Supply Chain Woes Force Pfizer To Reduce COVID-19 Vaccine Production Target

Pfizer expects to ship only half of the COVID-19 vaccines it had initially planned after facing several supply chain challenges. Let’s read the complete story.

Last month, Pfizer Inc. released Opens a new window a statement regarding the shipment of COVID-19 vaccines for 2020 and 2021 based on its production estimates. However, the statement raised concerns over the challenges it is facing to develop a seamless supply chain for managing the rising demand for the drug. “Scaling up the raw material supply chain took longer than expected,” Pfizer’s representative said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”

Pfizer and Germany-based partner BioNTech SE had planned to roll out 100 million vaccines globally by the end of 2020. However, the supply chain woes have forced the drug makers to reduce it to 50 million now. Although Pfizer faces the tough task of building or having access to the desired logistics commensurate with global demand, it is still optimistic about rolling out billion-plus doses in 2021, as was originally planned in the initial ‘vaccine development’ blueprint. 

Pfizer further welcomed the U.K.’s decision on granting emergency-use authorization of the vaccine, as it became the first Western nation to begin dose administration. This nod from the U.K. government has only boosted Pfizer’s plans of reaching the global market by 2021 as planned. In the video below, 90-year-old Margaret Keenan, who is the first person to receive the Pfizer-BioNTech vaccine, can be seen taking the vaccine shot as the U.K.’s mass vaccination program began today. 

90-year-old Margaret Keenan is the first to receive the Pfizer/BioNTech vaccine, administered by Matron May Parsons, as UK’s mass vaccination programme begins pic.twitter.com/ltWAL8uDmrOpens a new window

— BBC Breaking News (@BBCBreaking) December 8, 2020Opens a new window

On the other hand, the Food and Drug Administration in the U.S. is currently reviewing the vaccine and is expected to give final authorization by the end of this month. On the clearance by the Food and Drug Administration, the vaccine may roll out immediately. Another drugmaker, Moderna Inc., is also being considered by the U.S. regulator to begin vaccine shipment before Christmas 2020. Hence, the U.S authorities seem to be tracking all the viable options at this juncture. 

The global death toll estimated by the U.S. authorities is close to about 1.5 millionOpens a new window and includes about 278,806 people residing in the U.S. as of December 7, 2020Opens a new window . Considering the impact of the pandemic, Pfizer’s plan of rolling out 100 million doses was in place until mid-November. 

However, considering the logistic arrangements at the time made it clear if Pfizer would be in a position to meet the end-of-the-year timeline. “We were late,” a person associated with the Pfizer vaccine development said. “Some early batches of the raw materials failed to meet the standards. We fixed it but ran out of time to meet this year’s projected shipments.”

In a general vaccination campaign, the drug manufacturing companies wait for the product approval from the concerned medical authorities before buying the necessary raw materials. Once the product is approved, the pharmaceutical companies then chalk out a plan for its manufacturing lines and set up requisite supply chains for shipping the vaccines. 

In Pfizer’s case, the company couldn’t scale up the vaccine’s production on time because it was waiting for the trial results, which eventually turned out to be 95% effective for about 44,000 subjects. As it awaited the vaccine approval, the company couldn’t procure the raw material beforehand from its prominent providers in the U.S. and Europe. This acted as a bottleneck for Pfizer as it wasn’t in a position to ramp up the production when the final approval was stamped. 

Besides, vaccines contain materials that are received from suppliers, such as antivirus agents, antiseptic liquids, sterile water, and elements of the DNA of the virus itself that essentially activate the immune system to produce antibodies. Considering Pfizer’s history, it has never manufactured a vaccine using a technology that relies on mRNA, where mRNA is a single-stranded RNA molecule that is complementary to one of the DNA strands of a gene and carries the genetic information to cells in the human body. This forced Pfizer to ramp up its manufacturing capacity, although the research was still underway and incomplete to comprehend on.

“For this one, everything happened simultaneously,” a source familiar with the Pfizer development said. “We started setting up the supply chain in March, while the vaccine was still being developed. That’s totally unprecedented.”

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What Can We Expect From Pfizer?

Despite the supply chain turmoil, Pfizer and BioNtech are on track and expected to roll out 1.3 billion vaccines in 2021. The drug manufacturers also expect to compensate for the 50 million dose shortfall this year by scaling up the production once the raw material supply, production estimates, and supply chain requirements are met to enable timely vaccine delivery.

The U.K. government released a statement in November, where it said that they could get up to 10 million doses by the end of 2020. However, with the current supply chain status, it can be expected that four to five million vaccines will be shipped. To tackle this shortfall, Pfizer is set to launch two final assembly and distribution centers in Kalamazoo, Mich., and Puurs, Belgium, that would manage the European supply. 

These centers will boost the U.K. government’s plans to vaccinate 20 million people as it has already ordered 40 million Pfizer doses. U.K. Health Secretary Matt Hancock confirmed that the shots will be rolled out as soon as they are made at the Pfizer’s Belgium plant. He further added that nearly 800,000 doses are due in the coming days and “several million” through December.

The efficacy of the Pfizer vaccine has motivated several countries, such as the U.S., U.K., and Japan, to order doses in advance. The U.S. government has already placed an initial order for 100 million doses, with the option to purchase 500 million additional doses, depending on the need. Similarly, the EU has ordered 200 million doses with an option for another 100 million. Japan joins the queue with an initial order of 120 million doses, along with countries in South America and Asia-Pacific.

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Cyberattack Threat Looms Large on the COVID-19 Vaccine Supply Chain

After the initial supply chain hiccups in 2020, Pfizer might as well brace itself to face another challenge of handling cyberattacks on their supply chains come 2021. Government authorities and health-care officials are gravely concerned about cyber thieves attacking the supply chain for COVID-19 vaccines, as the first vaccine is slated to roll out later this month. This can provide an opportunity to the attackers to target groups involved in shipping the vaccines.

Marc Rogers, the executive director of cybersecurity at software group Okta, toldOpens a new window The Hill on Friday, “We have noticed an uptick in attacks against all aspects of the vaccine supply-chain from research through to manufacturing and distribution,”

Rogers has led the COVID-19 CTI League and helped them track and defend against cybercrimes targeted at health groups. He noted that the league has observed “ramped up” cyberattacks in recent times that are specifically aimed at medical institutions involved in vaccine development.

“My suspicion is that all parties in the cybercriminal underground, from ordinary criminals to nation-states, recognize that the vaccines represent a golden opportunity and are responding as such,” Rogers further added.

The Wall Street Journal recently reported that North Korean hackers hacked into about six pharmaceutical groups across the U.S., the U.K, and South Korea. The common pattern seen here was that all these attacked groups were involved in developing a vaccine, including Johnson & Johnson and Novavax.

Earlier this week, Marene Allison, Johnson & Johnson’s Global CISO, saidOpens a new window , “All CISOs in health care are seeing attempted penetrations by nation-state actors, not just North Korea, every single minute of every single day,” Further, Novavax’s spokesperson told The Hill that the company was “aware of ongoing foreign threats identified in the news.”

However, with the concerns around the process of storing, shipping, and delivering COVID-19 vaccines once they are approved, cyberattackers are rooting for non-healthcare groups in the vaccine supply chain as they represent vulnerable targets that can be potentially attacked.

Pfizer’s recently rolled out vaccine requires cold storage groups to ship store COVID-19 vaccine candidates at extremely low temperatures. These cold storage groups have been on the radar of hackers. According to a new researchOpens a new window report by IBM Security X-Force, the cold chain is being targeted in a precision phishing campaign – implying that the campaign targets groups associated with cold storage facilities for the COVID-19 vaccine process. 

André Pienaar, the founder of C5 Capital, which helped form the Cyber Alliance to Defend Our Healthcare, told The Hill, “The point of attack in the supply chain that the hackers targeted have been the cold storage facilities. Cold storage companies are dismally underinvested in cybersecurity, and the hackers can enter their systems by hacking the industrial controls rather than phishing emails.”

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In Conclusion

As Pfizer’s vaccination campaign sets itself up for the final hurrah, a weak link in the vaccine supply chain remains exposed where alerts have been raised over cold chain security by IBM Security X-Force. While the COVID-19 vaccine rollout is good news for public health, it remains to be seen if the threat of cyberattacks (and other hurdles) will disrupt this process in 2021.

Do you think Pfizer will be able to negate the supply chain issues and come out stronger in 2021 by delivering COVID-19 vaccines at its full potential? Comment below or let us know on LinkedInOpens a new window , TwitterOpens a new window , or FacebookOpens a new window . We’d love to hear from you!