The race for the Covid-19 vaccine launch is in full gear. Two top contenders in the race include Moderna and Pfizer-BioNTech. Both the companies have applied for emergency EU approval on Tuesday. Regardless, it is important to note that uncertainty over the rollout of the vaccine this year has been clouding over for some time.
Applications to the European Medicines Agency (EMA) arrived only a day after Moderna sought emergency use for its shot in the United States. Pfizer and BioNTech have also done the same a week ago.
The US drug manufacturer Pfizer and its German partners BioNTech said that they could launch the vaccine in the EU as early as this month.
Sierk Poetting, BioNTech’s head of operations and finance said that they can start delivery within a few hours (of an approval). Furthermore, he said, “We have been stocking up. And everything that is there can really be distributed within a few hours.”
EU’s decision will be based on EMA’s review completion
However, the EMA dimmed the timeline. EMA said that the completion of the review for the Pfizer-BioNTech vaccine will be done by December 29 at the latest. Review for Moderna’s shot will be by January 12. Moreover, they said that their schedule is subjected to change as the evaluation goes on.
This also affects the decision of the EU executive body, the European Commission. It said that they are likely to finally authorize for the vaccine’s rollout days after the EMA’s recommendation.
The coronavirus pandemic has claimed over 1.4 million lives worldwide. It has also plundered economies globally. An effective immunization can only lead to normalcy. Scientists are testing around 50 potential vaccines on volunteers around the globe.
Both US Biotech firms Moderna and Pfizer-BioNTech have reported preliminary findings of more than 90% effectiveness. This is also an unpredictably high rate in the vaccine trials. Both of them are also based on new messenger RNA (mRNA) technology.
Both Moderna and Pfizer-BioNTech have come up with a customized genetic code
The firms have worked on the idea that the human body can act as its own vaccine factory. Many biotech experts have been trying to assert this once-unorthodox idea for years.
Both inoculations work by injecting people with a customized genetic code. This code in turn will instruct the human cells to produce key virus proteins to induce an immune response.
On November 18, Pfizer and BioNTech submitted their final trial results. The results showed that their vaccine candidate, BNT162b2 was 95% effective in preventing Covid-19. They also confirmed that there were no major safety concerns. On the other hand, Moderna Inc reported on Monday that their full results from a late-stage show 94.1% effectiveness against the virus. Their candidate named mRNA-1273 also showed no major safety concerns.
Any kind of clearance from the EU and the US for the vaccines will be “conditional” or for “emergency use”. Therefore, the developers are compelled to continue their trials and submit more trial results as they come.
The EMA had started the European filings complete so-called rolling reviews. It started the Pfizer case on October 6 and the Moderna one on November 16. It aims to accelerate the process by performing a real-time data assessment as it lands.
On Tuesday, the EMA stated that they have started a rolling review of Johnson & Johnson’s vaccine candidate. This is after preliminary results showed that it triggered antibody and immune cell production against the virus. It also said that the review will continue until there is enough evidence for a formal marketing authorization application.
According to the British Government, Pfizer and BioNTech have submitted the clinical trials data to the Medicines and Healthcare products Regulatory Agency (MHRA) last week.