US FDA Commissioner Stephen Hahn Signals Approval of Pfizer Vaccine – Tells CDC To Get Ready For Rollout
Medicines & Vaccines 11/12/2020 • &

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Commissioner Stephen Hahn said that the FDA had notified the officials handling vaccine distribution logistics for the US’ ‘Operation Warp Speed’ so they can begin timely execution of their plans.

United States Food and Drug Agency Commissioner Stephen Hahn Friday said that the agency will “rapidly work toward the finalization and issuance of an emergency use authorization” for the cutting edge Pfizer/BioNTech COVID-19 vaccine – following a vote by an independent FDA expert panel on Thursday recommending that the vaccine be approved.

Hahn said that the FDA had notified the US Centers for Disease Control and Prevention and officials handling vaccine distribution logistics for the US’ ‘Operation Warp Speed’ “so they can execute their plans for timely distribution” of the vaccine across the country. Currently, the US has more than 6 million active cases of COVID-19 and is seeing new cases reported at a rate of 200,000 a day.

The daily confirmed cases in the current 10 most affected countries.
US FDA Approval – Signal For WHO & The World

US FDA approval will not only open the floodgates of vaccine distribution in the United States. As the world’s flagship regulatory agency, it will send a strong signal to the rest of the world that the vaccine is effective and safe. The European Medicines Agency is next set to review the Pfizer request on 12 January.

To speed up regulatory approvals elsewhere in the world, WHO will also be issuing its own “Emergency Use Licenses (EUL)” for quality-assured vaccines, WHO Chief Scientist Soumya Swaminathan said at WHO’s Friday press conference.

She noted that the WHO assessments would be done with a number of other national regulatory agencies – and could then provide a  “stamp of efficacy and manufacturing quality”, upon which other countries could rely. The approvals would also support more rapid distribution of vaccines through the WHO co-sponsored COVAX vaccine facility.

Soumya Swaminathan, WHO Chief Scientist.

“We have asked countries to either accept the WHO EUL or another stringent regulatory agency approval,” said Swaminathan. “What we don’t want is for every country to start their own national assessment because that will take a lot of time.”

She said that WHO will review vaccines submitted to the agency for approval on a rolling basis as Phase III trials are completed.

“We expect in the coming weeks we will be reviewing the Pfizer-BioNTech vaccine and coming out with something,” Swaminathan said, adding that she expected the Moderna and AstraZeneca vaccines to be next in line.

“Products issued by a stringent regulatory authority can also be used by the COVAX facility so there will be no barrier to speedy use,” added WHO’s Bruce Aylward, a senior advisor to the WHO Director General.

FDA Recommendation Is Not Without Reservations – Concerns About Vaccine Allergy & Hesitancy

Thursday’s 17 to 4 vote, with 1 abstention, by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) reflected the overall high level of confidence that the vaccine had earned – but also some reservations.

Those centered largely around the safety of vaccines in young people and other vulnerable populations, as well as how vaccination centres would cope with potential allergic reactions – following two instances in the United Kingdom, which began rolling out the vaccine on Tuesday.

Reports of UK healthcare workers experiencing allergic reactions to Pfizer’s vaccine may have a negative impact on vaccine uptake in the US, the panel noted.

Two healthcare workers in the UK experienced allergic reactions after their injection on Tuesday, leading the British Medicines and Healthcare products Regulatory Agency (MHRA) to issue a warning that anyone with a history of severe allergies should refrain from getting the jab.

The two workers – who are believed to have suffered anaphylactoid reactions (less severe than anaphylaxis) – had a history of allergies, and are recovering well.

While there is currently not enough data to suggest how likely or severe a reaction could be, the FDA experts expressed concerns about how public concerns around allergic reactions could also impact vaccine uptake.

Tens of millions of Americans with a history of severe allergic reactions could now be hesitant to receive an injection, Paul Offit, vaccinologist from the Children’s Hospital of Philadelphia, said during the FDA panel meeting, which was broadcast live.

The FDA expert review group was already aware of the possibility that the Pfizer vaccine could cause an allergic reaction, prior to the occurrences in the UK when it launched its vaccination campaign on Tuesday.

This could have a significant impact on attempts to reach high levels of overall immunity, even as the most recent surveys show that the number of Americans willing to be vaccinated has risen to 6 in 10.

However, the FDA expert review group was already aware of the possibility that the Pfizer vaccine could cause an allergic reaction, prior to the occurrences in the UK.

Pfizer’s draft EUA had been updated several weeks ago warning that anyone with an allergy to a component of the vaccines should not get it, said Marion Gruber, director of the office of vaccines research and review at the FDA.

Equipment for dealing with severe allergic reactions should therefore be available on vaccine sites, the EUA draft request stated.

Questions Remain: Can Pregnant Women and 16 Year Olds Get the Vaccine?

A lack of sufficient data on the vaccine’s safety in pregnant and lactating women as well as adolescents aged 16-17 were the other key issues of debate among the expert panelists.

Pfizer’s EUA submission only included data on 153 participants aged 16-17. The overall lack of data appeared to be the main source of the concern, with no clear negatives or side effects specific to this age group reported.

As Offit noted: “We have clear evidence of a benefit. All we have on the other side is theoretical risk.”

Arnold Monto, an epidemiologist who chaired the panel, said: “We will get more data as we start using the vaccine more extensively. “With rare outcomes, you have to start using the vaccine in order to see them.”

It is highly unlikely the FDA will authorise a vaccine for these groups until a reproductive toxicity study is complete.

The experts also were undecided about whether pregnant and lactating women should receive the vaccine – due to a similar lack of evidence in the Phase III study trials. Pregnant women are often excluded from such trials, at least at the initial phases, in order to avoid unknown long-term effects on their fetus.

Manufacturers have been told to conduct developmental and reproductive toxicity (DART) studies, which indicate if a vaccine presents any risk to a fetus. Pfizer has reported that its preliminary results will be ready within days.

Until these studies are complete, it is highly unlikely the FDA will authorise a vaccine for these groups.

Image Credits: BioNTech, US Senate, Johns Hopkins University & Medicine, WHO.

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