CATHY & I REGISTERED FOR COVID VACCINE SHOTS (#40):
Editor’s note: This is a look back at life in San Miguel de Allende with covid-19.
In SMA the vaccine will be the Sputnik V. This post was shared by our friend Jessica Frick-Liston, an administrator of the COVID-19 SMA website & FB page.
Weekly Update Mexico, February 5, 2021 The Weekly Update is designed to keep you informed regarding COVID-19 news in Mexico. It supplements and reinforces information provided through the COVID-19 SMA website or FB page, which should be read daily. Information comes from reliable sources, which are referenced throughout the article. I will keep these short and easy to read.
Which vaccines have been approved in Mexico so far?
Mexico has approved the Pfizer-BioNTech vaccine, the AstraZeneca vaccine, and the Sputnik V vaccine. Detail on each of the approved vaccines is provided below. Mexico has not approved any other vaccine to date. Other planned vaccines are discussed below.
Detail on the three approved vaccines:
The SARS-CoV-2 virus is studded with proteins that it uses to enter human cells. These so-called spike proteins make a tempting target for potential vaccines and treatments.The Pfizer vaccine is an mRNA (messenger ribonucleic acid) vaccine. The AstraZeneca and the Sputnik V vaccines are viral-vector vaccines. These vaccines contain instructions for the COVID-19 spike proteins carried in vectors that dissolve, leaving the spike protein instructions to trigger an immune response.
Unlike the Pfizer vaccine, which stores the instructions for the spike protein in single-stranded RNA, the AstraZeneca vaccine uses double-stranded DNA. The DNA for the spike protein is added to another virus called an adenovirus. Adenoviruses are common viruses that typically cause colds or flu-like symptoms. The AstraZeneca vaccine uses a modified version of a chimpanzee adenovirus that causes colds in chimpanzees. It can enter human cells, but it can’t replicate inside them.
Sputnik V has one key, clever difference from the AstraZeneca vaccine: It uses one adenovirus for the first dose (adenovirus-26) and a different adenovirus (adenovirus-5) for the second dose. In this way, it avoids the possibility of immunity to the first dose impacting the ability of the second dose to work efficiently. One issue is that a large percentage of people have pre-existing immunity to adenovirus-5, but that’s not a huge drawback if the efficacy is very high. A potentially promising alternative would be to try a combination of adenovirus-26 for the first shot and AstraZeneca’s adenoviral vector – made from a chimp adenovirus – for the second, which is exactly what the AstraZeneca and Sputnik V have agreed to do in a collaboration announced on Dec.11, 2020.
All vaccines have gone through three phase trials. Scientific data has been submitted and approved by the Mexican equivalent of the US FDA, which is called the Comision Federal para la Proteccion Contra Riesgos Sanitarios (COFEPRIS). Given the seriousness of the COVID-19 virus and its virulence, the third phase trial requirement has been shortened for emergency approval here in Mexico, as it has been in the US. If no significant negative impact on human subjects is detected during the third phase, the vaccine can be considered for emergency approval.
Pfizer: Pfizer randomly assigned 37,000 trial participants to receive either two shots of the vaccine or two saline shots (placebo). They waited for 7 days after the second shot for the immune response to occur and then counted any COVID-19 cases that occurred 7 days after that in both groups. Out of the 170 cases that occurred, only 8 were in the group vaccinated and the rest were in the group given the placebo. Four cases of Bell’s Palsy occurred, and an allergic reaction occurred in 3 individuals within around 10 minutes after they were given the shot. These were mainly in those who had prior allergic reactions to other drugs, but not all. Otherwise, the only negative reactions were fatigue and headaches after the second dose, pain at the injection site and muscle pain. To date, the occurrence of negative reactions have not been frequent or serious enough to prevent approval or take the vaccine off of the market.
AstraZeneca: The University of Oxford partnered with the British-Swedish company AstraZeneca to develop and test the AstraZeneca vaccine. This is also a two-dose vaccine, given four to twelve weeks apart in the four trials conducted in the UK, Brazil and South Africa. Over 20,000 participants were enrolled, assigned to the vaccinated and placebo groups. On December 8, 2020, The Lancet confirmed that AstraZeneca was well tolerated and that there were no serious safety events confirmed related to the vaccine. The participants were from diverse ethnic and geographic groups who were healthy or had stable underlying medical conditions.AstraZeneca has already been granted conditional marketing authorization (CMA) or emergency use in 20 countries, spanning four continents including a number of Latin American countries, India, Morocco and the UK. Phase III trial results are being released on a rolling basis. AstraZeneca’s COVID-19 vaccine has been recommended for CMA in the European Union (EU) for active immunization to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.https://www.astrazeneca.com/…/covid-19-vaccine…
Interestingly, a recent primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, was published as a preprint in The Lancet on February 2, 2021 showing that AstraZeneca efficacy after a single standard dose of vaccine from day 22 to day 90 post vaccination was 76%, and that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 day. Authors concluded that vaccination programs aimed at vaccinating a large proportion of the population with a single dose, with a second dose given after a 3-month period is an effective strategy for reducing disease, and may be the optimal for rollout of a pandemic vaccine when supplies are limited in the short term.
Sputnik V: Jessica has done an excellent job of summarizing the details of the Sputnik V vaccine. Rather than repeat that here, please refer to the COVID-19 SMA FB page, specifically, these two posts:https://www.facebook.com/…/permalink/1307665046272459/https://www.facebook.com/…/permalink/1304466399925657/
What is the Cold Chain and why is it important?The Cold Chain refers to the chain of different cold storage devices (cold containers, refrigerators, ice chests, thermoses, vials, etc.) that are critically needed to maintain a vaccine at its required temperature as it moves on its journey from the manufacturer to the moment it is injected into people’s arms.
Approved COVID-19 vaccines are being flown to Mexico from the manufacturer at critically defined temperatures, then moved quickly to their destinations. If at any point during the chain (air-cargo, trucking, hospital storage, transfer to remote clinics, etc.) the vaccine deviates from its required temperature, the vaccine will expire and cannot be used. As you can imagine, unintentional breaks in the chain could happen any place along the journey from the manufacturing plant to your arm. Breaks in the Cold Chain result every year to in a loss of many different types of vaccines. Although this can happen anywhere, in any country, the cold chain is especially challenging in countries like Mexico, with scarce resources and disperse rural communities.
Having said that, however, with assistance from the WHO, the Pan-American Health Organization and UNICEF, developing countries often have more experience than developed countries in mounting large-scale vaccination campaigns. The brigade concept being put into practice by the Mexican government for the vaccination of the elderly could be an example of that.
The Pfizer vaccine is especially tricky since it must be kept at a continuous -94F (-70C) from the manufacturer to the place where it will be stored – usually a hospital that is capable of storing vaccines at extremely low temperatures. The State of Guanajuato has said it is confident it will be able to ensure the cold-chain for the Pfizer vaccine. The Policy states that the Pfizer vaccine will be kept at -70C in super-freezers and thawed before use, each vial of five doses to be applied in less than six hours so that the vaccine stays intact.
The AstraZeneca vaccine cold chain will also be easier to handle as long as there is refrigeration. The AstraZeneca vaccine for Covid-19 is more rugged than the mRNA vaccines from Pfizer. DNA is not as fragile as RNA, and the adenovirus’s tough protein coat helps protect the genetic material inside. As a result, the AstraZeneca vaccine doesn’t have to stay frozen. The vaccine is expected to last for at least six months when refrigerated between two and eight degrees C (38–46°F).
Phase II: Once additional vaccines arrive for Phase II, and Phase I is completed, Mexico will begin vaccination of the elderly, beginning with those over 80, 70-79, 60-69, etc., until all those over 60 are vaccinated. Additional vaccine doses are expected to arrive in February.
• Registration of the elderly for the vaccine: In the past few days, the government has set up a website that will allow those over 60 years of age to register for a vaccine. The site: https://mivacuna.salud.gob.mx/. The site is in Spanish. If you have trouble entering the site, try using a newer computer or a different device or browser, or just keep trying. The site will be very busy. Once you are registered, someone from a Brigade and vaccination site near you will get in touch to give you an appointment. There is also a virtual button on the coronavirus.gov.mx website noted below. Here is a link to instructions on how to register: https://www.covid19sma.com/vaccination-registration-and…
• Phone calls to the elderly: The government COVID site has also recently stated that Servidores de la Nación, members of the vaccination Brigades, are calling the homes of the elderly, particularly those registered with the pension system, to ask if they intend to take the vaccine and if they plan to go personally to the vaccination location nearest to their home. They tell the elderly that the vaccination will take place in February. https://coronavirus.gob.mx/vacunacion-covid/
• Approach: According to the Mexico’s National Vaccination Policy, Version 4, January 11, 2021 https://coronavirus.gob.mx/…/01/PolVx_COVID_-11Ene2021.pdf , vaccinations for the elderly will be given by brigades made up of trained public servants and volunteers. Effort is referred to as Operativo Correcaminos. Each brigade will be set up in one of 10,000 Integrated Centers, to be located in the geographical center of 280,000 small, disperse communities in the country. Centers will be located where the elderly are accustomed to receive their pensions (a school, rural medical unit, a plaza, etc.). Each Center will vaccinate 300 elderly adults each week. In this way, Mexico will immunize a total of 3 million elderly persons in remote areas. Once the Centers are installed, the persons will receive their vaccine when they receive their bi-monthly pension. If the person does not come, a brigadista will go to their home. A group of authorities from the communities surrounding each Center will send a report of the vaccination campaign to the capital of each state.
Following this, vaccinations will proceed in the 2,500 municipalities or municipal heads, and then the largest cities. When the same brigades reach the large cities, they will work together, with each brigade responsible for vaccinating 300 persons a week. Once all of the elderly are vaccinated, vaccination will continue with persons under 60 who have chronic diseases, and with teachers under 60 years of age.
• Vaccination of Foreigners over 60 years of age living in Mexico:The Mexican government has confirmed its intention to vaccinate all foreigners living in Mexico. Vaccines will be free. As explained above, foreign residents over 60 years of age should register for a vaccine on the site https://mivacuna.salud.gob.mx/. In order to register for a vaccine, you must have a CURP number.If you are a Permanent or Temporary Resident, you probably have one. CURP stands for Clave Única de Registro de Población in Spanish, or Unique Population Registration Code in English. It functions similarly to social security numbers or fiscal codes in other countries. Every number is unique to the person it identifies. Once you acquire residency in Mexico, you can request your CURP. Firstly, check this address to see if your CURP is already available online: www.gob.mx/curp. If it is not available from this site, then print out the form you used in your search online. You can use this when you request the CURP from your local immigration (INM) office. For instructions on locating or applying for your CURP, please visit: https://www.covid19sma.com/vaccination-registration-and…
Vaccine Availability and Plans:
According to the Mexican government’s Covid-19 Daily Briefing, February 2, 2021, 100% of all vaccine shipments received to date except the last have been given to health workers (and some teachers in Campeche), with only 58% of the last shipment left. All vaccines received to date were received from Pfizer. The last shipment arrived mid-January. The remaining vaccines are being used to complete the second doses for health workers, with a small amount held in reserve for contingencies
.Information about the vaccine portfolio published in Mexico’s National Vaccination Policy, Version 4, January 11, 2021 https://coronavirus.gob.mx/…/01/PolVx_COVID_-11Ene2021.pdf is as follows: These sources will be used to provide the vaccines necessary to vaccinate at least 70% of Mexico. Other sources will be considered as they become available and pass the necessary trials and approvals.
• Pfizer-BioNTech. – to immunize 17.2 million people
• AstraZeneca – to immunize 30.8 million people
• CanSino Biologica- to immunize 35 million people
• COVAX mechanism – 25.8 million people
On January 29, 2021 the Mexican president reported that Mexico would have 6 million vaccine doses in country by the end of February. Pfizer agreed to renew its deliveries as of February 10th with 500,000 doses. A new agreement with AstraZeneca included delivery of 870,000 additional doses from India. Russia had also agreed to send 870,000 doses of Sputnik V. WHO, through the COVAX Mechanism would send 1,800,000 doses of a vaccine (unspecified) for February. In addition, once studies had been completed, 6,000,000 doses of the CanSino vaccine from China would be sent to Mexico
Since then, things have moved quickly:
During the Coronavirus Daily Briefing on February 1, 2021, the government reported that Mexico will receive between 1 and 2 million doses of AstraZeneca in the first 6 months of 2021 through WHO’s COVAX Mechanism.
On February 2, 2021, COFEPRIS authorized the emergency use of the Sputnik V vaccine in Mexico. The first shipment of 400,000 doses could arrive this month.
On February 2, 2021, Marcelo Abelard, the Secretario de Relaciones Exteriores de Mexico, announced that the active substance for the bottling of the AstraZeneca vaccine had arrived in Mexico. The vaccine will be ready for use in the country in February and March.
These vaccines, and possibly others, will be destined for Phase II, vaccination of the approximately 15 million persons over 60 years of age in the country.
And that’s it for now! I hope this has been useful. The next issue will include ongoing information on vaccines, the COVID-19 Variants, private sources of vaccines, and other subjects of interest.