Vaccine Makers Pledge Caution on Covid Rollout

09.09.2020 - With some potential Covid-19 vaccine makers suggesting they could have a candidate ready for approval and maybe even deployment this autumn, concerns are arising that a doubting public could shun inoculation.

Vaccine skepticism has been observed on both sides the Atlantic. US skeptics have been the most vocal, amid fears that the Food and Drug Administration (FDA), pushed by a president seeking re-election, could issue an Emergency Use Authorization for an untested vaccine.

US surveys bear out this fear. A recent STAT/Harris poll found that 83% of Americans worried about the safety of a hastily produced vaccine, with 78% saying politics was driving the development more than science. In the latest poll by broadcaster CBS, only 21% said they would get the shot as soon as it became available, down from 32% in July.

Against this backdrop, the chief executives of nine vaccine manufacturers this week pledged not to seek regulatory approval before the safety and efficacy of their candidates have been established in Phase 3 trials designed and conducted to meet requirements of expert regulatory authorities such as the FDA.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which covid-19 vaccines are evaluated and may ultimately be approved,” the CEOs of AstraZeneca, Johnson & Johnson, Merck &Co, Moderna and Novavax, as well as the heads of two joint venture partners, Pfizer/BioNTech and Sanofi/ GlaxoSmithKline, said in a joint statement headlined “Biopharma Leaders United to Stand With Science.”

Having up to now collectively created 70 vaccines “that have helped to eradicate some of the world’s most complex and deadly public health threats,” the companies pointed to their years of experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health as a guarantee of ethical behavior.

The drugmakers did not say whether they would apply to the FDA for emergency authorization of a vaccine before Phase 3 trials are completed, as the health agency plans to allow if data from trials with 30,000 patients is made available. The BioNTech/Pfizer partnership, developer of the German biotech’s mRNA -based candidate, has been the most upbeat on the timeline, saying that if Phase 3 trials begun in July are successful, it could seek approval as early as October

Commenting on the Industry’s move to the forefront of the discussion, Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security, told US newspaper Washington Post that the pledge “reflects the fact that we have seen political meddling from the start in this pandemic response.”

Despite the president’s eagerness to have a vaccine before election day, former GSK executive Moncef Slaoui, who heads the government’s Operation Warp Speed vaccine deployment drive, told US public radio it is “very unlikely” a vaccine would be authorized before Nov. 3. Trump has reportedly told states to prepare to distribute vaccines by Nov. 1. Slaoui said separately he would resign if he detected “undue” political pressure.

European Parliament grills EU on vaccine safety

With the European political sector keeping more in the background, the discussion of a vaccine rollout timeline has been less charged on this side of the Atlantic. Nevertheless, concerns about safety and efficacy loom large.

At the beginning of this week, members of the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) grilled the EU Commission on efforts to develop, authorize and guarantee the safety of Covid-19 vaccines.

The dialog between the MEPs and Sandra Gallina, deputy director-general of the Commission's Directorate-General for Health and Food Safety, focused on the EU’s vaccines strategy, including the state of play on the vaccines advance purchase agreements sealed with manufacturers.

The parliamentary committee underlined the need for transparency to achieve trust in future vaccines and said it regretted that more information on the Commission’s work related to the purchase agreements for Covid-19 vaccines had not been shared proactively by the EU governing body.

Sidestepping the question somewhat, Gallina said a good vaccine must be efficient, safe, affordable, developed quickly and able to achieve EU market authorization, while stressing that the 27-member union is “fully committed” to a global approach in which vaccines must be available to all, including those in low-income countries.

In response to questions as to when vaccines will be available and who will be vaccinated first, Gallina said the first vaccinations should start toward the end of this year and a “significant number” should become available in the first part of 2021.

The EU official said vaccines would be distributed to member states based on population size and that the combined portfolio of different vaccines will be enough to vaccinate all citizens who need or want to be vaccinated. Country leaders will decide who will be vaccinated first. To assure affordability for all member states, the price per dose should be in the range of  €5-15.

Asked whether results of clinical trials would be made public, Gallina said the European Medicines Agency (EMA) will provide general data, although not all raw data. Access to clinical trial data will improve once the clinical trial regulation takes hold in late 2021, she added.

Addressing vaccine makers’ liability for faulty products, Gallina said that despite “difficult” negotiations, it was clear that the companies would be liable under current civil statutes, meaning they and could be sued. This would also apply to “compensation for hidden defects.”

On Sept. 22, the European Parliament will hold a public hearing in Brussels with the title “How to secure access to COVID-19 vaccines for EU citizens: clinical trials, production and distribution challenge.” Some vaccine manufacturers’ CEOs as well as representatives of the public and the research community are expected to attend.


Author: Dede Williams, Freelance Journalist