Jakarta, HanTer – Several vaccine candidates must succeed in order for the world to eradicate the rising pandemic in the Americas, Europe and Asia. US hospitals have crossed the line as the country sees more than 160,000 new cases per day and more than 1,400 deaths each day. Since first appearing almost a year ago in China, the virus has killed more than 1.4 million people worldwide.
The pharmaceutical company Moderna Inc, on Monday (11/30/2020) asked the US and Europe to allow the emergency use of the Covid-19 vaccine, claiming that the results of a new study confirm that the injection offers strong protection. This increases the race to initiate limited vaccination due to the tantrum of the Corona virus which has only made matters worse.
Moderna is right behind Pfizer and its German counterpart, BioNTech, in a bid to start vaccination in the US in December. Across the Atlantic, UK regulators are also assessing Pfizer injections and others from AstraZeneca.
Moderna made its injections with the US National Institutes of Health and have had leads they were successful, but said it got the final results needed over the weekend that showed the vaccine was more than 94% effective.
Of the 196 Covid-19 cases so far in the large US study, 185 were trial participants who received the placebo and 11 who received the original vaccine. One in 30 seriously ill people, including one who died, had received fake injections, said Dr. Tal Zaks, the company’s Cambridge, Massachusetts chief medical officer.
When he learned of the results, “I allowed myself to cry for the first time,” Zaks told AP. “We have just been in trials, have saved many lives. Just imagine the impact then multiplied on people who can get this vaccine, “he added.
Moderna claims the effectiveness of the injections and a good safety record so far with flu-like side effects, so they meet the requirements set by the US Food and Drug Administration for emergency use before final testing is complete. The European Medicines Agency, the European version of the FDA, has signaled that they are also open to faster emergency clearance.
The FDA has promised that before deciding to launch a Covid-19 vaccine, its scientific advisers will publicly debate whether there is enough evidence behind each candidate. Scheduled for December 10, Pfizer and BioNTech will present data showing that their vaccine candidate is 95% effective, while Moderna said his turn in the “science court” was expected to be exactly a week later.
If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the US by the end of the year. The recipient will need two doses, so that’s enough for 10 million people. Meanwhile Pfizer expects 50 million doses globally by December. Half of them – or enough for 12.5 million people – are allocated to the US
This week, a panel of different US experts, set up by the Centers for Disease Control and Prevention, will meet to decide how the initial supplies will be delivered. They are expected to provide the rare first dose to health care workers and, if the injections work well enough in frail elderly, for residents of long-term care facilities.
As more vaccines gradually become available in the coming months, other important workers and people with the highest risk from the coronavirus will stand in line. But enough for the general population is not expected until at least spring.
Outside of the US, Zaks said a significant supply from Moderna would be available in the first quarter of 2021. “Obviously we are doing everything in our power to increase capacity and speed up schedules,” he said.
Both Moderna and Pfizer vaccines are made with the same technology, using snippets of the genetic code for the “spike” protein that infects the virus. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus does eventually arrive.
On the other hand, AstraZeneca last week announced the confusing preliminary results of its vaccine candidate from studies in the UK and Brazil. The vaccine appears to be only 62% effective when tested as originally intended, with recipients given two full doses. But due to production errors, a small number of volunteers received a lower first dose, which AstraZeneca previously said was likely to be 90% effective.
Experts say it’s unclear why a low-dose approach would work better and may be just a statistical peculiarity. A larger US study of candidate AstraZeneca is still underway that will ultimately give the FDA a better picture of how well it works. The FDA says the Covid-19 vaccine must be at least 50% effective.
Johnson & Johnson is also in its final stages of testing in the US and other countries to see if its vaccine candidate can work with just one dose. Both the J&J and AstraZeneca vaccines work by using a harmless flu virus to carry the spike protein gene into the body and boost the immune system.
Different technologies have an impact on how easily different vaccines can be distributed globally. AstraZeneca injections do not require freezer storage like the Pfizer and Moderna vaccines.
Candidates built with other technologies are still in the final stages of testing as well. Another US company, Novavax Inc., announced Monday that it had completed enrolling 15,000 people in the final UK study and plans to begin recruiting more volunteers for final testing in the US and Mexico in the coming weeks.
Then vaccines made by three Chinese companies and a candidate from Russia are also being tested on thousands of people in countries around the world.
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