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Pfizer and BioNTech's COVID-19 vaccine
Pfizer (US) and partner BioNTech (Germany) have announced that a two-dose schedule of their mRNA-based COVID-19 vaccine candidate, BNT162b2, has demonstrated over 90% efficacy during an interim analysis of its late-stage trial, raising hopes that a vaccine could be just around the corner. One that not only elicits neutralizing antibodies and T-cell responses but could also have a meaningful impact at preventing infections and ending the COVID-19 pandemic. This is the first time that a vaccine against SARS-CoV-2 has demonstrated it could significantly reduce the chance of getting COVID-19, and although these are early interim results the high efficacy rate is not anticipated to change significantly during the final analysis, although the results may vary slightly. Most importantly these interim results are sufficient to file for emergency approval, at least in the US. The news is incredibly timely as the world faces fast-growing infections rates during the "second wave" that has forced some governments to reinstate lockdown measures.
The analysis was conducted by an independent Data Monitoring Committee (DMC) after the number of COVID-19 infections in the randomized study population reached 94 - the large majority of which turned out to be in the placebo arm. The vaccinated individuals in the study received a prime-boost schedule of the vaccine, 21 days apart, with data on COVID-19 infection collected starting from seven days after the second injection. The Phase III trial has enrolled 43,538 participants to date (including 38,955 that have already received the two doses), and will continue to enroll patients until the final analysis which will occur once 164 confirmed COVID-19 cases have been reported within the trial population. We do not have a lot of details on the demographics of the patient population included in the interim analysis yet, but Pfizer did disclose that 42% of participants globally, and 30% of US participants have racially and ethnically diverse backgrounds. Another unknown is how many vaccinated participants may have been asymptomatic spreaders of infection, as Pfizer's protocol limited data analysis to symptomatic patients. Additional detailed information about the safety and efficacy of the vaccine candidate will be published in the coming weeks.
Meanwhile, the company is sharing these positive results with regulatory authorities worldwide, as the partners prepare for a potential EUA submission "soon after the required safety milestone is achieved" next week. The probability of seeing a vaccine rollout in the US by Christmas has certainly increased significantly. But the US is not the only country set to receive the vaccine in the coming months.
Countries with BNT162b2 APAs likely to get it first
Pfizer has disclosed that it can provide 50 million vaccine doses in 2020 globally, and up to 1.3 billion doses in 2021. There are several countries and regions with publicized advanced purchase agreements (APAs) for Pfizer's vaccine according to our COVID-19 Vaccine APA Tracker, including the US (100-600 million), UK (40 million), European Union (300 million), Australia (10 million), Canada (20 million), Chile (10 million), Mexico (34.5 million), Peru (9.9 million), Japan (120 million), New Zealand (1.5 million), Kuwait (1 million), Qatar, Taiwan (30 million) as well as Hong Kong, and Macau (10 million). In total, the APAs already signed by Pfizer and BioNTech for the experimental vaccine currently reach nearly 1.2 billion, although not all APA doses were disclosed.
Exact timelines for delivery are rarely announced in these agreements, however, most doses will be delivered in 2021, with only a handful of regions anticipated to have access to doses of BNT162b2 in 2020. These including the US, the UK, and the European Union that could start receiving an initial batch this year, but this would also depend on authorization of the vaccine in those markets. The US EUA submission could be expected very soon, according to Pfizer, which could potentially lead to an authorized COVID-19 vaccine in the US by December 2020. Meanwhile, the UK is preparing to provide the vaccine as soon as possible, potentially this year, but a mass rollout is anticipated in the first part of next year. The most challenging part regarding transport and distribution of the vaccine will be ensuring that it remains at temperatures of -70 degrees Celsius, a feature that could unfortunately significantly impact access to the vaccine in regions less equipped for ultra-cold transport. Although Pfizer has developed a specialized cooler for transport, the very cold temperature requirements will be challenging for any facility, clinic, or hospital with limited availability of ultra-cold freezers.
COVID-19 vaccines set to break global sales records
Although Pfizer has yet to disclose the price of the vaccine, the purchase price could be estimated from APAs and purchase contracts that exclude additional funding for research and development. Pfizer is unique among drug developers with late-stage COVID-19 vaccine candidates in that it has opted to develop the vaccine, at its own risk, with limited support from governments. The US government has agreed to pay USD1.95 billion for 100 million doses of the vaccine, suggesting a purchase price of USD19.50 per dose, or USD39.00 for the two doses. This will likely vary from country to country, however, unlike other vaccine developers that have pledged to sell the vaccine at cost during the pandemic, Pfizer's CEO has already disclosed that the vaccine will be sold at a "very marginal profit." If all 1.3 billion doses are sold in 2021, the COVID-19 vaccine will certainly break global sales records. We track all advanced purchase agreements for COVID-19 vaccines, and associated pricing and expected delivery dates under each in a dedicated APA Tracker.
"A great day for science and humanity"
The success of BNT162b2 has not only set the efficacy bar high but has for the first time provided early evidence that the immunogenicity results stemming from SARS-CoV-2 immunization are in fact strong enough to prevent COVID-19 infection. Efficacy results for other promising COVID-19 vaccine candidates with comparable immunogenicity profiles to Pfizer's BNT162b2 are due in the coming weeks, with first data readings sped up considerably by the second wave, and this could further expand the pool of available tools to combat this virus. The CEO of Pfizer, Albert Bourla, issued a statement calling this "a great day for science and humanity", meanwhile, co-founder and CEO of BioNTech, Ugur Sahin, hailed the efficacy results as "a victory for innovation, science, and a global collaborative effort." Pfizer and BioNTech decided to collaborate on a COVID-19 vaccine only 10 months ago, and they have accomplished an unprecedented task - albeit with a very novel technology. Pfizer's and BioNTech's partnership dates to before the pandemic: the two firms have been collaborating on an influenza vaccine using BioNTech's mRNA-vaccine platform since 2018. If approved, the BNT162b2 COVID-19 vaccine will be the very first mRNA-based vaccine to garner marketing authorization. A victory for science indeed!
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Major changes to Czech P&R regulations for orphan and high-cost drugs set to expand access. What role will IRP play… https://t.co/bQcVCG5jut