Dispelling Covid-19 Vaccine Myths #06: Have Pfizer/BioNTech paid off the regulators?

Respected Doctor and Infectious Diseases Specialist, Simbarashe Takuva, has, over the past week, written a series of useful posts on his Facebook page dispelling myths about Covid-19 vaccines. They are really good and worth looking at, if only because they break down the science about the vaccine into simple facts based on the daily experiences of most readers. We’ve previously profiled him in this post and would recommend that you read the aforementioned posts on his Facebook profile.

The myths and conspiracy theories that Simba has tackled so far are the following:

• Myth #1: Vaccines alter your DNA
• Myth #2: Vaccines contain dangerous toxins
• Myth #3: Vaccine have toxic levels of aluminium
• Myth #4: I do not need to be vaccinated if Covid-19 levels are low where I live
• Myth #5: Some of these medicines are made to harm Africa/ developing nations.

In addition to this he has published a summary of why it’s been relatively easier to produce a vaccine for Covid-19 than for HIV. We love it when health professionals take time to simplify health information fir the general public, hence we encourage the wide dissemination of the information above.

In this post we start where Dr Simba left off by looking at a conspiracy theory currently doing the rounds on social media. This alleges that Pfizer and BioNTech have paid off regulators in order to gain access to the market for their vaccine. At the time of writing this post, at least six countries have given emergency use authorisation to the Pfizer/BioNTech Covid-19 vaccine. These include the U.K., Canada, Bahrain, Saudi Arabia, Mexico and the USA.

It is impossible to establish the validity of these claims since no concrete evidence of bribery has been presented. The allegations generally rely on vague examples of previous unethical behaviour by pharmaceutical companies.

We can start by evaluating the likelihood of such corruption occurring in any of the countries that have granted authorisation for vaccine use. For this, the most accessible tool is the Transparency International Corruption Index for each country. The latest available scores [2019] for Mexico (29/100), Bahrain (42/100) and Saudi Arabia (53/100) are relatively low, indicating a significant level of general corruption in those countries; while the USA (69/100), Canada (77/100) and the U.K. (77/100) score relatively highly. It is useful to remember that no country is perfectly clean and even the highest-ranked country, Denmark, has a rating of 87/100.

Does this therefore mean that there has been bribery in the granting of emergency use authorisations. Not necessarily. In the absence of any evidence we have to look at the process by which this authorisation is granted.

Let’s take the example of the U.K. The marketing of all prescription medication is heavily regulated in the UK. The Association of British Pharmaceutical Industries (ABPI) Code of Conduct makes it illegal for financial incentives to be provided to doctors to influence their decisions regarding the prescribing of medicines; or for attempts to be made to bribe regulatory authorities. The U.K. Bribery Act (2010) also not makes it illegal to commit acts of bribery; but also to pay “facilitation payments” anywhere in the world for companies that also trade in the U.K.

Penalties for breaches of the Act are severe, with up to ten-year imprisonment for individuals and unlimited fines for corporations. The Serious Fraud Office, which has a formidable international reputation, is responsible for investigations under the Act. It is difficult to imagine Pfizer and BioNTech taking the risks of damage to their reputations, registration and profitability by acting contrary to these acts.

There is a similar legal framework in the USA under the US Foreign Corrupt Practices Act (1977), details of which the reader may find on the internet.

We then look at the process for obtaining any authorisation for general human use of a vaccine or medication. It is not as simple as the CEO of Pfizer arranging a clandestine meeting with a government minister and then reaching an “agreement” for the minister to ensure that civil servants wave the application through.

Full data from clinical trials has to be submitted to the Medicines and Healthcare Products Regulatory Authority (MHRA), which then works with the Commission on Human Medicines (CHM) to evaluate the quality and findings before making a recommendation to the government on whether to approve the treatment for use. Both the MHRA and CHM are fully independent bodies by law.

The question is whether this process was followed in this case. The answer is that it was, as can be seen from this link.

In summary therefore, there are checks from several independent institutions in relation to the vaccine: government ministers, the Serious Fraud Office, the Police, the MHRA and the CHM. Those directly involved in the approval process are the MHRA, the CHM and the Government. It is hard to imagine Pfizer/ BioNTech paying off all the individuals in these institutions who are involved in the process.

In the extremely unlikely event that someone actually has concrete evidence that this highly unlikely crime did take place; we have friendly advice. The U.K. has a highly competitive and independent media. There are plenty of media channels that would pay handsomely for a scoop in relation to this. The evidence from the exposure of such scandals as the Panama Papers , Windrush, Oxfam, PPI, MPs’ Expenses and others indicates that these channels would be keen to see such evidence.