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Unapproved Pfizer vaccine mass-shipping to US despite promise to wait for green light from FDA

The Food and Drug Administration’s guidelines forbid pharmaceutical companies to send vaccines to distribution sites such as hospitals until they have been approved. Pfizer spokeswoman Kim Bencker told CNBC late in November that “no actual vaccine is being released until the FDA issues an authorization or approval.”

However, that didn’t stop the Trump administration from welcoming shipment after shipment of the experimental Pfizer formula into the country from Friday.

Rather than shipping the shot to hospitals, Pfizer has reportedly “pre-positioned” shipments at warehouses and other facilities near hospitals, which will supposedly allow healthcare professionals to begin vaccinating Americans within 24 hours of the jab’s approval.

There doesn’t seem to be any contingency plan in place if it’s not approved, even though the vaccine is highly sensitive to temperature and must be stored far below freezing in specially made containers.

The Federal Aviation Administration confirmed on Friday that the first shipment of the vaccine from its Brussels manufacturer had arrived, though a document obtained by CNN on Tuesday from the Trump administration’s Operation Warp Speed program suggested the first shipments wouldn’t be delivered until December 15.

The first shipments of Moderna’s vaccine, which uses a similar modality to Pfizer’s but need not be refrigerated at such cold temperatures, are expected to be delivered to hospitals on December 22, according to the document.

Both companies submitted applications to the FDA last month for an emergency review of their formulas, and the agency’s Vaccines and Related Biological Products Advisory Committee is due to meet next week to evaluate Pfizer’s clinical trial data.

From December 11 to 14, it is tasked with both reviewing the data and (along with the Centers for Disease Control’s Advisory Committee on Immunization Practices) deciding who should receive the jab first.

The following day, hospitals are supposed to start administering Pfizer’s vaccine.

If approved by the FDA, it would be the quickest rush to market of any jab in US history.

As soon as the committee gives the green light to Pfizer’s shot, it’s expected to briefly consider and then approve competitor Moderna’s jab – all before Christmas.

Even corona czar Anthony Fauci on Thursday acknowledged the downsides of “warp speed” as the drug was being shipped all over the US, observing “people are not going to want to get vaccinated” if the FDA goes through the approval process too “quickly” and “superficially.” He chided the UK’s own ultra-fast approval of the jab, saying “the UK did not do it as carefully” and only “got a couple of days ahead. ”

The rapid rollout has indeed caused a majority of Americans to balk at the idea of getting a COVID-19 vaccine, with two-thirds of those polled in September saying they’re unwilling to be in the first group to get the shot.

A quarter responded they weren’t interested in ever getting it, while a larger portion merely said they’d rather wait and see what happens to the first group to be vaccinated.

Doubters have hardly been reassured after the Defense Department announced earlier this week that those who receive the shot will receive “vaccine cards” to prove they’ve been inoculated – a possibility long denounced as a conspiracy theory by the media establishment.

While Pfizer has bragged its formula is 95 percent effective 28 days after the first dose, it hasn’t yet released detailed clinical trial data to the public, admitting last month that it will not be submitting safety and efficacy data for peer review until analysis of the data has been completed.

That hasn’t stopped the UK from rushing to be the first to approve the vaccine. Officials have reframed the rash decision as London “leading humanity’s charge” against the pandemic, and even suggested it makes the UK a “better country” than the US or the member nations of the EU, as the bloc has called for a lengthier evaluation process to increase public trust in the shot.

Source: TASS