Ahead of FDA Review, Pfizer’s COVID Vaccine Endures See-Saw Day Including Approval in Canada

December 9th, 2020 – After the UK and Bahrain, Canada today has greenlighted Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, making it the first COVID-19 vaccine and the first mRNA-based vaccine to be approved in the country. Health Canada, the department responsible for the country’s health policy, has granted Authorization under Interim Order for the emergency use of BNT162b2 after rigorously reviewing Pfizer’s rolling submission. “Canada reached a critical milestone in its fight against COVID-19,” the agency said in a press statement.

“This a momentous occasion,” said Dr. Supriya Sharma, Chief Medical Adviser at Health Canada. “The geek in me is amazed. No one would have thought, even when we looked back at the first discovery of the virus, that less than a year later, we would be authorizing and distributing a vaccine.”

“It is a good day for Canadians,” remarked Canadian Prime Minister Justin Trudeau. “We will see 30,000 vaccines begin to arrive next week with many more on the horizon, but … we’ve got a tough winter to get through,” he added.

Allergy Warning for BNT162b2

The UK, the first country to approve Pfizer’s COVID-19 vaccine for emergency use, began its COVID vaccination program on December 8th, a week after the historic approval. Elderly residents in care homes and their carers, people aged 80 and over, frontline and social care workers including the ones from Britain’s National Health Service (NHS), were among the first who received the shot. Margaret Keenan, a 90-year-old grandmother, became the first recipient of the massive vaccine rollout.

“I feel so privileged to be the first person vaccinated against COVID-19, it’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year,” said Margaret. “I can’t thank May and the NHS staff enough who have looked after me tremendously, and my advice to anyone offered the vaccine is to take it – if I can have it at 90, then you can have it too!” she added emphatically.

However, two healthcare workers of the NHS experienced allergic reactions a day after receiving the shot. Both staff members carry an adrenaline auto-injector, which suggests they have had a history of allergic reactions. As a result, on Wednesday, the UK health authorities advised people who suffer from a “significant history of allergic reactions” to give the vaccine a miss.

“As is common with new vaccines, the MHRA has advised, on a precautionary basis, that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday,’’ Professor Stephen Powis, National Medical Director for the NHS said in a statement. “Both are recovering well.”

EMA Subjected to Cyber Attack

Within a few hours of the allergy news in the UK, Pfizer’s regulatory march in the EU also suffered a minor hiccup. Earlier today, the European Medicines Agency (EMA) reported a cyberattack on its server by unknown hackers. Citing ongoing investigations, it refrained from providing any further information. Although, BioNTech said it was informed by the EMA about unlawful access of regulatory documents pertaining to the submission of BNT162b2. Nevertheless, the agency has assured that the hack will not impact the timeline of vaccine review, which is expected in a few weeks.

Hopes for a Favorable FDA Review

Despite this, the outcome of BNT162b2’s regulatory review in the US, the country with the most COVID-19 deaths, will be the most anticipated news on December 10th. The final analysis of BNT162b2’s Phase 3 trial revealed that it met all of the primary efficacy endpoints, registering an efficacy of 95% with no safety issues. On the back of those strong results, Pfizer and BioNTech submitted the emergency use authorization request to the FDA on November 20th.

Notably, the commencement of the UK’s COVID-19 vaccination program coincided with an important regulatory landmark for BNT162b2 on the other side of the Atlantic. On December 8th, the FDA officials released a detailed analysis document stating that the two-dose vaccine was “highly effective” and, in some cases, provided benefits even after the first injection.

“FDA has reviewed the chemistry, manufacturing, and control (CMC) data submitted to date for this vaccine and has determined that the CMC information is consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19. As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” said the agency in the statement.

Considering the agency’s favorable assessment, one would expect the advisory committee comprising of outside experts to extend a positive review for the vaccine. The voting is scheduled to take place all day on December 10th. Nevertheless, the agency will closely discuss allergic reactions and may issue a warning.

“Looking into the data, patients or subjects with severe allergic reaction history have been excluded from the clinical trial,” said Moncef Slaoui, Chief Advisor to Operation Warp Speed. “I assume — because the FDA will make those decisions — that tomorrow this will be part of the consideration, and as in the UK, the expectation would be that subjects with known severe reactions, (will be asked) to not take the vaccine until we understand exactly what happened here.”

By Rajaneesh K. Gopinath, Ph.D.

References

1. https://www.canada.ca/en/health-canada/news/2020/12/health-canada-authorizes-first-covid-19-vaccine.html
2. https://www.ema.europa.eu/en/news/cyberattack-european-medicines-agency
3. https://investors.biontech.de/news-releases/news-release-details/statement-regarding-cyber-attack-european-medicines-agency
4. https://www.reuters.com/article/health-coronavirus-britain-vaccine/uk-issues-anaphylaxis-warning-on-pfizer-vaccine-after-adverse-reactions-idUSKBN28J1D1
5. https://www.fda.gov/media/144245/download

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Author

Rajaneesh K. Gopinath