Regulatory Open Forum

I have many responses and thoughts to this thread, but I'll post those I believe to be most constructive:

• For those would would like to 'see the data' I would highly recommend loading and refreshing the applicable VRBPAC page on the FDA website, as the briefing materials will be posted not less than 2 days prior to the respective committee meeting. So, for the Pfizer/BioNTech vaccine, that means Tuesday. As FDA has committed to a high level of transparency for this process, I would expect a large amount of information to be posted, likely looking similar to a traditional FDA review package. As others have also mentioned, the committee meeting itself will be broadcast live on various platforms; links are included on the same page.
• The discussion here has focused on the Ph3 efficacy trials which were initiated over the summer (late July for the earliest starts: Pfizer/BioNTech and Moderna), however sponsors continue following up on the earlier Ph1/2 studies that include specific subgroups. In fact, NIAID just posted 3 month data from Moderna's vaccine. While this is not the same duration data as would be obtained at this stage during a typical development timeline, it is something additional (plus, I'll note that journals continue to make these article freely accessible to the public, so everyone can read them).
• I'll remind everyone that all types of drug/biologic approvals include some risks; while the approval standards may differ between 'regular' approval, accelerated, EUA, etc., the sponsor and consequently FDA are performing a benefit/risk assessment in every situation, and virtually no drug is either 100% effective and/or 100% safe. This is codified in the statute (21 U.S.C. §355(d)), specifically: "The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs."
• As others have also mentioned, individuals are still able to make their own decisions in consultation with their healthcare providers. I'll note that many of us are fortunate enough to be able to work remotely and follow social distancing guidelines rather easily given the nature of our work, and many of us will be in later waves of the vaccination priority list. And, we also have the benefit of understanding the scientific and regulatory processes in play here. While there have been missteps along the way by various actors, I am personally confident in where we are at now and trust the FDA, CDC, and the scientific experts therein to make informed decisions based on the data. Meanwhile, I appreciate everyone who has done and continues to do their part to help human kind move forward while minimizing morbidity and mortality as much as possible.

I have many responses and thoughts to this thread, but I'll post those I believe to be most constructive:

• For those would would like to 'see the data' I would highly recommend loading and refreshing the applicable VRBPAC page on the FDA website, as the briefing materials will be posted not less than 2 days prior to the respective committee meeting. So, for the Pfizer/BioNTech vaccine, that means Tuesday. As FDA has committed to a high level of transparency for this process, I would expect a large amount of information to be posted, likely looking similar to a traditional FDA review package. As others have also mentioned, the committee meeting itself will be broadcast live on various platforms; links are included on the same page.
• The discussion here has focused on the Ph3 efficacy trials which were initiated over the summer (late July for the earliest starts: Pfizer/BioNTech and Moderna), however sponsors continue following up on the earlier Ph1/2 studies that include specific subgroups. In fact, NIAID just posted 3 month data from Moderna's vaccine. While this is not the same duration data as would be obtained at this stage during a typical development timeline, it is something additional (plus, I'll note that journals continue to make these article freely accessible to the public, so everyone can read them).
• I'll remind everyone that all types of drug/biologic approvals include some risks; while the approval standards may differ between 'regular' approval, accelerated, EUA, etc., the sponsor and consequently FDA are performing a benefit/risk assessment in every situation, and virtually no drug is either 100% effective and/or 100% safe. This is codified in the statute (21 U.S.C. §355(d)), specifically: "The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs."
• As others have also mentioned, individuals are still able to make their own decisions in consultation with their healthcare providers. I'll note that many of us are fortunate enough to be able to work remotely and follow social distancing guidelines rather easily given the nature of our work, and many of us will be in later waves of the vaccination priority list. And, we also have the benefit of understanding the scientific and regulatory processes in play here. While there have been missteps along the way by various actors, I am personally confident in where we are at now and trust the FDA, CDC, and the scientific experts therein to make informed decisions based on the data. Meanwhile, I appreciate everyone who has done and continues to do their part to help human kind move forward while minimizing morbidity and mortality as much as possible.

I have many responses and thoughts to this thread, but I'll post those I believe to be most constructive:

• For those would would like to 'see the data' I would highly recommend loading and refreshing the applicable VRBPAC page on the FDA website, as the briefing materials will be posted not less than 2 days prior to the respective committee meeting. So, for the Pfizer/BioNTech vaccine, that means Tuesday. As FDA has committed to a high level of transparency for this process, I would expect a large amount of information to be posted, likely looking similar to a traditional FDA review package. As others have also mentioned, the committee meeting itself will be broadcast live on various platforms; links are included on the same page.
• The discussion here has focused on the Ph3 efficacy trials which were initiated over the summer (late July for the earliest starts: Pfizer/BioNTech and Moderna), however sponsors continue following up on the earlier Ph1/2 studies that include specific subgroups. In fact, NIAID just posted 3 month data from Moderna's vaccine. While this is not the same duration data as would be obtained at this stage during a typical development timeline, it is something additional (plus, I'll note that journals continue to make these article freely accessible to the public, so everyone can read them).
• I'll remind everyone that all types of drug/biologic approvals include some risks; while the approval standards may differ between 'regular' approval, accelerated, EUA, etc., the sponsor and consequently FDA are performing a benefit/risk assessment in every situation, and virtually no drug is either 100% effective and/or 100% safe. This is codified in the statute (21 U.S.C. §355(d)), specifically: "The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs."
• As others have also mentioned, individuals are still able to make their own decisions in consultation with their healthcare providers. I'll note that many of us are fortunate enough to be able to work remotely and follow social distancing guidelines rather easily given the nature of our work, and many of us will be in later waves of the vaccination priority list. And, we also have the benefit of understanding the scientific and regulatory processes in play here. While there have been missteps along the way by various actors, I am personally confident in where we are at now and trust the FDA, CDC, and the scientific experts therein to make informed decisions based on the data. Meanwhile, I appreciate everyone who has done and continues to do their part to help human kind move forward while minimizing morbidity and mortality as much as possible.

As I said previously, trust is antithetical to RA, QA, risk management.  Especially risk management, I think.  Trust seems to be what people do as an alternative to risk management, which requires a tolerance for uncertainty.  Reagan's "trust but verify" has a nice oratorical ring to it, but if you verify, then of course trust becomes irrelevant.  If you can't verify, and you can tolerate uncertainty, you accept that you simply don't know, and trust again becomes irrelevant.  Those who can't tolerate that uncertainty, trust, which to me has an air of denial and blind faith about it, closer to religion than science.

As I also said previously, it's been a long pandemic. A leap from "Don't trust FDA reviewers" to "Never take medicine or get vaccinated," seems like a depressingly long way from the nuanced mindset of "it depends."  I'm tired, so I'll leave those who make that kind of leap to remain planted where they landed.

As for how our current situation is different from "old normal"...Really?

I have many responses and thoughts to this thread, but I'll post those I believe to be most constructive:

• For those would would like to 'see the data' I would highly recommend loading and refreshing the applicable VRBPAC page on the FDA website, as the briefing materials will be posted not less than 2 days prior to the respective committee meeting. So, for the Pfizer/BioNTech vaccine, that means Tuesday. As FDA has committed to a high level of transparency for this process, I would expect a large amount of information to be posted, likely looking similar to a traditional FDA review package. As others have also mentioned, the committee meeting itself will be broadcast live on various platforms; links are included on the same page.
• The discussion here has focused on the Ph3 efficacy trials which were initiated over the summer (late July for the earliest starts: Pfizer/BioNTech and Moderna), however sponsors continue following up on the earlier Ph1/2 studies that include specific subgroups. In fact, NIAID just posted 3 month data from Moderna's vaccine. While this is not the same duration data as would be obtained at this stage during a typical development timeline, it is something additional (plus, I'll note that journals continue to make these article freely accessible to the public, so everyone can read them).
• I'll remind everyone that all types of drug/biologic approvals include some risks; while the approval standards may differ between 'regular' approval, accelerated, EUA, etc., the sponsor and consequently FDA are performing a benefit/risk assessment in every situation, and virtually no drug is either 100% effective and/or 100% safe. This is codified in the statute (21 U.S.C. §355(d)), specifically: "The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs."
• As others have also mentioned, individuals are still able to make their own decisions in consultation with their healthcare providers. I'll note that many of us are fortunate enough to be able to work remotely and follow social distancing guidelines rather easily given the nature of our work, and many of us will be in later waves of the vaccination priority list. And, we also have the benefit of understanding the scientific and regulatory processes in play here. While there have been missteps along the way by various actors, I am personally confident in where we are at now and trust the FDA, CDC, and the scientific experts therein to make informed decisions based on the data. Meanwhile, I appreciate everyone who has done and continues to do their part to help human kind move forward while minimizing morbidity and mortality as much as possible.