (ACIP) voted to recommend the investigational Emergency Use Authorization (EUA) Pfizer shot to children ages 12 to 15. They also voted to end restrictions around co-administration with other vaccines even though there has not been a single clinical trial administering any of the shots with any other vaccine.
Why are young teens being targeted with EUA shots? And why allow co-administration?
This is an age group that does not tend to be susceptible to severe infection, and CDC says from March of 2020 through April 2021, those aged 12-17 made up just 9% of the reported cases and a total of 127 deaths. As with adults, children with underlying health issues are more at risk. Most children experience low to no symptoms and several studies now show that natural immunity is robust and likely long-lasting.
There are concerns that some children infected with SARS-CoV-2 are experiencing multisystem inflammatory syndrome (MIS-C). As of May 3, 2021, there have been 3742 cases, the majority of which recovered, but 35 were fatal.
A case study says:
“MIS-C is considered to be caused by a late response to SARS-CoV-2 infection, as some patients have a negative RT-PCR but a positive IgM/IgG serology, highlighting the involvement of aberrant innate immunity as the main mechanism. There is also evidence that antibodies to SARS-CoV-2 accentuate the disease through a facilitating mechanism that enhances viral entry or antibody replication as has been observed in dengue.”
Why is that important in regards to the Pfizer shot in children? Because the Pfizer shot, along with Moderna and the Janssen/J&J shots, all work by getting the recipient’s own cells to make a synthetic, genetically altered, stabilized version of the part of the virus now known to cause the most severe outcomes — the spike protein — and this means extreme caution should be taken with vaccine administration. The recipient’s immune system creates antibodies to that spike protein. Will antibodies to the vaccine-induced spike protein cause MIS-C in some children? We have no idea. The study was far too small to catch rare outcomes.
While we of course want to protect children from severe disease and from MIS-C, there is zero evidence any of the shots are capable of doing this, or if they will instead cause these outcomes. What should be done is to look for underlying factors for why some children are experiencing severe disease or MIS-C after exposure to the virus so we can better protect and recover them. Obesity has been associated with both, and obesity is associated with low Vitamin D levels.
COVID-19 treatments are available and early treatment saves lives. Doctors around the country and around the world are calling for early treatment. Why are the CDC and NIH still silent on early ambulatory treatments?
The ACIP’s change of guidance to now allow co-administration adds another potential danger. Again, not a single study was done, not even in animals, to see if it is safe to give the Pfizer mRNA shot with any other vaccine.
After the vote, some ACIP members gave their reason.
They only had one. They don’t want to miss an opportunity to vaccinate.
That’s it. Science be hanged, safety unknown, by gosh, they didn’t want doctors to miss an opportunity to give other vaccines.
What happens when a 12-year-old is injected with Gardasil with its highly reactogenic aluminum AAHS adjuvant in one arm and the Pfizer mRNA shot in the other? What happens when the child’s cells begin pumping out spike protein in the presence of an adjuvant that is revving up their immune system to go on the attack?
We have no idea.
What on earth were the members of the ACIP thinking? Why would they make a recommendation allowing for co-administration based on zero safety science?
FiercePharma, the drug industry’s insider online magazine, provided a likely answer within hours of the ACIP’s vote:
“As revenues for several Big Pharma players slumped to start the year, execs blamed part of the problem on the accelerating COVID-19 vaccine rollout. The CDC had recommended people don’t get another shot within two weeks of their COVID-19 vaccine, hitting sales for key products.
“Now, the CDC is doing away with that suggestion entirely in an effort to boost routine immunizations among teens. The move could spell financial rewards for leading vaccine companies such as Merck, GlaxoSmithKline and Pfizer.”
This is not science.
With all major and social media companies censoring anything critical of the COVID-19 vaccines, how can parents be warned about this lack of safety science? How many children will be harmed before it is stopped?
Letter from John Stone, UK editor of Age of Autism in London:
Many thanks to Peter Doshi. An important question not asked in this excellent article but certainly begged is how can we have allowed the manifold political, institutional and social pressures to build on individuals to receive these products in the absence of definitive science (or manifestly anything approaching it), meanwhile throwing sand in the eyes of informed consent — which is certainly an essential legal requirement in the UK — and the Nuremberg Code.
We are beset on all sides by people: politicians, mainstream media, celebrities (people of no professional accountability for these products but ready to assure us of their safety and efficacy in the absence of data or deep knowledge). Have we become more wise than previous generations or more foolish?
And in the end, when it comes to licensure, with so many powerful people endorsing these products – not to mention the popular desire stoked by these pressures – how will we be able to distinguish between institutional integrity and wish-fulfillment? Will we be prepared to look squarely at the harms these products may have done or their fallibility, just because we want to escape the pandemic?